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Royal Decree 709/2015 Of 24 July, The Essential Safety Requirements For The Marketing Of Pressure Equipment Are Set.

Original Language Title: Real Decreto 709/2015, de 24 de julio, por el que se establecen los requisitos esenciales de seguridad para la comercialización de los equipos a presión.

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on 29 May 1997, the European Parliament and the Council adopted Directive 97 /23/EC on the approximation of the laws of the Member States relating to pressure equipment. Directive 97 /23/EC has been repealed with effect from 19 July 2016 by Article 50 of Directive 2014 /68/EU of the European Parliament and of the Council of 15 May 2014 on the harmonisation of the laws of the Member States relating to the Member States on the placing on the market of pressure equipment.

In compliance with the obligations arising from the Treaty of Accession of Spain to the European Union, as well as the provisions of Article 49 of that Directive 2014 /68/EU of the European Parliament and of the Council of 15 May 2014, the national provisions adapting the Spanish legislation to the provisions of the said Directive should be issued.

The new Directive 2014 /68/EU of the European Parliament and of the Council of 15 May 2014 recasts the previous Directive 97 /23/EC of the European Parliament and of the Council of 29 May 1997 adapting its provisions to the new Community legislation and in particular to:

(a) Decision No 768 /2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products and repealing Council Decision 93 /465/EEC, which provides for the common principles and reference provisions applicable to all sectoral legislation in order to establish a coherent basis for the revision or recasting of such legislation.

(b) Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on the classification, labelling and packaging of substances and mixtures and amending and repealing Directives 67 /548/EEC and 1999 /45/EC and amending Regulation (EC) No 1907/2006 incorporates provisions on the hazard classification of the fluid contained in the pressure equipment.

(c) Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 laying down the requirements for accreditation and market surveillance relating to the placing on the market of products and products Regulation (EEC) No 339/93, which regulates the accreditation of conformity assessment bodies, adopts a framework for the surveillance of the market in products and for checks on products from third countries, and establishes the general principles of the CE marking.

This royal decree lays down the essential safety requirements for pressure equipment and assemblies which constitute a novelty on the European Union market at the time of entry into the European Union market; that is to say, which are either pressure equipment or new assemblies manufactured by a manufacturer established in the European Union, or are pressure equipment or new or second hand assemblies imported from a third country.

Compliance with such essential security requirements is necessary to ensure the safety of pressure equipment and assemblies. These requirements can be general for all teams and sets, and specific, for some only. In particular, the specific requirements shall apply to certain pressure equipment belonging to categories III and IV, which shall be subject to a final assessment comprising a final inspection and testing.

In order to facilitate the assessment of conformity with these requirements, a presumption of conformity is established for pressure equipment or assemblies which are designed and manufactured in accordance with the harmonised standards to be adopted, pursuant to Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation, in order to lay down detailed technical specifications for these requirements, in particular as regards the design, manufacture and testing of pressure equipment or assemblies.

In view of the nature of the risks posed by the use of pressure equipment and assemblies and to enable economic operators and competent authorities to demonstrate and ensure that the equipment under pressure or assemblies (a) the conformity assessment procedures are laid down in accordance with Article 2 (2) of Regulation (EU) No These procedures vary according to the degree of danger inherent in pressure equipment or assemblies. Therefore, for each category of pressure equipment there is an appropriate procedure or the possibility to choose between different procedures of equivalent rigour.

For this purpose, conformity assessment procedure modules are established, from the least strict to the most stringent, proportional to the existing risk level and the required level of safety. In order to ensure cross-sectoral consistency and to avoid "ad hoc" variants, conformity assessment procedures should be chosen between those modules. The details added to those procedures are justified by the nature of the verification required for the pressure equipment.

On the other hand, it is essential that all control bodies and all independent entities perform their functions of conformity assessment at the same level and in conditions of fair competition. As a result, requirements are laid down which must be complied with by the control bodies and independent entities wishing to be notified to the European Commission and the other Member States for the provision of assessment services. compliance.

Only those who have previously obtained their accreditation may be notified. The accreditation system is an essential means of verifying the competence of the control bodies. Transparent accreditation, which ensures the level of trust required in the certificates of conformity, is regarded as the appropriate way to demonstrate the technical competence of those control bodies and entities independent.

During the processing of this royal decree, the hearing procedure, provided for in Article 24.1.c) of Law 50/1997, of 27 November, of the Government, has been carried out to the representative entities of the sectors concerned. The Autonomous Communities have also been consulted and the mandatory report of the Council for the Coordination of Industrial Security has been obtained according to article 18.4.c) of Law 21/1992, of July 16, of Industry.

Finally, in order to comply with the provisions of Article 49.1 of Directive 2014 /68/EU, the approval of this royal decree must be communicated to the European Commission.

This provision is dictated by the provisions of Article 149.1.13. of the Spanish Constitution, which attributes to the State the competence to determine the bases and coordination of the general planning of the activity. without prejudice to the powers of the Autonomous Communities in the field of industry.

In its virtue, on the proposal of the Minister of Industry, Energy and Tourism, in agreement with the State Council, and after deliberation by the Council of Ministers at its meeting on 24 July 2015,

DISPONGO:

CHAPTER I

General provisions

Article 1. Object and scope of application.

1. It is the purpose of this royal decree to establish the essential safety requirements for pressure equipment and assemblies which are a novelty on the European Union market at the time of entry into the European Union. for placing on the market, in order to ensure a high level of protection of the health and safety of persons, as well as the protection of domestic animals and property.

For the purposes of demonstrating compliance with these essential safety requirements, different conformity assessment mechanisms are established, depending on the degree of danger of conformity assessment.

2. This royal decree applies to the design, manufacture and conformity assessment of pressure equipment and assemblies subjected to a maximum permissible pressure PS exceeding 0,5 bar.

3. They are excluded from the scope of this royal decree:

3.1 Driving pipes formed by a pipe or pipe system for the conduction of any fluid or substance to or from an installation (land or sea), from the last device of Insulation located on the perimeter of the installation, including such device and all gear equipment specially designed for the pipe. This exclusion does not cover standard pressure equipment such as those that can be found at decompression stations or at compression stations.

3.2 Networks for the supply, distribution and disposal of water, as well as their equipment and driving water pipelines, such as forced pipes, pressure tunnels or cargo galleries, for hydroelectric and hydroelectric installations its specific accessories.

3.3 Simple pressure vessels regulated by Directive 2014 /29/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the placing on the market of simple pressure vessels.

3.4 The aerosol generators regulated by Royal Decree 1381/2009 of 28 August 2009 laying down the requirements for the manufacture and marketing of aerosol dispensers.

3.5 Equipment for the operation of vehicles defined in the following rules:

(i) Royal Decree 750/2010 of 4 June 2010 governing the procedures for the approval of motor vehicles and their trailers, self-propelled or towed machinery, agricultural vehicles and systems, parts and parts thereof parts of such vehicles.

(ii) Regulation (EU) No 167/2013 of the European Parliament and of the Council of 5 February 2013 on the approval of agricultural or forestry vehicles and the surveillance of the market for such vehicles.

(iii) Regulation (EU) No 168/2013 of the European Parliament and of the Council of 15 January 2013 on the approval of two or three-wheel vehicles and four-wheel vehicles and on the market surveillance of such vehicles.

3.6 Equipment corresponding to category I maximum according to the provisions of Article 13 of this Royal Decree and which are covered by any of the following rules:

(i) Royal Decree 1644/2008 of 10 October 2008 laying down the rules for the placing on the market and putting into service of machinery.

(ii) Directive 2014 /33/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to lifts and safety components for lifts.

(iii) Directive 2014 /35/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the placing on the market of electrical equipment intended for use with certain voltage limits.

(iv) Royal Decree 414/1996 of 1 March for the regulation of medical devices.

(v) Royal Decree 1428/1992 of 27 November 1992 laying down detailed rules for the application of the Directive of the Council of the European Communities of 29 June 1990 on the approximation of the laws of the Member States relating to the Member States on gas appliances.

(vi) Directive 2014 /34/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to equipment and protective systems for use in atmospheres potentially explosive.

3.7 The equipment referred to in Article 346.1.b of the Treaty on the Functioning of the European Union (TFEU).

3.8 Equipment specifically designed for nuclear use, the breakdown of which can cause radioactive emissions.

3.9 The well control equipment used in the oil, gas or geothermal exploration and extraction industry as well as for underground storage, designed to contain or control the pressure of the wells. Such equipment will include the wellhead (Christmas tree), the anti-eruption devices ("Blow-out preemper", BOP), the pipes and collectors, as well as their previous auxiliary equipment.

3.10 Equipment containing coatings or mechanisms whose dimensions, selection of materials and manufacturing standards are based mainly on criteria of resistance, rigidity and stability sufficient to support the static and dynamic effects of operation or other characteristics related to its operation and for which the pressure does not constitute a significant design factor. Such equipment may include:

i) The engines, including turbines and internal combustion engines.

(ii) Steam machines, gas and steam turbines, turbogenerators, compressors, pumps and drive devices.

3.11 The blast furnaces, with their cooling systems, their hot-wind retrievers, their dust extractors and their blast furnace exhaust scrubbers, and the direct reduction cutlets, with their cooling, its gas converters and their vats of melting, recasting, degassing and moulding of steel, iron and non-ferrous metals.

3.12 High voltage electrical equipment, such as connectors and controls, transformers and rotary machines.

3.13 The pressurized covers surrounding the elements of transmission systems, such as electrical cables and telephone cables.

3.14 Ships, rockets, aircraft or mobile coastal units, as well as equipment specifically intended to be installed on board or to propel them.

3.15 Pressure equipment composed of a flexible cover, such as tyres, air cushions (mattresses), balls and balls, inflatable boats and other similar pressure equipment.

3.16 The exhaust and intake silencers.

3.17 Metal bottles or cans for carbon drinks intended for final consumption.

3.18 The containers intended for the transport and distribution of beverages of which the product of PS × V does not exceed 500 bar per litre and whose maximum permissible pressure does not exceed 7 bar.

3.19 The equipment covered by the ADR (European Agreement on the International Carriage of Dangerous Goods by Land), RID (Regulation on the international transport of dangerous goods by land) railway), IMDG (International Maritime Code for Dangerous Goods) and ICAO (International Civil Aviation Convention), as well as by Royal Decree 97/2014 of 14 February on the rules governing the carriage of goods dangerous by road in Spanish territory and Royal Decree 1388/2011 of 14 October 2011, on the application of Directive 2010 /35/EU of the European Parliament and of the Council of 16 June 2010 on transportable pressure equipment and repealing the provisions of Directive 2010 /35/EU of the European Parliament and of the Council Directives 76 /767/EEC, 84 /525/EEC, 84 /526/EEC, 84 /527/EEC and 1999 /36/EC.

3.20 Radiators and tubes in hot water heating systems.

3.21 The containers intended to contain liquids whose gas pressure above the liquid does not exceed 0,5 bar.

Article 2. Definitions.

For the purposes of this royal decree, it is understood by:

1. Pressure equipment: containers, pipes, safety fittings and pressure fittings. Where appropriate, the elements attached to the pressure parts, such as flanges, tubers, couplings, clamps, supports, hoists for hoisting, etc., shall be considered to be part of the pressure equipment.

2. Container: a cover designed and constructed to contain pressure fluids, including direct mounting elements up to the intended device for connection with other equipment. A canister may consist of more than one chamber.

3. Pipes: means of channeling for the conduction of fluids, when they are connected to be integrated in a pressure system. The pipes comprise, in particular, a tube or a tube system, the ducts, adjustment pieces, expansion joints, flexible tubes or, where appropriate, other pressure-resistant elements. Pipes shall be equipped with heat exchangers consisting of tubes and intended for cooling or air heating.

4. Safety accessories: devices intended for the protection of equipment under pressure in the face of exceeding the permissible limits. These devices may be:

i) Organs for direct pressure limitation, such as safety valves, breakage disc safety devices, buckling rods, and targeted safety devices (CSPRS).

(ii) limiting organs which actuate means of intervention or produce unemployment or unemployment and closure, such as presostats, temperature-driven switches or the level of fluid and devices of " measurement, control and regulation having a security function (SRMCR) ".

5. Pressure accessories: devices for operational purposes, the cover of which is under pressure.

6. Assemblies: several pressure equipment assembled by a manufacturer in a manner that constitutes a functional installation.

7. Pressure: the pressure on the atmospheric pressure, i.e. the pressure of the manometric pressure. Consequently, the vacuum is expressed by a negative value.

8. Maximum permissible pressure (PS): the maximum pressure for which the equipment specified by the manufacturer is designed.

It will be defined in a location specified by the manufacturer, which will be the place of connection of the protective or security devices or the top of the equipment or, if this is not appropriate, any other specified location.

9. Maximum permissible temperature/minimum temperature (TS): the maximum and minimum temperatures for which the equipment is designed, specified by the manufacturer.

10. Volume (V): the internal volume of a camera, including the volume of the tubers to the first connection or welding and excluding the volume of the permanent internal elements.

11. Nominal diameter (DN): a figure of identification of the diameter common to all the elements of a pipe system, except for the elements indicated by its external diameters or by the size of the thread; it shall be a rounded number for the purposes of reference, with no strict relation to the manufacturing dimensions. It will be named with the letters DN followed by a number.

12. Fluids: gases, liquids and vapours in pure phase or in mixtures. A fluid may contain a suspension of solids.

13. Permanent joins: junctions that can only be separated by destructive methods.

14. European material approval: a technical document defining the characteristics of materials intended for repeated use in the manufacture of pressure equipment, which are not subject to harmonised standards.

15. Marketing: any paid or free supply "in the course of a commercial activity" of pressure equipment or assemblies for distribution or use on the European Union market.

16. Market introduction: the first placing on the market of pressure equipment or assemblies on the European Union market.

17. Putting into service: the first use of a pressure equipment or a set by the user.

18. Manufacturer: any natural or legal person who manufactures or orders to design or manufacture a pressure equipment or assembly and markets them under his or her name or brand or uses them for their own purposes.

19. Authorised representative: any natural or legal person established in the European Union who has received a written mandate from a manufacturer to act on his behalf on specific tasks.

20. Importer: any natural or legal person established in the European Union who introduces pressure equipment or sets from a third country on the European Union market.

21. Distributor: any natural or legal person in the supply chain, other than the manufacturer or the importer, who markets equipment under pressure or assemblies.

22. Economic operators: the manufacturer, the authorised representative, the importer and the distributor.

23. Technical specification: a document defining the technical requirements of pressure equipment or assemblies.

24. Harmonised standard: harmonised standard as defined in point (c) of point 1 of Article 2 of Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation, amending Council Directives 89 /686/EEC and 93 /15/EEC and Directives 94 /9/EC, 94 /25/EC, 95 /16/EC, 97 /23/EC, 98 /34/EC, 2004 /22/EC, 2007 /23/EC, 2009 /23/EC and 2009 /105/EC of the European Parliament and of the Council and repealing Council Decision 87 /95/EEC Council and Decision No 1673 /2006/EC of the European Parliament and of the Council.

25. Accreditation: accreditation in accordance with the definition of Article 2 (10) of Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 laying down the requirements for accreditation and surveillance of the the market for the placing on the market of the products and repealing Regulation (EEC) No 339/93.

26. National accreditation body: national accreditation body as defined in point 11 of Article 2 of Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008.

27. Conformity assessment: the process by which it is assessed whether the essential safety requirements of this royal decree are met in relation to pressure equipment or assemblies.

28. Conformity assessment body: a control body that performs conformity assessment activities, including calibration, testing, certification and inspection.

29. Recovery: any measure aimed at obtaining the return of pressure equipment or sets already made available to consumers or other users.

30. Withdrawal: any measure intended to prevent the placing on the market of pressure equipment or assemblies in the supply chain.

31. CE marking: the marking by which the manufacturer indicates that the pressure equipment or assembly complies with all applicable requirements laid down in the European Union harmonisation legislation establishing the affixing of the marking.

32. European Union harmonisation legislation: any legislation of the European Union which harmonises the conditions for the marketing of products.

33. Notified control bodies: those complying with the provisions of Royal Decree 2200/1995 of 28 December 1995 on the Regulation of the infrastructure for industrial quality and safety and Article 21 of the Royal Decree of 28 December 1995 a decree, and are notified to the European Commission and the other Member States to carry out the conformity assessment tasks referred to in Articles 14 and 15.

34. Independent entities: those which comply with the provisions of Royal Decree 2200/1995 of 28 December 1995 and Article 21 of this Royal Decree and are notified to the European Commission and the other Member States for the purpose of carrying out those tasks referred to in paragraphs 3.1.2 and 3.1.3 of Annex I.

Article 3. Marketing and commissioning.

1. Only pressure equipment and assemblies referred to in Article 1 may be placed on the market and put into service if they do not compromise the safety or health of persons or, where appropriate, domestic animals or property, including the environment, when properly installed and maintained and used in accordance with their intended use and meet the requirements of this royal decree.

2. The provisions of this royal decree shall apply without prejudice to the national and regional rules laid down to ensure the protection of persons and, in particular, workers using pressure equipment or assemblies of in question, provided that this does not entail modifications of the same in a form not specified in this royal decree.

3. It shall be permitted to present, on occasion of trade fairs, exhibitions or demonstrations and other similar events, pressure equipment or assemblies as defined in Article 1, which are not in conformity with the provisions of this royal decree, provided that clearly indicate, by means of a visible sign, their non-conformity and that, therefore, such equipment and assemblies cannot be placed on the market or put into service until they are in conformity. The demonstrations shall take, in accordance with the requirements laid down by the Autonomous Communities, appropriate security measures to ensure the protection and safety of persons.

Article 4. Technical requirements.

1. The pressure equipment listed below shall comply with the essential safety requirements set out in Annex I:

1.1 The containers, except those mentioned in paragraph 1.2, intended for:

(a) Gases, liquefied gases, gases dissolved under pressure, vapours and liquids whose vapour pressure at the maximum permissible temperature is greater than 0,5 bar at the normal atmospheric pressure (1.013 mbar), within the limits following:

a.1) For the fluids of Group 1 of Article 13, those with a volume (V) exceeding 1 litre (L) and the product of PS × V exceeding 25 bar litre, as well as those with a pressure PS of more than 200 bar (Table 1 of the Annex II).

a.2) For fluids in Group 2 of Article 13, which have a volume of more than 1 litre and whose product PS· × V is greater than 50 bar per litre, those with a pressure PS of more than 1,000 bar, as well as all fire extinguishers Portable containers and bottles for breathing apparatus (Table 2 of Annex II).

(b) Liquids whose vapour pressure at the maximum permissible temperature is less than or equal to 0,5 bar above the normal atmospheric pressure (1,013 mbar), within the following limits:

b.1) For fluids in Group 1 of Article 13, which have a volume of more than 1 litre and whose product PS × V is greater than 200 bar litre, as well as those with a pressure PS of more than 500 bar (Table 3 of Annex II).

b.2) For fluids in Group 2 of Article 13, those with a pressure PS of more than 10 bar and the product PS × V exceeding 10,000 bar per litre, as well as those with a pressure PS of more than 1,000 bar (Table 4 of Annex II).

1.2 Pressure equipment subjected to the action of a flame or a heat input representing a risk of overheating, intended for the production of steam or superheated water at temperatures exceeding 110 ° C, with a volume of more than 2 litres, as well as all pressure cookers (Table 5 of Annex II).

1.3 Piping for:

(a) Gases, liquefied gases, gases dissolved under pressure, vapours and liquids whose vapour pressure at the maximum permissible temperature is greater than 0,5 bar at the normal atmospheric pressure (1.013 mbar), within the limits following:

a.1) For group 1 fluids, if the DN is greater than 25 (Annex II, Table 6).

a.2) For group 2 fluids, if the DN is greater than 32 and the product PS × DN is greater than 1,000 bar (Table 7 of Annex II).

(b) Liquids whose vapour pressure at the maximum permissible temperature is less than or equal to 0,5 bar above the normal atmospheric pressure (1,013 mbar), within the following limits:

b.1) For group 1 fluids, if the DN is greater than 25 and the product PS × DN is greater than 2,000 bar (Table 8 of Annex II).

b.2) For group 2 fluids, if the PS is greater than 10 bar, the DN is greater than 200 and the product PS × DN is greater than 5,000 bar (Table 9 in Annex II).

1.4 Security accessories and pressure accessories intended for the equipment referred to in paragraphs 1.1, 1.2 and 1.3 inclusive, when such equipment is incorporated into a set.

2. The following sets defined in accordance with Article 2.6 and listed below which comprise at least one pressure equipment referred to in paragraph 1 of this Article shall comply with the essential safety requirements set out in Annex I.

2.1 Sets designed for the production of steam and water overheated at temperatures exceeding 110 ° C, which consist of at least one pressure equipment subjected to the action of the flame or another heat input representing a risk of overheating.

2.2 Sets other than those referred to in paragraph 2.1, when the manufacturer makes them available for placing on the market and putting into service as sets.

2.3 By way of derogation from paragraph 2, the sets intended for the production of hot water with a temperature of 110 ° C or less, fed manually with solid fuel, with a higher PS × V product 50 bar per litre shall comply with the essential safety requirements set out in paragraphs 2.10, 2.11 and 3.4 and paragraph 5 (a) and (d) of Annex I.

3. Pressure equipment and assemblies whose characteristics are less than or equal to the limits laid down respectively in paragraphs 1.1, 1.2 and 1.3 and in paragraph 2 of this Article shall be designed and manufactured in accordance with the good practice of the technique for use in a Member State of the European Union in order to ensure safety in its use. The pressure equipment and/or assemblies shall be attached to the appropriate and adequate instructions for use and shall bear the appropriate marks enabling the manufacturer or his authorised representative established in the European Union to be identified. Without prejudice to any other harmonisation legislation of the European Union providing for their placement, such pressure equipment and/or assemblies shall not bear the CE marking as defined in Article 17.

Article 5. Free movement.

1. The following shall not be prohibited, restricted or impeded because of the risks due to the pressure:

1.1 The placing on the market or putting into service, under the conditions laid down by the manufacturer, of the pressure equipment or the assemblies referred to in this royal decree and bearing the marking 'EC' means that they have been subject to an assessment of conformity in accordance with Article 14.

1.2 The placing on the market or putting into service of pressure equipment or assemblies complying with the provisions of Article 4.3.

2. The placing on the market or putting into service of pressure equipment or assemblies the conformity of which has been assessed by a user inspection body shall not be prohibited, restricted or impeded by the risks due to pressure. designated by another Member State, in accordance with Article 16 of Directive 2014 /68/EU of the European Parliament and of the Council of 15 May 2014 on the harmonisation of the laws of the Member States relating to the placing on the market of pressure equipment.

These pressure equipment or assemblies must comply with the following:

i) They will not be able to bear the CE marking.

(ii) They may be used only in establishments operated by the group of which the inspection body of the users has assessed their conformity. That group shall implement a common security policy with regard to the technical specifications relating to the design, manufacture, control, maintenance and use of such pressure equipment and assemblies.

3. In order to ensure the safe and correct use of pressure equipment and assemblies, the information set out in paragraphs 3.3 and 3.4 of Annex I shall be provided at least in Spanish.

CHAPTER II

Obligations of economic operators

Article 6. Obligations of manufacturers.

1. When placing on the market or using for their own purposes the pressure equipment or assemblies referred to in Article 4 (1) and (2), manufacturers shall ensure that they are designed and manufactured in accordance with the requirements laid down in Article 4 (1) and (2). When placing on the market or using for their own purposes the pressure equipment or assemblies referred to in Article 4.3, manufacturers shall ensure that they have been designed and/or set out in Annex I. manufactured in accordance with the good practice of the technique for use in a Member State of the Union European.

2. For the pressure equipment or assemblies referred to in Article 4 (1) and (2), manufacturers shall draw up the technical documentation referred to in Annex III and apply or mandate the application of the procedure for the assessment of the corresponding conformity referred to in Article 14. Where it has been demonstrated that the pressure equipment or assembly complies with the requirements applicable by the procedure referred to in this paragraph, manufacturers shall draw up an EU declaration of conformity and affix the CE marking.

3. Manufacturers shall keep the technical documentation and the EU declaration of conformity for at least 10 years after the introduction of the pressure equipment or the assemblies into the market.

4. Manufacturers shall ensure that the serial production maintains their conformity with this royal decree. Changes in the design or characteristics of the pressure equipment or assemblies and changes in the harmonised standards or other technical specifications according to which their conformity is declared shall be duly taken into account. Manufacturers shall test samples of the pressure equipment or sets placed on the market, investigate and, where appropriate, keep a record of the claims, pressure equipment and non-compliant assemblies and the recoveries of such equipment. equipment, and shall keep distributors informed of any such monitoring. Such records shall be made available to the competent administration.

5. Manufacturers shall ensure that their pressure equipment or assembly carries a number of type, batch or series or any other element allowing their identification or, if the size or nature of the equipment or the assembly does not allow it, that the Required information is contained in the packaging or in a document accompanying the equipment.

6. Manufacturers shall indicate their name, registered trade name or registered trade mark and the postal address of contact on the equipment under pressure or on the assembly or, where not possible, on the packaging or in a document accompanying the equipment or the set. The address shall indicate a single place where the manufacturer can be contacted. The contact details shall be at least in Spanish.

7. Manufacturers shall ensure that the pressure equipment or assemblies referred to in Article 4 (1) and (2) are accompanied by instructions and safety information in accordance with paragraphs 3.3 and 3.4 of Annex I, at least in Spanish. Such instructions and information relating to safety shall be clear, comprehensible and intelligible.

The manufacturers shall ensure that the pressure equipment or assemblies referred to in Article 4.3 are accompanied by instructions and safety information in accordance with Article 4.3 at least in Spanish. Such instructions and information relating to safety shall be clear, comprehensible and intelligible.

8. Manufacturers who consider or have reason to believe that a pressure equipment or assembly which they have placed on the market are not in conformity with this royal decree shall immediately take the necessary corrective measures to ensure that they are They may either withdraw them from the market or recall them, if appropriate. In addition, where pressure equipment or assemblies present a risk, manufacturers shall immediately inform the Autonomous Communities in which they have placed them on the market and provide details, in particular, of non-conformity and of the corrective measures taken.

9. In response to a reasoned request from the Autonomous Communities or the Ministry of Industry, Energy and Tourism, manufacturers shall provide all the information and documentation necessary to demonstrate the conformity of the equipment under pressure or assembly. with the present royal decree, at least in Spanish. Information and documentation may be provided on paper or in electronic form. At the request of the Autonomous Communities or the Ministry of Industry, Energy and Tourism, they shall cooperate in any action aimed at avoiding the risks presented by the pressure equipment or assemblies which they have placed on the market.

Article 7. Authorised representatives.

1. Manufacturers may, by means of a written mandate, designate an authorised representative. The obligations laid down in Article 6.1 and the obligation to draw up technical documentation referred to in Article 6.2 shall not form part of the mandate of the authorised representative.

2. The authorised representative shall carry out the tasks specified in the mandate received from the manufacturer. The command must allow the authorized representative to perform at least the following tasks:

2.1 Maintaining the EU declaration of conformity and the technical documentation at the disposal of the Autonomous Communities and the Ministry of Industry, Energy and Tourism for a minimum period of 10 years after the introduction of the equipment at pressure or set on the market.

2.2 In response to a reasoned request from the Autonomous Communities and the Ministry of Industry, Energy and Tourism, provide the necessary information and documentation to demonstrate the conformity of the pressure equipment or the set.

2.3 Co-operate with the Autonomous Communities and with the Ministry of Industry, Energy and Tourism, at their request, in any action aimed at eliminating the risks presented by the pressure equipment or the set object of its command.

Article 8. Obligations of importers.

1. Importers shall only place pressure equipment or compliant assemblies on the market.

2. Before the placing on the market of pressure equipment or assemblies referred to in Article 4 (1) and (2), importers shall ensure that the manufacturer has carried out the proper conformity assessment in accordance with Article 14. They shall ensure that the manufacturer has drawn up the technical documentation, that the pressure equipment or assemblies bear the CE marking, that they are accompanied by instructions and safety information in accordance with paragraphs 3.3. and 3.4 of Annex I and that the manufacturer has complied with the requirements set out in Article 6 (5) and (6

.

Before placing on the market the pressure equipment or assemblies referred to in Article 4.3 the importer shall ensure that the manufacturer has drawn up the technical documentation, that the equipment under pressure or (a) sets are accompanied by appropriate instructions for use and that the manufacturer has complied with the requirements set out in Article 6 (5) and (6

.

When an importer considers or has reason to believe that a pressure equipment or assembly does not meet the essential safety requirements set out in Annex I, it shall not market such equipment or assembly until such time as are compliant. In addition, where the pressure equipment or assembly presents a risk, the importer shall inform the manufacturer and the Autonomous Communities thereof.

3. Importers shall indicate their name, registered trade name or registered trade mark and the postal address of contact on the equipment under pressure or on the assembly or, where not possible, on the packaging or in a document accompanying the equipment or the set. The contact details shall be at least in Spanish.

4. Importers shall ensure that the pressure equipment or assemblies referred to in Article 4 (1) and (2) are accompanied by instructions and safety information in accordance with paragraphs 3.3 and 3.4 of Annex I, at least in the case of: Spanish.

The importers shall ensure that the pressure equipment or assemblies referred to in Article 4.3 are accompanied by instructions and safety information at least in Spanish.

5. Importers of pressure equipment or assemblies referred to in Article 4 (1) and (2) shall ensure that storage or transport conditions do not affect compliance with the essential safety requirements laid down in Article 4 (1) and (2). Annex I.

6. Where a risk is identified for the protection of the health and safety of consumers, importers shall test samples of the pressure equipment or the sets placed on the market, investigate and, where appropriate, keep a record of claims of pressure equipment or non-compliant assemblies and the recoveries of such equipment, and shall keep distributors informed of any such monitoring.

7. Importers, who consider or have reason to believe that a pressure equipment or a set which they have placed on the market is not in conformity with this royal decree, shall immediately take the necessary corrective measures to ensure that the equipment is in accordance with, or may withdraw or recall, if appropriate. In addition, where pressure equipment or assemblies present a risk, importers shall immediately inform the Autonomous Communities in which they have placed them on the market and provide details, in particular on non-conformity and the corrective measures taken.

8. Importers shall keep a copy of the EU declaration of conformity at the disposal of the Autonomous Communities and the Ministry of Industry for 10 years following the introduction of the pressure equipment or the whole on the market. Energy and Tourism, and ensure that, upon request, they receive a copy of the technical documentation.

9. In response to a reasoned request from the Autonomous Communities or from the Ministry of Industry, Energy and Tourism, importers shall provide the information and documentation necessary to demonstrate the conformity of the equipment under pressure or in the package, at least in Spanish. Information and documentation may be provided on paper or in electronic form. At the request of the Autonomous Communities or the Ministry of Industry, Energy and Tourism, they shall cooperate in any action aimed at avoiding the risks posed by pressure equipment or assemblies which have been placed on the market.

Article 9. Obligations of distributors.

1. When placing pressure equipment or assemblies on the market, distributors shall act with due diligence in relation to compliance with the requirements of this royal decree.

2. Before placing on the market any of the pressure equipment or assemblies referred to in Article 4 (1) and (2), distributors shall ensure that they bear the CE marking and are accompanied by the necessary documents. instructions and safety information in accordance with paragraphs 3.3 and 3.4 of Annex I, drawn up at least in Spanish, and that the manufacturer and the importer have complied with the requirements set out in Article 6 (5) and (6); and article 8.3, respectively.

When a distributor considers or has reason to believe that a pressure equipment or assembly does not meet the essential safety requirements set out in Annex I, it shall not market such equipment or assembly until such time as is compliant. In addition, where the pressure equipment or assembly presents a risk, the distributor shall inform the manufacturer, the importer and the Autonomous Communities in which they have placed the pressure equipment and the notifying authority.

Before placing on the market a pressure equipment or set listed in Article 4.3, distributors shall ensure that they are accompanied by appropriate instructions for use in at least Spanish, and that the manufacturer and the importer has complied with the requirements set out in Article 6 (5) and (6) and Article 8 (3) respectively.

3. Distributors of pressure equipment or assemblies referred to in Article 4 (1) and (2) shall ensure that storage or transport conditions do not affect compliance with the requirements set out in Annex I.

4. Distributors, who consider or have reason to believe that a pressure equipment or assembly which they have placed on the market is not in accordance with this royal decree, shall ensure that the corrective measures necessary to ensure that they are complied with are taken, they may be withdrawn from the market or recovered, if appropriate. In addition, where pressure equipment or assemblies present a risk, distributors shall immediately inform the Autonomous Communities in which they have placed them on the market and provide details, in particular on non-conformity and the corrective measures taken.

5. In response to a reasoned request from the Autonomous Communities or from the Ministry of Industry, Energy and Tourism, distributors shall provide the information and documentation necessary to demonstrate the conformity of the pressure equipment or the sets. Information and documentation may be provided on paper or in electronic form. At the request of the Autonomous Communities or the Ministry of Industry, Energy and Tourism, they shall cooperate in any action aimed at avoiding the risks posed by pressure equipment or assemblies which have been placed on the market.

Article 10. Cases where the obligations of the manufacturers apply to importers and distributors.

For the purposes of this Royal Decree, it shall be considered a manufacturer and shall therefore be subject to the obligations of the manufacturer in accordance with Article 6, an importer or distributor who introduces pressure equipment or sets on the market under its name or brand name or modify pressure equipment that has already been placed on the market, so that its compliance with the requirements of this royal decree may be affected.

Article 11. Identification of economic operators.

1. At the request of the Autonomous Communities or the Ministry of Industry, Energy and Tourism, economic operators shall identify:

a) Any economic agent who has supplied them with a pressure equipment or a set.

b) Any economic operator to whom they have supplied a pressure equipment or a set.

2. Economic operators shall be able to provide such information for at least 10 years after they have been supplied with pressure equipment or assembly and for 10 years after they have supplied the pressure equipment or the equipment. set.

CHAPTER III

Conformity and classification of pressure equipment and assemblies

Article 12. Presumption of conformity.

1. Pressure equipment or assemblies referred to in Article 4 (1) and (2) shall be presumed to be in conformity with harmonised standards or parts of standards the references of which have been published in the Official Journal of the European Union. They comply with the essential safety requirements of those standards or parts thereof, as set out in Annex I.

2. Where the materials used in the manufacture of pressure equipment or assemblies are in conformity with the European materials approvals and their references have been published in the Official Journal of the European Union in accordance with the Article 15 (4) shall be presumed to be in accordance with the applicable essential safety requirements set out in Annex I.

Article 13. Classification of the pressure equipment.

1. The pressure equipment referred to in Article 4.1 shall be classified by category in accordance with Annex II, on a growing scale of degree of danger.

For the purposes of this classification, fluids will be divided into the following two groups:

1.1 Group 1 consisting of substances and mixtures, as defined in points 7 and 8 of Article 2 of Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures and amending and repealing Directives 67 /548/EEC and 1999 /45/EC and amending Regulation (EC) No 1907/2006, which are classified as dangerous according to the following classes of physical hazards and for the health laid down in Parts 2 and 3 of Annex I to that Regulation:

a) Unstable explosives or divisions 1.1, 1.2, 1.3, 1.4 and 1.5.

b) flammable Gases of categories 1 and 2.

c) Category 1-fighting Gases.

(d) flammable liquids of categories 1 and 2.

e) flammable liquids in category 3 where the maximum permissible temperature is higher than the flash point.

F) Flammable solids of categories 1 and 2.

g) Self-reactive substances and mixtures of types A to F.

h) Pirophoric liquids of category 1.

i) Pirophoric Solid of Category 1.

j) Substances and mixtures which, in contact with water, release flammable gases from categories 1, 2 and 3.

k) Oxidising liquids of categories 1, 2 and 3.

(l) Oxidising solids of categories 1, 2 and 3.

m) Organic Peroxides of types A to F.

n) Acute oral toxicity of categories 1 and 2.

o) Acute dermal toxicity of categories 1 and 2.

p) Acute inhalation toxicity of categories 1, 2 and 3.

q) Specific toxicity in certain organs (single exposure) of category 1.

Group 1 also includes substances and mixtures contained in pressure equipment with a maximum permissible temperature TS that exceeds the point of inflammation of the fluid.

1.2 Group 2, comprising the substances and mixtures not referred to in paragraph 1.1

2. When a container is made up of several chambers, the container shall be classified in the highest category of each individual chamber. When a chamber contains several fluids, the classification will be performed according to the fluid that requires the highest risk category.

Article 14. Assessment of compliance.

1. The conformity assessment procedures to be applied to a pressure equipment shall be determined by the category, established in accordance with Article 13, in which the equipment is classified.

2. The conformity assessment procedures to be applied in the different categories are as follows:

a) Category I:

Module A.

b) Category II:

Module A2.

Module D1.

Module E1.

c) Category III:

B modules (design type) + D.

B Modules (design type) + F.

B modules (production type) + E.

B modules (production type) + C2.

H. Module

d) Category IV:

B modules (production type) + D.

B modules (production type) + F.

G. Module

Module H1.

Compliance assessment procedures are set out in Annex III.

3. Pressure equipment shall be subjected to one of the conformity assessment procedures, at the choice of the manufacturer, corresponding to the category to which the equipment belongs. The manufacturer may also, if he so wishes, apply one of the procedures laid down for the higher category, provided that it exists.

4. In the framework of the quality assurance procedure for pressure equipment classified in categories III and IV, as referred to in the first subparagraph of Article 4 (1) (a), Article 4 (1) (b) and Article 4, paragraph 1.2, the notified body of control, when carrying out unannounced visits, shall take a sample of the equipment at the manufacturing or storage site, in order to carry out, or send out, the final assessment referred to in the Paragraph 3.2 of Annex I. To this end, the manufacturer shall inform the notified body of control of the planned plan of production. The notified inspection body shall carry out at least two visits during the first year of manufacture and shall fix the frequency of subsequent visits in accordance with the criteria laid down in paragraph 4.4 of the modules D, E and H and the paragraph 5, paragraph 4, of module H1.

5. In the case of the manufacture of a single specimen of pressure vessels and equipment classified in category III, as referred to in paragraph (b) of Article 4 (1), in accordance with the procedure of module H, the control body the notified body shall carry out the final assessment referred to in paragraph 3.2 of Annex I to each unit. To this end, the manufacturer shall communicate the planned production plan to the notified body of control.

6. The sets referred to in Article 4.2 shall be subject to a general conformity assessment procedure which shall include the following assessments:

(a) The assessment of each of the pressure equipment forming part of the assembly and referred to in Article 4.1, where they have not previously been submitted to a conformity assessment procedure and to a 'CE' separately marked 'EC'; the assessment procedure shall be determined by the category of each of the equipment.

(b) The assessment of the integration of the different elements of the set in accordance with paragraphs 2.3, 2.8 and 2.9 of Annex I, which shall be determined by the highest category of the equipment concerned, without taking into account the applicable to security accessories.

(c) The assessment of the protection of the whole against the overshooting of the permissible limits of service in accordance with paragraphs 2.10 and 3.2.3 of Annex I, which shall be carried out on the basis of the highest category of the equipment to be protected.

7. By way of derogation from paragraphs 1 to 6 of this Article, the Autonomous Communities may permit, where justified, the placing on the market and putting into service on the national territory of the pressure and joint equipment. individual referred to in Article 2 for which the procedures laid down in paragraphs 1 to 6 of this Article have not been applied and whose use is of interest to experimentation.

8. Documents and correspondence relating to conformity assessment procedures shall be drawn up at least in Spanish.

Article 15. European approval of materials.

1. The notified inspection body may issue the European approval of materials, at the request of one or more manufacturers of materials or equipment. For this purpose, it shall define and carry out, or have carried out, appropriate examinations and tests to certify the conformity of the types of material with the corresponding requirements of this royal decree. In the case of recognised safe use materials before 29 November 1999, existing data shall be taken into account in order to certify that conformity.

2. Before issuing European material approval, the notified control body shall forward the relevant information to the Member States and to the European Commission. The observations submitted by the Member States or the European Commission within a period of three months shall be taken into account in order to issue the European approval of materials.

3. The notified inspection body shall forward a copy of the European approval of pressure equipment to the Member States, the other notified bodies and the European Commission. The list of European material approvals shall be that which is published and updated in the Official Journal of the European Union.

4. Where the European material approval complies with the requirements set out in Annex I, the references of that approval, as well as an updated list of these approvals, shall be published in the Official Journal of the European Union, the European Commission may decide, even after publication if it considers that the requirements and at the request of a Member State are not met, the withdrawal of such approval.

5. The notified inspection body may withdraw such approval provided it finds that it should not have been issued or that the type of material is regulated by a harmonised standard. It shall immediately inform the Member States, the other notified bodies and the European Commission of any withdrawal of approval.

Article 16. EU declaration of conformity.

1. The EU declaration of conformity indicates compliance with the essential safety requirements set out in Annex I.

2. The EU declaration of conformity shall be made in accordance with the model set out in Annex IV, shall contain the elements specified in the relevant modules set out in Annex III and shall be kept up to date. This declaration will come at least in Spanish, for those pressure equipment or assemblies that are introduced or marketed in Spain.

3. Where a pressure equipment or assembly is subject to more than one of the rules and acts of the European Union requiring an EU declaration of conformity, a single EU declaration of conformity shall be drawn up containing the identification of the rules and corresponding European acts and their publication references.

Article 17. CE marking.

1. The CE marking shall be subject to the general principles of Article 30 of Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 laying down the requirements for accreditation and market surveillance concerning the placing on the market of the products and repealing Regulation (EEC) No 339/93.

2. The CE marking shall be affixed visibly, clearly legible and indelible:

a) On each pressure equipment referred to in Article 4.1, or on its nameplate.

(b) For each set referred to in Article 4.2, complete or in a state that permits final verification, as described in paragraph 3.2 of Annex I.

3. Where the affixing of the CE marking is not possible or cannot be ensured due to the nature of the equipment or assembly, it shall be affixed to the packaging and to the accompanying documents. The equipment or set provided for in paragraphs (a) and (b) of paragraph 2 of this Article shall be complete or in a state which allows for the final assessment as described in paragraph 3.2 of Annex I.

4. It shall not be necessary to affix the CE marking on each of the individual pressure equipment which consists of a set of those referred to in Article 4.2, as they shall retain the individual pressure equipment when incorporated into the assembly.

5. The CE marking shall be affixed before the pressure equipment or assembly is placed on the market.

6. The CE marking shall be followed by the identification number of the notified body of control when it participates in the production control phase. The identification number of the notified control body shall be affixed by the body itself or, following the instructions of the body, by the manufacturer or his authorised representative.

7. The CE marking and, where appropriate, the identification number referred to in paragraph 6, may be followed by any other mark indicating a special risk or use.

8. The Autonomous Communities shall ensure the correct application of the arrangements governing the CE marking and shall take appropriate measures in the event of improper use of the system, the safeguard procedure laid down in Article 32 being applicable to the Community. failure to comply with those measures.

CHAPTER IV

Notification of control bodies and independent entities

Article 18. Independent bodies and entities subject to notification.

1. The control bodies, which comply with the provisions of Royal Decree 2200/1995 of 28 December 1995, approving the Regulation of the infrastructure for industrial quality and safety and Article 21 of this royal decree, may be notified to the European Commission and the other Member States to carry out the conformity assessment tasks referred to in Articles 14 and 15.

2. Independent entities complying with the provisions of Royal Decree 2200/1995 of 28 December 1995 and Article 21 of this royal decree may be notified to the European Commission and to the other Member States for the purpose of carrying out those tasks referred to in paragraphs 3.1.2 and 3.1.3 of Annex I.

Article 19. Notifying authority.

The Ministry of Industry, Energy and Tourism is designated as notifying authority, which shall be responsible for the establishment and implementation of the procedures necessary for the assessment, notification and monitoring of the control bodies and independent entities, taking into account also compliance with Article 22, on subsidiaries and subcontracting.

Article 20. Reporting obligation of the notifying authority.

At the request of the European Commission, the Ministry of Industry, Energy and Tourism will inform the European Commission of the procedures for the evaluation, notification and monitoring of the control bodies and independent entities. notified.

Article 21. Requirements of the notified control bodies and of the independent entities.

1. The control bodies notified by the Ministry of Industry, Energy and Tourism shall comply with the provisions of Royal Decree 2200/1995 of 28 December 1995, and in particular the following requirements:

(a) The control body shall have legal personality.

(b) The control body shall be independent of the organisation or team under pressure or set which it assesses. This may be a body belonging to a business association or a professional federation representing the undertakings involved in the design, manufacture, supply, assembly, use or maintenance of the equipment concerned. pressure or the sets it evaluates, provided that its independence and the absence of conflicts of interest are demonstrated.

c) The control body, its top management and the staff responsible for carrying out the conformity assessment tasks shall not be the designer, the manufacturer, the supplier, the installer, the buyer, the owner, the the user or the person in charge of the maintenance of the pressure equipment or the assemblies they evaluate, or the representative of any of them. This shall not prevent the use of the pressure equipment or the assessed assemblies that are necessary for the conformity assessment activities.

(d) The control body, its top management and the personnel responsible for carrying out the conformity assessment tasks shall not directly intervene in the design, manufacture or construction, the placing on the market, the installation, use or maintenance of these equipment under pressure or assemblies, nor shall they represent the parties involved in these activities. They shall not engage in any activity that may conflict with their independence of criteria or their integrity in relation to the conformity assessment activities for which they are notified. This shall apply in particular to consultancy services.

(e) Control bodies shall ensure that the activities of their subsidiaries or subcontractors do not affect the confidentiality, objectivity and impartiality of their conformity assessment activities.

f) the control bodies and their staff shall carry out the activities of conformity assessment with the highest level of professional integrity and with the required technical competence for the specific field, and shall be free of any pressure or incentive, in particular of a financial nature, which may influence its assessment or the outcome of its conformity assessment activities, in particular that which may be exercised by persons or groups of persons who have some interest in the results of these activities.

g) The control body shall be able to perform all the conformity assessment tasks assigned to it in accordance with the provisions of this royal decree and for which it has been notified, independently to perform the tasks of the body itself or be carried out on its behalf and under its responsibility. At all times, in respect of each conformity assessment procedure and for each type or category of pressure equipment for which it has been notified, the conformity assessment body shall have the following:

1.) Of the required personnel with sufficient technical knowledge and experience to perform the conformity assessment tasks.

2. °) Of the descriptions of the procedures under which conformity assessment is carried out, ensuring the transparency and the possibility of reproduction of these procedures, and of strategies and appropriate procedures to distinguish between tasks carried out as a control body and any other activity.

3.) Procedures for carrying out their activities taking due account of the size of the companies, the sector in which they operate, their structure, the degree of complexity of the technology of the product concerned and whether the production process is serial.

(h) The control body shall have the necessary means to perform the technical and administrative tasks related to conformity assessment activities appropriately and shall have access to the entire equipment or the facilities that you need.

The personnel performing the compliance assessment tasks will have:

1.) Good technical and professional training to perform all conformity assessment activities for which the control body has been notified.

2. º) A satisfactory knowledge of the requirements of the assessments it makes and the authority necessary to carry them out.

3. °) A proper understanding and understanding of the essential safety requirements set out in Annex I, the applicable harmonised standards and the relevant provisions of the harmonisation legislation European Union as well as national legislation.

4. º) The capacity required for the preparation of the certificates, documents and reports showing that the evaluations have been carried out.

i) Guarantee the impartiality of the body, its top management and the staff responsible for carrying out the conformity assessment tasks.

The remuneration of the top management and the staff responsible for carrying out the tasks of conformity assessment of a body of control body shall not depend on the number of assessments carried out or on the the results of such assessments.

(j) The control body shall enter into civil liability insurance, guarantee or other equivalent guarantee covering civil liability.

(k) The staff of the inspection body shall observe the professional secrecy concerning all the information collected in the course of their duties, except in respect of the competent authorities and shall protect the rights of the property.

l) The control body shall participate in the relevant standardisation activities and the activities of the coordination group of the notified body established in accordance with the harmonisation legislation of the European Union (a) to ensure that the staff responsible for carrying out the conformity assessment tasks are informed of this, and shall apply, in the manner of general guidelines, the administrative decisions and documents resulting from the the work of the group.

2. The independent entities notified by the Ministry of Industry, Energy and Tourism shall comply with the provisions of Royal Decree 2200/1995 of 28 December 1995, and in particular the requirements referred to in paragraph 1 for the control.

Article 22. Subsidiaries and subcontracting.

1. The notified control body and the independent entities may subcontract in the field of this royal decree specific tasks related to the conformity assessment or the use of a subsidiary and shall ensure that the subcontractor or the Subsidiary complies with the requirements of Article 21.

2. The notified control bodies and the independent entities shall be fully responsible for the tasks performed by the subcontractors or the subsidiaries, irrespective of where they are based.

3. Activities may only be subcontracted or carried out in a subsidiary with the consent of the client.

4. The notified control bodies and the independent entities shall keep at the disposal of the Autonomous Communities and the Ministry of Industry, Energy and Tourism the documents supporting the qualification of the subcontractor or the subsidiary. as the work carried out in accordance with Article 14, Article 15, or paragraphs 3.1.2 and 3.1.3 of Annex I.

Article 23. Request for notification.

1. The control bodies and independent entities shall submit a request for notification to the competent authority of the Autonomous Community where it has been enabled as set out in Royal Decree 2200/1995 of 28 December.

2. This application shall be accompanied by the following documentation: a description of its activities, of the conformity assessment module (s) and of the pressure equipment for which it is considered competent, as well as a copy of the relevant certificate of accreditation issued by the National Accreditation Body (ENAC) and the supporting documentation of having an insurance, guarantee or other equivalent financial guarantee covering its civil liability, as established in the Royal Decree 2200/1995 of 28 December 1995. The Autonomous Community shall register the control body in the Integrated Industrial Register.

3. The Autonomous Communities shall communicate to the Ministry of Industry, Energy and Tourism, where appropriate, this request, together with the documents described in the preceding paragraph, for notification to the European Commission and the other States. members.

Article 24. Notification to the European Commission and other Member States.

1. The Ministry of Industry, Energy and Tourism shall notify the European Commission and the other Member States by means of the electronic notification system and shall report any relevant changes after the notification.

2. The notification shall include information on the conformity assessment activities, the module or the conformity assessment modules, the pressure equipment in question and the corresponding accreditation certificate.

3. The control body and the independent entity may carry out their activities provided that the Commission and the other Member States do not object within two weeks of the notification. After this deadline, it will be considered a notified control body or an independent entity, only for the purposes of this royal decree.

4. Each notified control body and each independent entity, even when notified under different European Union rules and legal acts, shall have an identification number assigned by the European Commission, which shall be published in a list together with the relevant independent entity or notified body of control, and the activities for which it has been notified.

Article 25. Changes to the notification.

1. If it is found that a notified control body or an independent entity no longer meets the requirements laid down in Article 21, or is not fulfilling its obligations, the Ministry of Industry, Energy and Tourism may restrict, suspend or withdraw the notification, as appropriate, depending on the seriousness of the non-compliance with the requirements or obligations, and inform the European Commission and the other Member States.

2. In the event of withdrawal, restriction or suspension of the notification or the notified body or the independent entity having ceased its activity, the competent authority of the Autonomous Community in which it carries out its activity shall take the measures appropriate to ensure that the files of that body or entity are dealt with by another notified body or other independent entity, as appropriate or made available to the Autonomous Communities where they so request.

3. The Ministry of Industry, Energy and Tourism will also provide the European Commission with the necessary information regarding competition, compliance with the requirements and the responsibilities assigned to the European Commission. the notified control or the independent entity, for verification and, where appropriate, implementation of the corrective measures.

Article 26. Obligations of the notified control bodies and of the independent entities.

In addition to the provisions of Royal Decree 2200/1995 of 28 December 1995, the notified control bodies and independent entities shall comply with the following:

1. The notified control bodies shall carry out conformity assessments in accordance with Article 14 and Article 15 and the independent entities shall carry out the tasks referred to in paragraphs 3.1.2 and 3.1.3

Annex I.

2. They shall carry out their activities taking due account of the size of the undertakings, the sector in which they operate, their structure, the degree of complexity of the pressure equipment technology or the whole concerned and whether the production process is in string.

However, they will respect the degree of rigour and the level of protection required for the pressure equipment to meet the requirements of this royal decree.

3. If it is found that the manufacturer does not meet the essential safety requirements set out in Annex I or the relevant harmonised standards or other technical specifications, the manufacturer shall be required to take appropriate corrective action and the certificate of compliance shall not be issued.

4. If, in the course of the follow-up of the conformity in succession to the issue of the certificate, it is found that the pressure equipment is no longer in conformity, it shall notify the manufacturer of the deficiencies or anomalies detected and shall require the manufacturer to take the appropriate corrective measures indicating the time limits for which they are to be remedied and, if necessary, suspend or withdraw their certificate, bringing it to the attention of the competent authority in the field of industry in the Autonomous Community, in which territorial scope develops its activity.

5. If corrective measures are not taken or the measures do not have the required effect, any certificate shall be restricted, suspended or withdrawn, as the case may be, in the knowledge of the competent authority in the field of industry in the Autonomous Community, whose territorial scope develops its activity.

Article 27. Claim against the decisions of the notified control bodies and of the independent entities.

When a notified control body or an independent entity issues a protocol, minutes, report or certification with a negative result of compliance with the regulatory requirements, the data subject may claim its failure to comply with it before the body itself or the entity and, in the event of failure to reach an agreement, before the competent authority of the Autonomous Community in which it radiating for the purposes of Article 16.2 of Law 21/1992 of 16 July 1992, Industry.

Article 28. Reporting obligation for notified control bodies and independent entities.

1. Notified control bodies and independent entities shall inform the competent authority in the field of industrial safety in the Autonomous Community:

(a) Any refusal, restriction, suspension or withdrawal of their certificates.

b) Any circumstances that affect the scope or conditions of the notification.

(c) Any request for information on the conformity assessment activities that they have received from the market surveillance point of view.

2. Upon request by the competent industrial safety authority of the Autonomous Community, they shall report on the conformity assessment activities carried out within the scope of their notification and on any other activity carried out, including cross-border activities and subcontracting.

3. They shall provide the other notified control bodies and independent entities with relevant information on issues related to negative results and, upon request, that information related to positive results of the assessment of compliance.

Article 29. Coordination of the notified control bodies and independent entities.

The notified control bodies and independent entities shall participate in the relevant standardisation activities and the activities of the group or coordination and cooperation groups of bodies notified directly or by means of designated representatives, shall ensure that their assessment personnel are informed of this, and shall apply in the form of general guidelines the decisions and administrative documents resulting from the work of the group.

CHAPTER V

Market surveillance of the European Union, control of pressure equipment and assemblies entering the European Union market and safeguard procedure of the European Union

Article 30. Market surveillance and control of equipment and pressure assemblies.

Article 15 (3) of this Royal Decree and Articles 16 to 29 of Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 shall apply to pressure equipment and assemblies to be referred to in Article 1 of this royal decree.

In accordance with the provisions of Law 21/1992, of 16 July, of Industry, without prejudice to the actions of inspection and control that the Autonomous Communities competent in the field develop in their territorial field, the The Ministry of Industry, Energy and Tourism may promote national plans and campaigns to check the safety conditions of the equipment and assemblies referred to in Article 1 of this royal decree.

Article 31. Pressure equipment or assemblies presenting a risk.

1. Where there is sufficient reason to believe that a pressure equipment or a set poses a risk to the health or safety of persons, or to domestic animals or property, if it has not been carried out, a assessment of the pressure equipment or set in question, taking into account all relevant requirements set out in this Royal Decree. To this end, the relevant economic operators shall cooperate in accordance with the needs of the Autonomous Communities and with the Ministry of Industry, Energy and Tourism.

When, in the course of the assessment mentioned above, it is noted that the pressure equipment or the assembly does not meet the requirements laid down in this royal decree, the Autonomous Communities shall without delay request the economic operator it is appropriate to take all appropriate corrective measures to adapt the equipment under pressure or the set to the requirements, to withdraw it from the market or to recall it within a reasonable time, proportionate to the nature of the risk, prescribe.

The corresponding notified control body will be reported accordingly.

The provisions of Article 21 of Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 shall apply to the measures referred to in this paragraph.

2. Where the non-compliance is deemed not to be limited to the national territory, the Ministry of Industry, Energy and Tourism shall inform the European Commission and the other Member States of the results of the assessment and of the measures they have requested. to the economic agent you adopt.

3. The economic operator shall ensure that the relevant corrective measures are taken in relation to all the pressure equipment and sets concerned which it has placed on the market throughout the European Union.

4. If the economic operator does not take appropriate corrective action, the Autonomous Communities shall take appropriate provisional measures to prohibit or restrict the marketing of equipment or assemblies on the domestic market, to withdraw them from that market. market, or retrieve them.

The Autonomous Communities concerned shall inform the Ministry of Industry, Energy and Tourism of the provisional measures taken, and the latter shall inform the European Commission and the other Member States of such measures, which in the event of They will be able to object to them.

5. The information referred to in paragraph 4 shall include all available details, in particular the data necessary for the identification of the pressure equipment or the non-compliant set, the origin of the pressure equipment or the assembly, the nature of the equipment. the alleged non-compliance and the risk involved, and the nature and duration of the national measures taken, as well as the arguments put forward by the relevant economic operator.

In particular, it will be indicated if the lack of compliance is due to one of the following reasons:

(a) The equipment or assembly does not meet the requirements related to the health or safety of persons, the protection of domestic animals or property.

(b) There are deficiencies in the harmonised standards referred to in Article 12 which attribute a presumption of conformity.

6. If, within three months of receipt of the information referred to in paragraph 4, no objection has been raised by any Member State or the European Commission to an interim measure, the measure shall be deemed to be justified.

Article 32. The safeguard procedure of the European Union.

1. If, once the corrective measures referred to in Article 31.3 and 4 have been taken, objections are raised against them, or if the European Commission considers that such measures are contrary to European Union law, it shall apply. the safeguard procedure of the European Union.

2. If, as a result of the application of the safeguard procedure, the European Commission considers the national measures justified, the Ministry of Industry, Energy and Tourism and the Autonomous Communities shall ensure that such measures are complied with. measures and for the non-compliant equipment or assembly to be withdrawn from the market, and the European Commission will be informed of this. If the national measure is not considered justified, that measure shall be withdrawn.

3. Where the national measure is considered to be justified and the non-conformity of the equipment or assembly is attributed to a deficiency of the harmonised standards referred to in Article 31.5.b) of this royal decree, the procedure laid down shall apply. in Article 11 of Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation, amending Council Directives 89 /686/EEC and 93 /15/EEC and the Directives 94 /9/EC, 94 /25/EC, 95 /16/EC, 97 /23/EC, 98 /34/EC, 2004 /22/EC, 2007 /23/EC, 2009 /23/EC and 2009 /105/EC European Parliament and the Council and repealing Council Decision 87 /95/EEC and Decision No 1673 /2006/EC of the European Parliament and of the Council.

Article 33. Pressure equipment or compliant assemblies presenting a risk.

1. If, after an assessment in accordance with Article 31.1, a pressure equipment or assembly is found to be at risk for the health or safety of the animals, although in accordance with the present royal decree, it is domestic or property, the relevant economic operator shall be required to take all appropriate measures to ensure that the equipment or assembly concerned does not present that risk when it is placed on the market or to withdraw it from the market or to be recovered within a reasonable time, proportionate to the nature of the risk to be determined.

2. The economic operator shall ensure that the necessary corrective measures are taken in relation to all the equipment or sets concerned which it has placed on the market throughout the European Union.

3. The Ministry of Industry, Energy and Tourism shall immediately inform the European Commission for its assessment and decision and the other Member States. The information provided shall include all available details, in particular the data necessary to identify the equipment or set in question and determine its origin, the supply chain of the equipment or assembly, the nature of the risk the nature and duration of the measures taken.

Article 34. Formal non-compliance.

1. Without prejudice to Article 31, if one of the following situations is found, the relevant economic operator shall be required to remedy the lack of conformity in question:

(a) The CE marking has been affixed in violation of Article 30 of Regulation (EC) No 765/2008 of 9 July 2008 or Article 17 of this royal decree, or the CE marking has not been affixed.

(b) The identification number of the notified body participating in the production control phase has been placed in breach of Article 17, or has not been placed.

(c) The markings and labelling referred to in paragraph 3.3 of Annex I have not been affixed or have been placed in breach of Article 17 or point 3.3 of Annex I.

d) The absence of the EU declaration of conformity or, the EU declaration of conformity has not been correctly established.

e) The technical documentation is not available or incomplete.

(f) The information referred to in Article 6.6 or in Article 8.3 is false or incomplete.

g) Any other administrative requirements set out in Article 6 or Article 8 are not met.

2. If the lack of conformity referred to in paragraph 1 persists, all appropriate measures shall be taken to restrict or prohibit the marketing of the equipment or assembly or to ensure that it is recovered or withdrawn from the market.

CHAPTER VI

Sanctioning Regime

Article 35. Sanctioning regime.

The breaches of the provisions of Title V of Law 21/1992, of July 16, of Industry will apply to the non-compliance with the provisions of this royal decree.

Additional disposition first. Putting into service.

For the putting into service of the pressure equipment and the sets of this royal decree, the procedures established for the effect in Royal Decree 2060/2008, of December 12, for which the Regulation of pressure equipment and its accompanying technical instructions.

Additional provision second. References to Royal Decree 769/1999 of 7 May.

The references, in the legal, regulatory and administrative provisions in force, to Royal Decree 769/1999 of 7 May 1999 laying down detailed rules for the application of the Directive of the European Parliament and of the Council Council, 97 /23/EC, concerning pressure equipment and amending Royal Decree 1244/1979, of 4 April, which approved the Regulation of pressure equipment, will be understood to be made to the present royal decree.

First transient disposition. Transitional period for the placing on the market and putting into service of pressure equipment and assemblies complying with the provisions of Royal Decree 769/1999 of 7 May 1999.

1. Pressure equipment and assemblies complying with the provisions of Royal Decree 769/1999 of 7 May 1999 laying down detailed rules for the implementation of the Directive of the European Parliament and of the Council, 97 /23/EC, on the Under the terms of Article 9 of Royal Decree No 769/1999 of 7 May 2016, the Royal Decree No 1244/1979 of 4 April 1979, which approved the Regulation on pressure equipment, may continue to be placed on the market until 19 July 2016. where the case shall be complied with in accordance with Article 13 of this royal decree from the date of entry in force. The putting into service of such pressure equipment and assemblies may be carried out after that date has been exceeded.

2. Certificates and decisions issued by control bodies pursuant to Royal Decree 769/1999 of 7 May shall be valid in accordance with this royal decree.

Second transient disposition. Regulations applicable to pressure equipment or assemblies put into service prior to the entry into force of this royal decree.

The pressure equipment and assemblies, whose commissioning would have been carried out prior to the entry into force of this royal decree, will continue to be governed by the technical prescriptions that have been application up to that date.

Single repeal provision. Regulatory repeal.

1. Royal Decree 769/1999 of 7 May 1999 laying down detailed rules for the application of the Directive of the European Parliament and of the Council, 97 /23/EC, on pressure equipment and amending Royal Decree 1244/1979 of 4 December 1999 is hereby repealed. April, which approved the Regulation of pressure equipment, according to the dates of entry into force of this royal decree that are determined in the final disposition fifth.

2. In general, likewise, the provisions of equal or lower rank are repealed as set out in this royal decree.

Final disposition first. Competence title.

This royal decree is dictated by the provisions of Article 149.1.13. of the Constitution, which attributes to the State exclusive competences on the basis and coordination of the general planning of economic activity.

Final disposition second. Incorporation of European Union law.

This royal decree incorporates into Spanish law Directive 2014 /68/EU of the European Parliament and of the Council of 15 May 2014 on the harmonisation of the laws of the Member States relating to the marketing of pressure equipment.

Final disposition third. Regulatory development.

The Minister of Industry, Energy and Tourism is empowered to dictate the rules for the development of this royal decree.

Final disposition fourth. Enablement for updating the technical content of the annexes to this royal decree.

The Minister of Industry, Energy and Tourism is authorized to update by order the technical content of the annexes of this royal decree, in order to keep it permanently adapted to the progress of the technique, as well as to the rules of law of the European Union or other international bodies.

Final disposition fifth. Entry into force.

Article 13 of this royal decree shall enter into force on the day following that of its publication in the "Official Gazette of the State" and the other articles as of July 19, 2016.

Given in Madrid, on July 24, 2015.

FELIPE R.

The Minister of Industry, Energy and Tourism,

JOSE MANUEL SORIA LOPEZ

ANNEX I

Essential security requirements

A. General requirements

0. Preliminary observations

1. The obligations established by the essential safety requirements set out in this Annex in respect of pressure equipment shall also apply to assemblies where the relevant risk exists.

2. The essential safety requirements contained in the Directive are mandatory. The obligations arising from such essential safety requirements shall only apply where the pressure equipment in question carries the relevant risk when used in the reasonably foreseeable conditions by the manufacturer.

3. The manufacturer shall be obliged to carry out an assessment of the risks and hazards to determine those which apply to his equipment due to the pressure; they shall then proceed to design and manufacture in the light of the assessment.

4. The essential safety requirements shall be interpreted and applied in such a way as to take into account the state of the art and the practice at the time of design and manufacture, as well as the technical and economic considerations which are compatible. with a high degree of health and safety protection.

1. Generalities

1.1 Pressure equipment shall be designed, manufactured, controlled and, where appropriate, equipped and installed in such a way as to ensure the safety of the equipment if they are put into service in accordance with the instructions of the manufacturer or in reasonably foreseeable conditions.

1.2 To opt for the most appropriate solutions, the manufacturer shall apply the principles set out below and in the same order:

a) Remove or reduce risks as much as reasonably possible.

b) Apply appropriate protection measures against risks that cannot be removed.

(c) Inform, where appropriate, users of the residual risks and indicate whether appropriate special measures need to be taken to mitigate the risks at the time of installation or use.

1.3 In the event that the possibility of misuse is known or can be clearly foreseen, the pressure equipment shall be designed to prevent the risks arising from such use or, if this is not possible, to be indicated in a manner appropriate that the pressure equipment should not be used in that way.

2. Design

2.1 Generalities.

Pressure equipment will be properly designed taking into account all relevant factors to ensure the safety of the equipment throughout its intended life.

The design shall include appropriate safety coefficients which shall be based on general methods of constancy that use relevant safety margins to consistently prevent any type of failure.

2.2 Design for proper resistance.

2.2.1 Pressure equipment shall be designed to withstand the charges for the intended use, as well as for other reasonably foreseeable operating conditions. In particular, the following factors shall be taken into account:

a) The outside pressure and the inside pressure.

b) The ambient temperature and operating temperature.

c) The static pressure and the mass of the content under test and operating conditions.

d) Charges due to traffic, wind and earthquakes.

e) The forces and reaction moments derived from the supports, the mounting devices, the pipes, etc.

f) Corrosion and erosion, fatigue, etc.

g) Decomposition of unstable fluids.

Different loads that can occur at the same time will be considered considering the likelihood of their concurrent event.

2.2.2 The design for appropriate resistance will be based on any of the following considerations:

As a general rule, a method of calculation, as specified in paragraph 2.2.3, completed, if necessary, with an experimental method of design as specified in paragraph 2.2.4.

An experimental method of design without calculation, as specified in paragraph 2.2.4, in the case where the product of the maximum allowable pressure PS by volume V is less than 6,000 barrelling L, or the product PSNID DN is lower to 3,000 bar.

2.2.3 Method of calculation.

a) Containment of pressure and other loads.

The permissible stresses in the pressure equipment shall be limited according to the reasonably foreseeable failures under operating conditions. To this end, security factors shall be applied which allow the removal of any doubt arising from the manufacture, actual conditions of use, stresses, models of calculation or the properties and behaviour of the material.

These calculation methods shall provide sufficient safety margins in accordance, where appropriate, with the provisions of paragraph 7.

The above may be fulfilled by applying, in addition to another method or in combination with, if necessary, the most appropriate method of those listed below:

Layout by formulas.

Design by analysis.

Design by mechanics of breakage.

b) Resistance.

The appropriate design calculations shall be used to determine the strength of the pressure equipment in question.

In particular:

The calculation pressures shall not be lower than the maximum allowable pressures and shall take into account the static and dynamic fluid pressures as well as the decomposition of the unstable fluids. If a container is divided into individual pressure containment chambers, the thickness of the dividing wall shall be calculated on the basis of the maximum possible chamber pressure in relation to the minimum possible pressure in the chamber. adjacent.

Calculation temperatures should allow adequate safety margins.

The design shall take due account of all possible combinations of temperature and pressure that may occur under reasonably foreseeable operating conditions.

Maximum voltages and concentrations of maximum voltage values shall be maintained within safe limits.

For the calculation of the pressure containment the appropriate values of the material properties, based on demonstrated data, shall be used, taking into account the provisions set out in paragraph 4 and the factors of adequate security.

The characteristics of the materials to be taken into consideration shall include, where appropriate:

The elastic limit, 0.2% or 1.0% conventional elasticity limit, as the case may be, at the calculation temperature.

The tensile strength.

The resistance based on time, that is, the resistance to the fluence.

Fatigue data.

The Young module (elasticity module).

The adequate amount of plastic deformation.

The power of breakage by bending.

The resistance to breakage.

They shall apply to the characteristics of the materials coefficients of resistance of the appropriate joints in function, for example, of the character of the non-destructive tests, of the properties of the joints of materials and of the planned operating conditions.

The design shall take due account of all reasonably foreseeable degradation processes (e.g., corrosion, fluency and fatigue) corresponding to the intended use of the equipment; the instructions to which the equipment is intended; refers to section 3.4 to draw attention to the characteristics of the design that are decisive for the life of the team, such as:

For fluence: the theoretical number of operating hours at specified temperatures.

For fatigue: the theoretical number of cycles at determined voltage levels.

For corrosion: the tolerance of theoretical corrosion.

c) Stability.

If the calculated thickness does not allow sufficient structural stability, the necessary measures shall be taken to correct it, taking into account the risks of transport and handling.

2.2.4 Experimental method of design.

The design of the equipment may be validated in whole or in part by a program of tests that will be carried out with a representative sample of the equipment or category of equipment.

The test programme shall be clearly defined before the tests are carried out and the notified body, if any, responsible for the design conformity assessment module, shall be accepted.

The program will define test conditions and acceptance or denial criteria. The exact values of the essential measures and the characteristics of the constituent materials of the test equipment shall be determined before the test.

Where appropriate, during the tests, the critical areas of the pressure equipment must be able to be observed with appropriate instruments that can measure the deformations and stresses with sufficient precision.

The trial program will include:

(a) A pressure resistance test to verify whether, at a pressure ensuring a defined safety margin with respect to the maximum permissible pressure, the equipment does not present significant leakage or deformation of more than one the test pressure shall be determined taking into account the differences between the values of the geometrical characteristics and the measured materials in the test conditions and the values allowed for the design; take into account the difference between the test and design temperatures.

(b) Where there is a risk of fluency or fatigue, appropriate tests, determined on the basis of the service conditions provided for the equipment, for example the duration of service at specified temperatures or the number of cycles at certain voltage levels.

(c) Where necessary, complementary tests on other specific external factors referred to in paragraph 2.2.1, such as corrosion or external actions.

2.3 Provisions to ensure safe use and operation.

The operating mode of the pressure equipment shall be designed to ensure that its handling does not entail any reasonably foreseeable risk. Special attention shall be paid, where appropriate:

To openings and closures.

Dangerous discharges from safety valves.

To devices that prevent physical access while there is pressure or vacuum.

At surface temperature, taking into account the intended use.

To the breakdown of unstable fluids.

In particular, pressure equipment fitted with a visiting door shall be fitted with an automatic or manual device that allows the user to easily ensure that the opening poses no risk. In addition, when such opening can be operated quickly, the pressure equipment shall be equipped with a device that prevents the opening when the pressure or temperature of the fluid poses a risk.

2.4 Media:

(a) Pressure equipment shall be designed in such a way as to enable all necessary examinations for its safety to be carried out.

(b) Means shall be provided for determining the internal state of the pressure equipment where necessary to ensure the permanent security of the equipment, such as openings that allow physical access to the interior of the equipment for be able to perform the appropriate tests safely and ergonomically.

c) Other means may be used to ensure that the pressure equipment meets all the safety requirements in any of the following situations:

When the computer is too small to physically access its interior.

When the opening of the pressure equipment can negatively affect the interior.

When it has been proven that the substance containing the pressure equipment does not impair the material with which it is manufactured, and that no other internal degradation mechanism is reasonably foreseeable.

2.5 Purge and vent systems.

Appropriate pressure equipment purge and ventilation systems shall be available when necessary for:

Avoid pernicious effects, such as battering ram, vacuum-caused collapse, corrosion and uncontrolled chemical reactions; all phases of operation and testing will be taken into account, in The pressure tests shall be carried out.

Allow cleaning, inspection, and maintenance safely.

2.6 Corrosion and other chemical actions.

Appropriate tolerance or protection against corrosion or other chemical actions shall be available, where necessary, taking due account of the intended and reasonably foreseeable use.

2.7 Unspend.

In case serious erosion or abrasion conditions can occur, appropriate measures will be taken to:

Reduce these effects to a minimum by appropriate design, such as by increasing the thickness of the material, or by using wrapped or coating materials.

Allow replacement of the most affected parts

Call attention, in the instructions referred to in section 3.4, on the measures necessary for a use under permanent security conditions.

2.8 Sets.

Sets will be designed so that:

The items to be joined are suitable and reliable for your service.

All elements are properly integrated and properly joined.

2.9 Fill and flush provisions.

Where appropriate, the pressure equipment shall be designed and fitted with suitable fittings, or its installation shall be provided, to ensure that filling and emptying are carried out in safety conditions as far as it is concerned. The following risks:

a) In the filling:

Excessive filling or overpressure in relation, in particular, with the degree of filling and the vapour pressure at the reference temperature.

The instability of the pressure equipment.

b) In the emptying: the uncontrolled discharge of pressurized fluid.

c) Both in filling and emptying: connections and disconnections that pose risks.

2.10 Protection against overshooting of the permissible limits of pressure equipment.

When, under reasonably foreseeable conditions, permissible limits may be exceeded, the pressure equipment shall be equipped with suitable protective devices, or designed to install them, unless the protection is guaranteed by other protection devices integrated into the assembly.

The appropriate device or combination of appropriate devices will be determined based on the particular characteristics of the equipment or the assembly.

Protection devices and combinations of these devices will include:

(a) The security accessories as defined in Article 2.4.

(b) Where appropriate, appropriate control mechanisms such as indicators or alarms, allowing for appropriate, manual or automatic intervention to keep the equipment under pressure within the permissible limits.

2.11 Security Accessories.

2.11.1 Security accessories must:

Design and manufacture in such a way as to be reliable and adapted to the intended service conditions and to take into account, where appropriate, the requirements for the maintenance and testing of devices.

Be independent of the other functions, unless they cannot affect their security function.

Respond to appropriate design principles for convenient and reliable protection; these principles will include security in case of failure, redundancy, diversity and self-control.

2.11.2 Pressure-limiting devices.

These devices shall be so designed as to ensure that the pressure does not permanently exceed the maximum permissible pressure PS; however, a short increase in the pressure shall be permitted, where appropriate, according to the provisions of paragraph 7.3.

2.11.3 Temperature Control Devices.

These devices will have a proper response time for security reasons and compatible with the measurement function.

2.12 External fire.

Where necessary, pressure equipment shall be designed and, where appropriate, equipped with the appropriate fittings, or shall be prepared for incorporation in order to comply with the requirements relating to the equipment. damage limitation in the case of an external fire, taking into account, in particular, the use to which they are intended.

3. Manufacturing

3.1 Manufacturing procedures.

The manufacturer shall ensure the correct execution of the provisions laid down in the design stage by the application of appropriate techniques and methods, in particular as regards the aspects referred to in point (a). continuation.

3.1.1 Preparing the components.

The preparation of the components (e.g. die-cut and beveling) shall not cause defects, fissures or changes in the mechanical characteristics that may endanger the safety of the pressure equipment.

3.1.2 Permanent Unions.

The permanent joins of the materials and adjacent areas shall be exempt from surface or interior deficiencies that are detrimental to the safety of the equipment.

The properties of permanent joins must correspond to the specified minimum properties for the materials to be joined, unless other values are specifically taken into account in the design calculations. corresponding properties.

For pressure equipment, the permanent joints of the elements that contribute to the pressure resistance of the equipment and the elements that are directly integrated will be made by suitably qualified personnel and using appropriate procedures.

The procedures and personnel shall be approved, for pressure equipment of categories II, III and IV, by a competent third party, at the choice of the manufacturer:

A notified body.

A third entity recognised by a Member State as set out in Article 20.

To proceed with such approvals, the said third party shall perform or cause the examinations and tests provided for in the appropriate harmonised standards or equivalent tests and tests to be carried out.

3.1.3 Non-destructive tests.

For pressure equipment, non-destructive tests of permanent joints shall be performed by suitably qualified personnel. For pressure equipment of categories III and IV, such staff shall have been approved by a third entity recognised by a Member State pursuant to Article 20.

3.1.4 Thermal treatment.

When there is a risk that the manufacturing process will change the properties of the materials to the point of endangering the integrity of the pressure equipment, appropriate heat treatment will be applied in the corresponding stage of manufacture.

3.1.5 Traceability.

Appropriate procedures shall be established and maintained for the identification of the materials of the equipment elements that contribute to the pressure resistance by appropriate means, from the reception, through the production, until the final test of the pressure equipment manufactured.

3.2 Final Assessment.

The pressure equipment will be submitted to the final evaluation described below.

3.2.1 Final Inspection.

The pressure equipment shall be subjected to a final inspection to visually assess and by examination of the accompanying documents compliance with the requirements of this royal decree. The tests that have been carried out during the manufacture may be taken into account. To the extent necessary for safety reasons, the final inspection shall be carried out on the inside and outside of all parts of the equipment, where appropriate, in the course of the manufacturing process (for example, where it is no longer possible examine it during the final inspection).

3.2.2 Test.

The final assessment of the pressure equipment shall include a pressure resistance test which would normally consist of a hydrostatic pressure test at a pressure at least equal to, where applicable, the value established in the paragraph 7.4.

For category I equipment manufactured in series, this test may be carried out on a statistical basis.

In cases where the hydrostatic pressure test is harmful or not feasible, other recognised value tests may be carried out. Additional measures, such as non-destructive tests or other methods of equivalent efficacy, shall be applied before testing other than the hydrostatic pressure test.

3.2.3 Inspection of security devices.

For sets, the final assessment shall also include a check on the safety devices to verify whether the requirements laid down in paragraph 2.10 have been complied with.

3.3 Marks and Labelling.

In addition to the CE marking provided for in Articles 18 and 19 and the information to be provided in accordance with Article 6.6 and Article 8.3, the following information shall be provided:

a) For all pressure equipment:

The year of manufacture.

The identification of the pressure equipment according to its nature, such as the type, the identification of the series or the batch, and the serial number.

The maximum or minimum allowable limits.

(b) According to the type of pressure equipment, the additional information necessary for the safety of installation, operation or use, and, where appropriate, also for maintenance and periodic inspection, such as:

Volume V of the pressure equipment, expressed in litres (L).

The nominal pipe size (DN).

The applied test pressure (PT), expressed in bar, and the date.

The set pressure of the security device, expressed in bar.

The power of the pressure equipment, expressed in kW.

The power voltage, expressed in volts (V).

The intended use.

The degree of filling, expressed in kg/L.

The maximum filling mass, expressed in kg.

The mass of the tare, expressed in kg.

The group of fluids.

(c) Where appropriate, the warnings set out in the pressure equipment shall draw attention to inappropriate uses which, by experience, are known to occur.

The information referred to in paragraphs (a), (b) and (c) shall appear on the pressure equipment or on a characteristic plate solidly attached to it, except in the following cases:

Where appropriate, appropriate documentation may be used to prevent the repetition of marking on individual elements such as piping components intended for the same set.

When the pressure equipment is too small, for example, with the accessories, this information may appear on a label attached to the pressure equipment.

Labels or other appropriate means may be used to indicate the filling mass and warnings referred to in paragraph (c), provided that they remain legible during the appropriate period of time.

3.4 Operating Instructions:

(a) Where a pressure equipment is placed on the market, instructions intended for the user containing all the information necessary for safety in respect of the following shall be attached to the pressure equipment, to the extent that it is relevant:

The assembly, including the attachment of different pressure equipment.

The put into service.

Utilization.

Maintenance, including controls by the user.

(b) The instructions shall include the information indicated in the pressure equipment pursuant to paragraph 3.3, with the exception of the identification of the series, and shall be accompanied, where appropriate, by the technical and drawings documentation. and the necessary schemas for their correct understanding.

(c) Where appropriate, the instructions shall also refer to the risks of inappropriate use in accordance with paragraph 1.3 and the particular characteristics of the design in accordance with paragraph 2.2.3.

4. Materials

The materials used for the manufacture of the pressure equipment shall be suitable for this application during the intended lifetime, unless replacement is provided for.

Welding materials and other bonding materials shall only comply with the relevant requirements of paragraph 4.1, paragraph 4.2 (a), and the first subparagraph of paragraph 4.3, both individually and once. together.

4.1 Materials of the parts under pressure:

(a) They shall have characteristics appropriate to the set of reasonably foreseeable operating conditions and test conditions and, in particular, shall have sufficient ductility and hardness; where appropriate, the characteristics of These materials shall comply with the requirements of paragraph 7.5. In addition, a suitable selection of materials shall be carried out in particular to prevent, if necessary, a break by fragilisation; where, for specific reasons, the material is Use of fragile materials will take appropriate action.

(b) They shall have sufficient chemical resistance to the fluid contained in the pressure equipment; the chemical and physical properties necessary for safe operation shall not be significantly altered during the intended lifetime. of the equipment.

c) They will not be significantly sensitive to aging.

d) They will be appropriate for the intended processing methods.

e) They will be selected in such a way that significant negative effects are avoided when different materials are joined.

4.2 The manufacturer of the equipment under pressure:

(a) It shall adequately define the values necessary for the design calculations referred to in paragraph 2.2.3, as well as the essential characteristics of the materials and their treatment referred to in paragraph 4.1.

b) Include in the technical documentation the data corresponding to the compliance with the provisions of this royal decree concerning the materials, in one of the following ways:

The use of materials compliant with harmonised standards.

The use of materials that have received a European approval of materials for pressure equipment in accordance with Article 15.

A particular assessment of materials.

(c) For pressure equipment of categories III and IV, it shall ensure that the notified body responsible for the conformity assessment procedures of the pressure equipment carries out a specific assessment of the Particular assessment of materials.

4.3 The equipment manufacturer shall take appropriate measures to ensure that the material used complies with the required specifications. In particular, in respect of each material, documentation shall be obtained from its manufacturer certifying compliance with a particular specification.

For the main pressure parts of categories II, III and IV equipment, this documentation shall consist of a specific product control certificate.

When a manufacturer of materials has an appropriate quality assurance system, certified by a competent body established in the Union and has been subject to a specific assessment in relation to the materials, certificates issued by the manufacturer shall be presumed to demonstrate compliance with the relevant requirements of this paragraph.

B. Specific requirements for certain pressure equipment

In addition to the requirements set out in paragraphs 1 to 4, the following requirements shall apply to the pressure equipment set out in paragraphs 5 and 6.

5. Pressure equipment subjected to the action of the flame or to a heat input which represents a risk of overheating referred to in Article 4

This category of pressure equipment comprises:

The steam and hot water generators referred to in Article 4.1.2, such as hot water and steam boilers with household, superheaters and heating boilers, heat recovery boilers, Waste incineration boilers, electric heating boilers with electrodes or immersion type and pressure cookers, with their accessories and, where appropriate, their systems for the treatment of food and water supply fuel.

Equipment for heating processes other than hot water or steam generators, as referred to in Article 4.1.1, such as heaters for chemical processes and other similar processes and pressurized equipment for the food preparation.

These pressure equipment shall be calculated, designed and manufactured in such a way as to avoid or minimize the risk of significant loss of containment due to overheating. In particular, it shall be ensured that, as appropriate:

(a) Appropriate means of protection are established to limit operating parameters such as input and heat dissipation and, if appropriate, the level of the fluid to avoid any risk of local overheating or general.

(b) Sample sampling points shall be provided when necessary to assess the properties of the fluid in order to avoid any risk related to deposits or corrosion.

(c) The necessary arrangements are made to eliminate the risks of damage from deposits.

d) The means to safely dissipate residual heat after the strike is available.

e) Provisions shall be made to prevent the dangerous accumulation of flammable mixtures of combustible and air substances or the return of flame.

6. Pipes as defined in Article 4.1.3.

Design and manufacturing will ensure that:

(a) The risk of permanent deformation resulting from unacceptable free movements or excessive efforts, e.g. in flanges, connections, corrugated flexible tubes or extensible tubes, is adequately controlled by clamps, braces, fasteners, settings, and pretensioners.

(b) Where there is a possibility of condensation of gaseous fluids inside the tubes, the necessary means to purge and expel the deposits from the low zones are available in order to avoid damage due to the blow of ram or corrosion.

(c) Due account shall be taken of the potential damage resulting from the turbulence and the formation of whirlwinds; in this respect the relevant provisions of paragraph 2.7 shall apply.

d) The risk of fatigue due to vibrations in the tubes is duly taken into account.

e) Where the pipes contain group 1 fluids, adequate means are available to isolate the intake ducts which present significant risks due to their size.

f) The risk of accidental discharge is minimised; the shots will be visibly marked on the permanent side, specifying the fluid content.

g) The position and route of the underground pipes are recorded at least in the technical documentation to facilitate maintenance, inspection or repair under safety conditions.

7. Specific quantitative requirements for certain pressure equipment

The following provisions are applicable as a general rule. However, where they do not apply, even where the materials are not specifically mentioned or harmonised standards are applied, the manufacturer must justify the application of appropriate provisions to obtain a level of equivalent global security.

The provisions set out in this Section are complementary to the essential safety requirements of paragraphs 1 to 6 for the pressure equipment to which they apply.

7.1 Eligible Tensions.

7.1.1 Symbols. Re/t, elastic limit, designates value at calculation temperature:

The upper flow limit for materials that have lower and upper flow limits.

The conventional 1.0% elasticity limit for austenitic steel and non-alloy aluminum.

The conventional elasticity limit of 0.2% in other cases.

Rm/20 designates the minimum tensile strength value at 20 ° C.

Rm/t designates the maximum tensile strength at the calculation temperature.

7.1.2 The overall permissible membrane voltage for predominantly static loads and for temperatures outside the range in which the yield phenomena are significant, shall not be higher than the lower of the values the following, depending on the material concerned:

In the case of ferritic steel, including standard steel (normalized laminate) and excluding fine-grained steels and steels subjected to special heat treatment, 2/3 of R e/t and 5/12 of R m/20.

In the case of austenitic steel:

If your elongation after breakage is greater than 30%, 2/3 of R e/t.

O, alternatively, and if its elongation after breakage is greater than 35%, 5/6 of R e/t and 1/3 of R m/t.

In the case of moulded, non-alloy or low alloy steel, 10/19 of R e/t and 1/3 of R m/20.

In the case of aluminum, 2/3 of R e/t.

In the case of aluminium alloys, except for precipitation hardening, 2/3 of R e/t and 5/12 of R m/20.

7.2 Coefficient joints.

For welded joints, the coefficient of the joints shall not exceed the following values:

For equipment that is the object of destructive and non-destructive tests to verify that the assembly of the joints does not have significant deficiencies: 1.

For equipment that is the object of non-destructive random testing: 0.85.

For equipment that is not the subject of non-destructive tests other than visual inspection: 0,7.

When necessary, the type of tension and mechanical and technological properties of the gasket shall also be taken into account.

7.3 Pressure-limiting devices, especially intended for pressure vessels.

The momentary pressure increase referred to in paragraph 2.11.2 shall be maintained at 10% of the maximum permissible pressure.

7.4 Hydrostatic test pressure.

For pressure vessels, the hydrostatic test pressure referred to in paragraph 3.2.2 shall be at least equal to the highest of the following two values:

The pressure corresponding to the maximum load to which the equipment may be subjected, having regard to its maximum permissible pressure and its maximum permissible temperature, multiplied by the coefficient 1,25.

The maximum allowable pressure multiplied by the coefficient 1.43.

7.5 Characteristics of the materials.

Unless different values are required according to different criteria to be taken into consideration, the steel shall be considered to be sufficiently ductility, in accordance with paragraph 4.1.1, when its elongation thereafter the break in a traction test carried out in accordance with a standard procedure is at least equal to 14% and its bending energy measured in an ISO V test is at least equal to 27 J at a temperature not exceeding 20 ° C, but not higher than the lowest operating temperature predicted.

ANNEX II

Compliance Assessment Tables

1. The following references have been used in the tables to designate the module categories:

I = Module A.

II = Modules A2, D1, E1.

III = Modules B (design type) + D, B (design type) + F, B (production type) + E, B (production type) + C2, H.

IV = Modules B (production type) + D, B (production type) + F, G, H1.

2. The safety fittings defined in Article 2.4 and listed in Article 4.1.4 are classified in category IV. However, as an exception, safety fittings manufactured for specific equipment may be classified in the same category as the equipment they protect.

3. The pressure fittings defined in Article 2.5 and listed in Article 4.1.4 are classified according to the following:

Your maximum allowable pressure PS.

From your V volume or nominal DN size, as the case may be.

From the group of fluids to which they are intended.

The corresponding box for the containers or pipes shall be used to determine the category of conformity assessment.

When the nominal volume and size referred to in the second indent of the first paragraph are considered appropriate, the pressure fitting shall be classified in the highest category.

4. The demarcation lines drawn in the following conformity assessment tables point to the upper limit for each category.

Table 1. Vessels referred to in Article 4 (1) (a) (1) (1)

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By way of derogation, containers intended to contain an unstable gas and which should fall within categories I or II in application of Table 1 shall be classified in category III.

Table 2. Recincipient referred to in Article 4 (1.1), paragraph a.2.)

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As an exception, portable fire extinguishers and bottles for breathing apparatus shall be classified at least in category III.

Table 3. Vessels referred to in Article 4 (1) (b)

1)

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Table 4. Vessels referred to in Article 4 (1) (b) (b)

2)

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By way of derogation, the sets intended for the production of hot water referred to in the second paragraph of Article 4.2 shall be the subject of an EU-type examination (module B: type of design) in order to verify their compliance with the essential requirements laid down in paragraphs 2.10, 2.11 and 3.4 and paragraph 5 (a) and (d) of Annex I or a system of full quality assurance (module H).

Table 5. Pressure equipment referred to in Article 4 (2) (

)

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As an exception, pressure cookers shall be subject to a conformity assessment procedure equivalent to at least one of the modules in category III.

Table 6. Pipes referred to in Article 4 (1.3), paragraph a.1.)

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By way of derogation, pipes intended for unstable gases and belonging to categories I or II in application of Table 6 shall be classified in category III.

Table 7. Pipes referred to in Article 4 (1.3), paragraph a.2.)

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By way of derogation, all pipes containing fluids at a temperature of more than 350 ° C and belonging to category II in application of Table 7 shall be classified in category III.

Table 8. Pipes referred to in Article 4 (1.3), paragraph b.1)

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Table 9. Pipes referred to in Article 4 (1.3), paragraph b.2)

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ANNEX III

Compliance assessment procedures

The obligations arising from the provisions set out in this Annex for pressure equipment shall also apply to assemblies.

Module A

(Internal production control)

1. Concept.

The internal control of production is the conformity assessment procedure whereby the manufacturer fulfils the obligations set out in paragraphs 2, 3 and 4, and ensures and declares, under its exclusive responsibility, which the pressure equipment in question satisfies the requirements of this royal decree.

2. Technical documentation.

The manufacturer will produce the technical documentation.

The technical documentation shall allow the assessment of the compliance of the pressure equipment with the relevant requirements and shall include an appropriate risk assessment and assessment. It shall specify the applicable requirements and provide for the design, manufacture and operation of the pressure equipment to the extent that it is relevant for the assessment, design, manufacture and operation of the equipment. The technical documentation shall include, where appropriate, at least the following elements:

A general description of the pressure equipment.

The design and manufacturing plans and the schemas of the components, subsets, circuits, etc.

The descriptions and explanations required for the understanding of such plans and schemes and the operation of the equipment under pressure.

A list of harmonised standards, applied in whole or in part, the references of which have been published in the Official Journal of the European Union, and, where those harmonised standards have not been applied, the description of the solutions adopted to meet the essential safety requirements of this Royal Decree; in the case of harmonised standards which are applied in part, the parts that have been applied shall be specified in the technical documentation.

The results of the design calculations performed, the examinations performed, etc.

The reports on the trials.

3. Manufacturing.

The manufacturer shall take all necessary measures to ensure that the manufacturing process and its monitoring ensure the conformity of the pressure equipment manufactured with the technical documentation provided for in paragraph 2 and with the requirements of this royal decree.

4. CE marking and EU declaration of conformity.

4.1 The manufacturer shall affix the CE marking to each pressure equipment that satisfies the applicable requirements of this royal decree.

4.2 The manufacturer shall draw up an EU declaration of conformity for the pressure equipment model and keep it together with the technical documentation at the disposal of the national authorities for a period of 10 years from the date of the introduction of pressure equipment into the market. The EU declaration of conformity shall identify the pressure equipment for which it has been drawn up.

A copy of the EU declaration shall be provided in accordance with the competent authorities upon request.

5. Authorized representative.

The manufacturer's obligations referred to in paragraph 4 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in his mandate.

Module A2

(Internal control of the most monitored production of the equipment

at random intervals pressure)

1. Concept.

Internal production control plus supervised control of pressure equipment at random intervals constitutes the conformity assessment procedure whereby the manufacturer fulfils the obligations set out in paragraphs 2, 3, 4 and 5, and ensures and declares, under its sole responsibility, that the pressure equipment in question meets the requirements of this royal decree.

2. Technical documentation.

The manufacturer will produce the technical documentation. The documentation shall allow the assessment of whether the pressure equipment meets the relevant requirements and shall include an appropriate risk assessment and assessment. It shall specify the applicable requirements and provide for the design, manufacture and operation of the pressure equipment to the extent that it is relevant for the assessment, design, manufacture and operation of the equipment. The technical documentation shall include, where appropriate, at least the following elements:

A general description of the pressure equipment.

The design and manufacturing plans and the schemas of the components, subsets, circuits, etc.

The descriptions and explanations required for the understanding of such plans and schemes and the operation of the equipment under pressure.

A list of harmonised standards, applied in whole or in part, the references of which have been published in the Official Journal of the European Union and, where these harmonised standards have not been applied, the description of the solutions adopted to meet the essential safety requirements of this Royal Decree; in the case of harmonised standards which are applied in part, the parts that have been applied shall be specified in the technical documentation.

The results of the design calculations performed, the examinations performed, etc.

The reports on the trials.

3. Manufacturing.

The manufacturer shall take all necessary measures to ensure that the manufacturing process and its monitoring ensure the conformity of the pressure equipment manufactured with the technical documentation referred to in paragraph 2 and with the requirements of this royal decree that apply to you.

4. Final evaluation and controls of the pressure equipment.

The manufacturer shall carry out a final assessment of the pressure equipment, subject to monitoring by unannounced visits from a notified body chosen by the manufacturer.

The notified body shall carry out or mandate checks on products at random intervals which it shall determine to verify the quality of the internal controls of the pressure equipment, taking into account, other things, the technological complexity of the pressure equipment and the volume of production.

During these unannounced visits, the notified body:

Ensure that the manufacturer effectively performs the final assessment in accordance with paragraph 3.2 of Annex I.

Take samples of the equipment under pressure at the manufacturing or storage premises to carry out the checks; the notified body shall determine the number of samples of equipment to be taken, as well as the need for carry out or send the final evaluation of the samples in full or in part.

The acceptance sampling procedure to be applied is intended to determine whether the manufacturing process of the pressure equipment is carried out within acceptable limits with a view to ensuring compliance of the equipment.

In the event that one or more pressure equipment or assemblies are not compliant, the notified body shall take appropriate action.

The manufacturer, under the responsibility of the notified body, shall affix the notified body's identification number during the manufacturing process.

5. CE marking and EU declaration of conformity.

5.1 The manufacturer shall affix the CE marking to each pressure equipment that satisfies the applicable requirements of this royal decree.

5.2 The manufacturer shall draw up an EU declaration of conformity for the pressure equipment model and keep it together with the technical documentation at the disposal of the national authorities for a period of 10 years after the the introduction of pressure equipment into the market. The EU declaration of conformity shall identify the pressure equipment for which it has been drawn up.

A copy of the EU declaration shall be provided in accordance with the competent authorities upon request.

6. Authorized representative.

The manufacturer's obligations referred to in paragraph 5 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in his mandate.

Module B

("EU type" examination)

I. EU production type examination

1. The EU-type examination-type of production-is the part of a conformity assessment procedure whereby a notified body examines the technical design of a pressure equipment and verifies and attests that its technical design complies with the requirements of the requirements of this royal decree.

2. The EU-type examination-type of production-should be carried out in the form of an assessment of the adequacy of the technical design of the equipment under pressure by examining the technical documentation and supporting documentation referred to in the paragraph 3, and in the form of an examination of a sample, representative of the intended production, of the complete pressure equipment.

3. The manufacturer shall submit an EU type examination application to a single notified body of his choice. Such application shall include:

The name and address of the manufacturer and, if the request is submitted by the authorized representative, the name and address of the manufacturer.

A written declaration specifying that the same application has not been filed with another notified body.

The technical documentation; the technical documentation shall permit the assessment of the conformity of the equipment under pressure with the applicable requirements of this Royal Decree and shall include an appropriate analysis and assessment of the risks; specify the applicable requirements and shall provide as appropriate for the assessment, design, manufacture and operation of the equipment under pressure; the technical documentation shall, where appropriate, contain at least the following: items:

A general description of the pressure equipment.

The design and manufacturing plans and schemas of the components, subsets, circuits, etc.

The descriptions and explanations required for the understanding of such plans and schemes and the operation of the equipment under pressure.

A list of harmonised standards, applied in whole or in part, the references of which have been published in the Official Journal of the European Union and, where these harmonised standards have not been applied, the description of the solutions adopted to meet the essential safety requirements of this royal decree; in the case of harmonised standards which are applied in part, the parts that have been applied shall be specified in the technical documentation.

The results of the design calculations performed, the examinations performed, etc.

The reports on the trials.

The data for the planned tests during manufacture.

The data for the necessary approvals or qualifications in accordance with paragraphs 3.1.2 and 3.1.3 of Annex I.

The representative samples of the intended production, the sample may include several versions of the equipment under pressure, provided that the differences between them do not affect the level of safety. The notified body may request further samples if the test programme so requires.

The supporting documentation for the adequacy of the technical design; this supporting documentation will mention all the documents that have been used, in particular, if the relevant harmonised standards have not been applied in full; the supporting documentation shall include, if necessary, the results of the tests carried out in accordance with other relevant technical specifications by the appropriate laboratory of the manufacturer or by another test laboratory in his/her name and under his/her responsibility.

4. The notified body.

4.1 You will examine the technical documentation and supporting documentation to assess the adequacy of the technical design of the pressure equipment and the manufacturing procedures.

In particular, the notified body:

Evaluate materials when they are not in conformity with the relevant harmonised standards or with a European approval of materials for pressure equipment and shall check the certificate issued by the manufacturer of the material, with in accordance with the provisions of paragraph 4.3 of Annex I.

approve the permanent joining methods of the parts of the equipment under pressure, or verify whether they have been approved in advance, in accordance with paragraph 3.1.2 of Annex I.

Verify whether the personnel in charge of permanent union of the parts of the equipment under pressure and the performance of the non-destructive tests are qualified or approved in accordance with paragraphs 3.1.2 or 3.1.3 of Annex I.

4.2 Verify that the samples have been manufactured in accordance with the technical documentation, and identify the elements that have been designed in accordance with the applicable provisions of the relevant harmonised standards, as well as the elements that have been designed using other relevant technical specifications, without applying the relevant provisions of those standards.

4.3 It shall carry out appropriate examinations and tests to check whether, when the manufacturer has chosen to apply the solutions of the relevant harmonised standards, these solutions have been correctly applied.

4.4 It shall carry out the necessary tests and tests to check whether, in the event that the solutions of the relevant harmonised standards have not been applied, the solutions adopted by the manufacturer applying other Relevant technical specifications meet the relevant safety requirements of this royal decree.

4.5 Acordara with the manufacturer shall be the place where the examinations and tests shall be carried out.

5. The notified body shall draw up an assessment report containing the activities carried out in accordance with paragraph 4 and its results. Without prejudice to its obligations to the notifying authority, the notified body shall only disclose the content of this report, in full or in part, with the agreement of the manufacturer.

6. If the type meets the requirements of this royal decree, the notified body shall issue to the manufacturer an EU-type examination certificate-type of production. Without prejudice to paragraph 7, this certificate shall be valid for 10 years and shall be renewable and shall include the name and address of the manufacturer, the conclusions of the examination, the conditions of validity (where applicable) and the data required to identify the approved type.

A list of the relevant parts of the technical documentation shall be attached to the certificate and a copy shall be kept by the notified body.

The certificate and its annexes shall contain all relevant information to assess the conformity of the equipment at pressure manufactured with the type examined and to allow the control in service.

If the type does not satisfy the applicable requirements of this royal decree, the notified body shall refuse to issue an EU-type examination certificate-type of production-and inform the applicant accordingly, explaining in detail its refusal. A resource procedure must exist.

7. The notified body shall be kept informed of any developments in the current state of the art indicating that the approved type can no longer meet the applicable requirements of this royal decree, and shall determine whether such changes require further investigations. In that case, the notified body shall inform the manufacturer accordingly.

The manufacturer shall inform the notified body which maintains the technical documentation related to the EU-type examination certificate concerning the type of production concerning any modification of the approved type which may be affect the conformity of the equipment under pressure with the essential safety requirements of this royal decree or the conditions of validity of the said certificate. Such amendments shall require additional approval in the form of addition to the original EU-type examination certificate concerning the type of production.

8. Each notified body shall inform its notifying authority of EU-type examination certificates of type-type of production-and/or any additions thereto which it has issued or withdrawn, and shall, on a regular basis or on request, put the the list of such certificates and/or additions thereto which it has rejected, suspended or otherwise restricted, is available to its notifying authority.

Each notified body shall inform the other notified bodies of the EU type-of-production-type examination certificates and/or any additions thereto which it has rejected, withdrawn, suspended or otherwise restricted. and, upon request, on those certificates and/or additions thereto which it has issued.

The Commission, the Member States and the other notified bodies may, on request, obtain a copy of the EU-type examination certificates-type of production-or their additions. On request, the Commission and the Member States may obtain a copy of the technical documentation and the results of the examinations carried out by the notified body. The notified body shall be in possession of a copy of the EU-type examination certificate-type of production-its annexes and additions, as well as of the technical file containing the documentation submitted by the manufacturer, until the end of the validity of that certificate.

9. The manufacturer shall keep at the disposal of the national authorities a copy of the EU-type examination certificate-type of production-its annexes and additions, as well as the technical documentation for a period of 10 years from the date of the introduction of the equipment under pressure in the market.

10. The authorised representative of the manufacturer may submit the application referred to in paragraph 3 and fulfil the obligations referred to in paragraphs 7 and 9, provided that they are specified in his mandate.

II. EU-type examination concerning the type of design

1. The EU-type examination of the type of design is the part of a conformity assessment procedure whereby a notified body examines the technical design of the equipment under pressure and verifies and attests that its technical design meets the requirements of the requirements of this royal decree.

2. The EU-type examination of the type of design shall consist of an assessment of the adequacy of the technical design of the equipment under pressure, by examination of the technical documentation and supporting documentation referred to in paragraph 3, without examining a sample.

The experimental design method referred to in paragraph 2.2.4 of Annex I may not be used in this module.

3. The manufacturer shall submit an EU-type examination application for the type of design to a single notified body of his choice.

This request will include:

The name and address of the manufacturer and, if the request is submitted by the authorized representative, the name and address of the manufacturer.

A written declaration specifying that the same application has not been filed with another notified body.

The technical documentation.

The technical documentation shall permit the assessment of the conformity of the equipment under pressure with the applicable requirements of this Royal Decree and shall include an appropriate risk assessment and analysis; specify the applicable requirements and shall, as far as relevant for the assessment, design, manufacture and operation of the equipment under pressure, be provided for.

The technical documentation shall contain, where appropriate, at least the following elements:

A general description of the pressure equipment.

The design and manufacturing plans and the schemas of the components, subsets, circuits, etc.

The descriptions and explanations required for the understanding of such plans and schemes and the operation of the equipment under pressure.

A list of harmonised standards, applied in whole or in part, the references of which have been published in the Official Journal of the European Union and, where these harmonised standards have not been applied, the description of the solutions adopted to meet the essential safety requirements of this royal decree; in the case of harmonised standards which are applied in part, the parts that have been applied, the results of the tests, will be specified in the technical documentation. design calculations performed, examinations performed, etc.

The data for the necessary qualifications or approvals in accordance with paragraphs 3.1.2 and 3.1.3 of Annex I.

The supporting documentation for the adequacy of the technical design; this supporting documentation will mention all the documents that have been used, in particular, if the relevant harmonised standards have not been applied in full; the supporting documentation shall include, if necessary, the results of the tests carried out by the appropriate laboratory of the manufacturer, or by another test laboratory on its behalf and under its responsibility.

The request may refer to various versions of the equipment under pressure, provided the differences between those versions do not affect the security level.

4. The notified body shall be responsible for the following.

4.1 Examine the technical documentation and supporting documentation to assess the adequacy of the technical design of the product.

In particular, the notified body shall:

Evaluate the materials used, if these are not in conformity with the applicable harmonised standards or with a European approval of materials for pressure equipment, approve the methods of permanent union of the parties of the pressure equipment or to verify whether they have been approved in advance, in accordance with paragraph 3.1.2 of Annex I.

4.2 Carry out the appropriate tests to check whether, when the manufacturer has chosen to apply the solutions of the relevant harmonised standards, these solutions have been correctly applied.

4.3 To carry out the appropriate tests to check whether, in the event that the solutions of the relevant harmonised standards have not been applied, the solutions adopted by the manufacturer meet the essential safety requirements corresponding to this royal decree.

5. The notified body shall draw up an assessment report containing the activities carried out in accordance with paragraph 4 and its results. Without prejudice to its obligations to the notifying authorities, the notified body shall only disclose the content of this report, in full or in part, with the agreement of the manufacturer.

6. If the design meets the requirements of this royal decree, the notified body shall issue to the manufacturer an EU-type examination certificate relating to the type of design. Without prejudice to paragraph 7, the certificate shall be valid for 10 years and shall be renewable and shall include the name and address of the manufacturer, the conclusions of the examination, the conditions of validity (where applicable) and the data required to identify the approved design.

A list of the relevant parts of the technical documentation shall be attached to the certificate and a copy shall be kept by the notified body.

The certificate and its annexes shall contain all relevant information to assess the conformity of the pressure equipment manufactured with the examined design and to allow the control in service.

If the design does not satisfy the applicable requirements of this royal decree, the notified body shall refuse to issue an EU-type examination certificate concerning the design type and inform the applicant accordingly, explaining in detail their refusal.

7. The notified body shall be kept informed of changes in the generally recognised state of the art which indicate that the approved design can no longer meet the applicable requirements of this royal decree, and shall determine whether such changes require further investigation. In that case, the notified body shall inform the manufacturer accordingly.

The manufacturer shall inform the notified body which has in its possession the technical documentation relating to the EU-type examination certificate concerning the design type for any modifications to the approved design which may affect the the conformity of the equipment under pressure with the essential safety requirements of this royal decree or the conditions of validity of the said certificate. Such amendments shall require additional approval in the form of an addition to the original EU-type examination certificate relating to the type of design.

8. Each notified body shall inform its notifying authority of the EU type-examination certificates relating to the type of design and/or any additions thereto it has issued or withdrawn, and shall, on a regular basis or on request, put the the list of certificates and/or additions thereto which it has rejected, suspended or otherwise restricted, is available to its notifying authority.

Each notified body shall inform the other notified bodies of the EU-type examination certificates relating to the type of design and/or any additions thereto which it has rejected, withdrawn, suspended or restricted from another mode and, upon request, on those certificates and/or any additions thereto it has issued.

The Commission, the Member States and the other notified bodies may, on request, obtain a copy of the EU-type examination certificates relating to the type of design or their additions. On request, the Commission and the Member States may obtain a copy of the technical documentation and the results of the examinations carried out by the notified body. The notified body shall be in possession of a copy of the EU-type examination certificate relating to the type of design, its annexes and additions, as well as the technical file containing the documentation submitted by the manufacturer until the end of the year. of the validity of that certificate.

9. The manufacturer shall keep at the disposal of the national authorities a copy of the EU-type examination certificate relating to the type of design, its annexes and additions, as well as the technical documentation, for a period of 10 years from the date of introduction of the equipment under pressure in the market.

10. The authorised representative of the manufacturer may submit the application referred to in paragraph 3 and fulfil the obligations referred to in paragraphs 7 and 9, provided that they are specified in his mandate.

C2 Module

(Compliance with type based on internal control of production plus monitored control of pressure equipment at random intervals)

1. Concept.

Conformity to the type based on internal control of production plus supervised control of pressure equipment at random intervals is the part of a conformity assessment procedure whereby the the manufacturer complies with the obligations set out in paragraphs 2, 3 and 4, and ensures and declares, under his sole responsibility, that the pressure equipment concerned is in conformity with the type described in the EU-type examination certificate; and satisfy the requirements of this royal decree that apply to them.

2. Manufacturing.

The manufacturer shall take all necessary measures to ensure that the manufacturing process and its monitoring ensure the conformity of the pressure equipment manufactured with the type described in the EU-type examination certificate and with the requirements of this royal decree that apply to them.

3. Final evaluation and controls of the pressure equipment.

A notified body chosen by the manufacturer shall carry out, or perform, checks on the product at random intervals determined by the body in order to verify the quality of the final assessment and the checks internal pressure equipment, taking into account, inter alia, the technological complexity of such equipment and the quantity produced.

The notified body shall ensure that the final assessment is effectively carried out by the manufacturer in accordance with paragraph 3.2 of Annex I.

An appropriate sample of the finished pressure equipment, taken on site by the notified body prior to its placing on the market, shall be examined and appropriate tests, as indicated by the relevant parties, shall be carried out. harmonised standards, and/or equivalent tests set out in other technical specifications, to check the conformity of the equipment under pressure with the relevant requirements of this Royal Decree.

The notified body shall determine the number of samples of equipment to be taken, as well as the need to perform or to carry out full or partial completion of the final assessment in the pressure equipment constituting the shows.

In cases where a sample does not reach an acceptable level of quality, the notified body shall take appropriate measures.

The acceptance sampling procedure to be applied is intended to determine whether the manufacturing process of the pressure equipment is carried out within acceptable limits with a view to ensuring compliance of the equipment.

If the tests are carried out by a notified body, the manufacturer, under the responsibility of the notified body, shall affix the identification number of the notified body during the process of manufacturing.

4. CE marking and EU declaration of conformity.

4.1 The manufacturer shall affix the CE marking to each pressure or assembly equipment that is in conformity with the type described in the EU-type examination certificate and satisfies the applicable requirements of this royal decree.

4.2 The manufacturer shall draw up an EU declaration of conformity for each pressure equipment model and keep it at the disposal of the national authorities for a period of 10 years from the introduction of the equipment to pressure on the market. The EU declaration of conformity shall identify the model of pressure equipment for which it has been drawn up.

A copy of the EU declaration shall be provided in accordance with the competent authorities upon request.

5. Authorized representative.

The manufacturer's obligations referred to in paragraph 4 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in his mandate.

Module D

(Compliance with type based on quality assurance of the production process)

1. Concept.

The conformity with the type based on quality assurance of the production process is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in the paragraphs 2 and 5, and ensures and declares, under its sole responsibility, that the pressure or joint equipment in question is in conformity with the type described in the EU-type examination certificate and satisfies the requirements of this royal decree which is apply to you.

2. Manufacturing.

The manufacturer shall manage an approved quality system for production as well as for the inspection of the finished product and the tests of the pressure equipment concerned as specified in paragraph 3 and shall be subject to the surveillance referred to in paragraph 4.

3. Quality system.

3.1 The manufacturer shall submit an application for the assessment of his quality system to the notified body of his choice, for the pressure equipment concerned.

This request will include:

The name and address of the manufacturer and, if the application is submitted by the authorized representative, also the name and address of the authorized representative.

A written declaration specifying that the same application has not been filed with another notified body.

All relevant information about the type of pressure equipment in question.

The documentation for the quality system.

The technical documentation of the approved type and a copy of the EU type examination certificate.

3.2 The quality system shall ensure that the pressure equipment is in conformity with the type described in the EU type-examination certificate and satisfies the requirements of this royal decree that apply to them.

All elements, requirements and provisions adopted by the manufacturer shall be contained in a systematic and orderly documentation in the form of measures, procedures and instructions, all in writing.

This quality system documentation will allow for a uniform interpretation of quality programs, plans, manuals, and files.

In particular, it will include an appropriate description of:

Quality objectives, organization chart and responsibilities and powers of management personnel as regards the quality of pressure equipment.

The corresponding techniques, processes and systematic actions of manufacture, quality control and quality assurance to be used, and in particular the procedures for the permanent union of the approved parts in accordance with paragraph 3.1.2 of Annex I.

Tests and tests that will be performed before, during, and after manufacturing and their frequency.

Quality dossiers, such as inspection reports, test and calibration data, reports on the qualification or approval of the staff concerned, and in particular the staff in charge of the union permanent parts and non-destructive testing in accordance with paragraphs 3.1.2 and 3.1.3 of Annex I, etc.

The means by which the achievement of the required quality and the effective functioning of the quality system are monitored.

3.3 The notified body shall evaluate the quality system to determine whether it meets the requirements referred to in paragraph 3.2

You will be given the compliance with those requirements of the quality system elements that meet the corresponding specifications of the corresponding harmonised standard.

In addition to experience in quality management systems, the team of auditors will have at least one member who has experience in the field of pressure equipment assessment and pressure equipment technology. in question, as well as knowledge of the applicable requirements of this royal decree. The audit shall include an inspection visit to the manufacturer's premises.

The audit team shall review the technical documentation referred to in the fifth indent of paragraph 3.1 to check whether the manufacturer is able to identify the relevant requirements of this royal decree and to carry out the examinations. necessary to ensure that the product complies with those requirements.

The decision will be notified to the manufacturer. The notification shall include the findings of the audit and the reasoned assessment decision.

3.4 The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it in a manner that continues to be appropriate and effective.

3.5 The manufacturer shall keep the notified body that has approved the quality system informed of any planned adaptation of that system.

The notified body shall assess the proposed adaptations and decide whether the modified quality system meets the requirements set out in paragraph 3.2 or whether a new assessment is necessary.

You will notify the manufacturer of your decision. The notification shall include the findings of the examination and the reasoned assessment decision.

4. Surveillance under the responsibility of the notified body.

4.1 The purpose of the surveillance is to verify that the manufacturer duly fulfils the obligations imposed on him by the approved quality system.

4.2 The manufacturer shall allow the notified body to enter the premises of manufacture, inspection, testing and storage for evaluation purposes and shall provide it with all the necessary information, in particular:

The documentation for the quality system.

Quality dossiers, such as inspection reports, test and calibration data, reports on the qualification of affected staff, etc.

4.3 The notified body shall carry out periodic audits to ensure that the manufacturer maintains and applies the quality system and shall provide the manufacturer with an audit report. The frequency of periodic audits shall be established in such a way that a full reassessment is carried out every three years.

4.4 Furthermore, the notified body may make unexpected visits to the manufacturer. The need and frequency of these additional visits will be determined by a monitoring system of visits to be carried out by the notified body. The following factors shall be taken into account in the visit control system, in particular:

The category of the pressure equipment.

The results of previous surveillance visits.

The need to check compliance with corrective measures.

When applicable, special conditions related to system approval.

Significant modifications of the organization, policy, or manufacturing techniques.

In the course of such visits, the notified body may, if deemed necessary, carry out tests on the product in order to verify the proper functioning of the quality system. That body shall submit to the manufacturer a report of the visit and, if any test has been carried out, a report of the visit.

5. CE marking and EU declaration of conformity.

5.1 The manufacturer shall affix the CE marking and, under the responsibility of the notified body referred to in paragraph 3.1, the latter's identification number on each pressure equipment conforming to the type described in paragraph 3.1. the EU type-examination certificate and satisfy the applicable requirements of this royal decree.

5.2 The manufacturer shall draw up an EU declaration of conformity for each pressure equipment model and keep it at the disposal of the national authorities for a period of 10 years from the introduction of the equipment to pressure on the market. The EU declaration of conformity shall identify the model of pressure equipment for which it has been drawn up.

A copy of the EU declaration shall be provided in accordance with the competent authorities upon request.

6. Preservation of documentation.

For a period of ten years from the introduction of the pressure equipment into the market, the manufacturer shall have at the disposal of the national authorities:

The documentation referred to in section 3.1.

The adaptation referred to in paragraph 3.5 that has been approved.

The decisions and reports of the notified body referred to in paragraphs 3.3, 3.5, 4.3 and 4.4.

7. Reporting duties of the notified body.

Each notified body shall inform its notifying authority of the approvals of quality systems issued or withdrawn and shall, on a regular basis or upon request, make available to its notifying authority the list of quality system approvals that you have rejected, suspended, or otherwise restricted.

Each notified body shall inform the other notified bodies of quality system approvals which it has rejected, suspended, withdrawn or otherwise restricted and, upon request, of the approvals of the quality systems that you have issued.

8. Authorized representative.

The manufacturer's obligations referred to in paragraphs 3.1, 3.5, 5 and 6 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in his mandate.

Module D1

(Ensuring the quality of the production process)

1. Concept.

The quality assurance of the production process is the conformity assessment procedure whereby the manufacturer fulfils the obligations set out in paragraphs 2, 4 and 7, and ensures and declares, under his sole responsibility, that the pressure equipment in question satisfies the requirements of this royal decree that apply to him.

2. Technical documentation.

The manufacturer will produce the technical documentation. The documentation shall allow the assessment of whether the pressure equipment meets the relevant requirements and shall include an appropriate risk assessment and assessment. It shall specify the applicable requirements and shall, in so far as it is relevant for the assessment, design, manufacture and operation of the product. The technical documentation shall include, where appropriate, at least the following elements:

A general description of the pressure equipment.

The design and manufacturing plans and the schemas of the components, subsets, circuits, etc.

The descriptions and explanations required for the understanding of such plans and schemes and the operation of the equipment under pressure.

A list of harmonised standards, applied in whole or in part, the references of which have been published in the Official Journal of the European Union and, where these harmonised standards have not been applied, the description of the solutions adopted to meet the essential safety requirements of this Royal Decree; in the case of harmonised standards which are applied in part, the parts that have been applied shall be specified in the technical documentation.

The results of the design calculations performed, the examinations performed, etc.

The reports on the trials.

3. Technical documentation.

The manufacturer shall keep the technical documentation at the disposal of the relevant national authorities for a period of 10 years from the introduction of the pressure equipment into the market.

4. Manufacturing.

The manufacturer shall manage an approved quality system for production as well as for the inspection of the finished product and the tests of the pressure equipment concerned as specified in paragraph 5 and shall be subject to the surveillance referred to in paragraph 6.

5. Quality system.

5.1 The manufacturer shall submit an application for the assessment of his quality system to the notified body of his choice, for the pressure equipment concerned.

This request will include:

The name and address of the manufacturer and, if the request is submitted by the authorized representative, the name and address of the manufacturer.

A written declaration specifying that the same application has not been filed with another notified body.

All relevant information about the type of pressure equipment in question.

The documentation for the quality system.

The technical documentation referred to in paragraph 2.

5.2 The quality system will ensure that the pressure equipment meets the requirements of this royal decree that apply to them.

All the elements, requirements and provisions adopted by the manufacturer shall be contained in a documentation carried out in a systematic and orderly manner in the form of measures, procedures and instructions, all in writing. The quality system documentation will allow for a uniform interpretation of quality programmes, plans, manuals and dossiers.

In particular, it will include an appropriate description of:

Quality objectives, organization chart and responsibilities and powers of management personnel as regards the quality of pressure equipment.

The corresponding techniques, processes and systematic actions of manufacture, quality assurance and quality assurance to be used, and in particular the procedures for the permanent union of the parts of the in accordance with paragraph 3.1.2 of Annex I.

Tests and tests that will be performed before, during, and after manufacturing and their frequency.

Quality dossiers, such as inspection reports, test and calibration data, reports on the qualification or approval of the staff concerned, and in particular the staff in charge of the union permanent of the parties in accordance with paragraph 3.1.2 of Annex I, etc.

The means by which the achievement of the quality of the product required and the effective functioning of the quality system are monitored.

5.3 The notified body shall evaluate the quality system to determine whether it meets the requirements referred to in paragraph 5.2. Those elements of the quality system which comply with the relevant harmonised standard shall be presumed to comply with the relevant requirements prescribed in paragraph 5.2.

In addition to experience in quality management systems, the team of auditors shall have at least one member who has experience in the assessment of the technology of the pressure equipment concerned, as well as knowledge on the applicable requirements of this royal decree. The audit shall include an assessment visit to the manufacturer's premises.

The audit team shall review the technical documentation referred to in paragraph 2 to check whether the manufacturer is able to identify the relevant requirements of this royal decree and to carry out the necessary examinations at the end of the ensure that the pressure equipment meets those requirements.

The decision will be notified to the manufacturer. The notification shall include the findings of the audit and the reasoned assessment decision.

5.4 The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it in a manner that continues to be appropriate and effective.

5.5 The manufacturer shall keep the notified body that has approved the quality system informed of any planned adaptation of that system.

The notified body shall assess the proposed adaptations and decide whether the modified quality system meets the requirements set out in paragraph 5.2 or if a new assessment is necessary.

You will notify the manufacturer of your decision. The notification shall include the findings of the examination and the reasoned assessment decision.

6. Surveillance under the responsibility of the notified body.

6.1 The purpose of the surveillance is to verify that the manufacturer duly fulfils the obligations imposed on him by the approved quality system.

6.2 The manufacturer shall allow the notified body to enter the premises of manufacture, inspection, testing and storage for the purpose of evaluation and shall provide it with all the necessary information, in particular:

The documentation for the quality system.

The technical documentation referred to in paragraph 2.

Quality dossiers, such as inspection reports, test and calibration data, reports on the qualification of affected staff, etc.

6.3 The notified body shall carry out periodic audits to ensure that the manufacturer maintains and applies the quality system and shall provide the manufacturer with an audit report. The frequency of periodic audits shall be established in such a way that a full reassessment is carried out every three years.

6.4 Furthermore, the notified body may make unexpected visits to the manufacturer. The need and frequency of these additional visits will be determined by a monitoring system of visits to be carried out by the notified body. The following factors shall be taken into account in the visit control system, in particular:

The category of the pressure equipment.

The results of previous surveillance visits.

The need to check compliance with corrective measures.

When applicable, special conditions related to system approval.

Significant modifications of the organization, policy, or manufacturing techniques.

In the course of such visits, the notified body may, if deemed necessary, carry out tests on the products in order to verify the proper functioning of the quality system. That body shall submit to the manufacturer a report of the visit and, if any test has been carried out, a report of the visit.

7. CE marking and EU declaration of conformity.

7.1 The manufacturer shall affix the CE marking and, under the responsibility of the notified body referred to in paragraph 5.1, the latter's identification number on each pressure equipment satisfying the applicable requirements. of this royal decree.

7.2 The manufacturer shall draw up an EU declaration of conformity for each pressure equipment model and keep it at the disposal of the national authorities for a period of 10 years from the introduction of the equipment to pressure on the market. The EU declaration of conformity shall identify the product model for which it has been drawn up.

A copy of the EU declaration shall be provided in accordance with the competent authorities upon request.

8. Preservation of documentation.

For a period of ten years from the introduction of the pressure equipment into the market, the manufacturer shall have at the disposal of the national authorities:

The documentation referred to in paragraph 5.1.

The adaptation referred to in section 5.5.

The decisions and reports of the notified body referred to in paragraphs 5.5, 6.3 and 6.4.

9. Reporting duties of the notified body.

Each notified body shall inform its notifying authority of the approvals of quality systems issued or withdrawn and shall, on a regular basis or upon request, make available to its notifying authority the list of quality system approvals that you have rejected, suspended, or otherwise restricted.

Each notified body shall inform the other notified bodies of quality system approvals which it has rejected, suspended or withdrawn and, upon request, of the quality system approvals which it has issued. issued.

10. Authorized representative.

The manufacturer's obligations referred to in paragraphs 3, 5.1, 5.5, 7 and 8 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in his mandate.

Module E

(Compliance with type based on quality assurance of pressure equipment)

1. Concept.

Conformity to the type based on quality assurance of the pressure equipment is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in the paragraphs 2 and 5, and ensures and declares, under its sole responsibility, that the pressure equipment in question is in conformity with the type described in the EU-type examination certificate and satisfies the requirements of this royal decree which apply to it.

2. Manufacturing.

The manufacturer shall manage an approved quality system for the inspection of the finished product and the tests of the pressure equipment in question, as specified in paragraph 3, and shall be subject to the surveillance referred to in paragraph 3. paragraph 4.

3. Quality system.

3.1 The manufacturer shall submit an application for the assessment of his quality system to the notified body of his choice, for the pressure equipment concerned.

This request will include:

The name and address of the manufacturer and, if the request is submitted by the authorized representative, the name and address of the manufacturer.

A written declaration specifying that the same application has not been filed with another notified body.

All relevant information about the type of pressure equipment in question.

The documentation for the quality system.

The technical documentation of the approved type and a copy of the EU type examination certificate.

3.2 The quality system shall ensure that the products are in conformity with the type described in the EU-type examination certificate and satisfy the requirements of this royal decree that apply to them.

All the elements, requirements and provisions adopted by the manufacturer shall be contained in a documentation carried out in a systematic and orderly manner in the form of measures, procedures and instructions, all in writing. The quality system documentation will allow for a uniform interpretation of quality programmes, plans, manuals and dossiers.

In particular, it will include an appropriate description of:

Quality objectives, organization chart, and responsibilities and powers of management personnel as regards the quality of the products.

Tests and tests to be performed after manufacture.

Quality dossiers, such as inspection reports, test and calibration data, reports on the qualification or approval of the staff concerned, and in particular the person responsible for the union permanent of the parts and the performance of the non-destructive tests in accordance with paragraphs 3.1.2 and 3.1.3 of Annex I.

The means by which the effective operation of the quality system is monitored.

3.3 The notified body shall evaluate the quality system to determine whether it meets the requirements referred to in paragraph 3.2. It shall, for alleged compliance with those requirements of the elements of the quality system, comply with the relevant specifications of the relevant harmonised standard.

In addition to experience in quality management systems, the team of auditors shall have at least one member who has experience in the assessment in the field and the technology of the pressure equipment concerned, as well as knowledge of the applicable requirements of this royal decree. The audit shall include an assessment visit to the manufacturer's premises.

The team of auditors shall review the technical documentation referred to in the fifth indent of paragraph 3.1 to check whether the manufacturer is capable of identifying the relevant requirements of this Royal Decree and of making the necessary tests to ensure that the pressure equipment meets those requirements.

The decision will be notified to the manufacturer. The notification shall include the findings of the audit and the reasoned assessment decision.

3.4 The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it in a manner that continues to be appropriate and effective.

3.5 The manufacturer shall keep the notified body that has approved the quality system informed of any planned adaptation of that system.

The notified body shall assess the proposed adaptations and decide whether the modified quality system is still in line with the requirements laid down in paragraph 3.2 or if a new assessment is necessary.

You will notify the manufacturer of your decision. The notification shall include the findings of the examination and the reasoned assessment decision.

4. Surveillance under the responsibility of the notified body.

4.1 The purpose of the surveillance is to verify that the manufacturer duly fulfils the obligations imposed on him by the approved quality system.

4.2 The manufacturer shall allow the notified body to enter the premises of manufacture, inspection, testing and storage for evaluation purposes and shall provide it with all the necessary information, in particular:

The documentation for the quality system.

The technical documentation.

Quality dossiers, such as inspection reports, test and calibration data, reports on the qualification of affected staff, etc.

4.3 The notified body shall carry out periodic audits to ensure that the manufacturer maintains and applies the quality system and shall provide the manufacturer with an audit report. The frequency of periodic audits shall be established in such a way that a full reassessment is carried out every three years.

4.4 Furthermore, the notified body may make unexpected visits to the manufacturer.

The need and frequency of these additional visits will be determined by a monitoring system that will be performed by the notified body. The following factors shall be taken into account in the visit control system, in particular:

The category of the pressure equipment.

The results of previous surveillance visits.

The need to check compliance with corrective measures.

When applicable, special conditions related to system approval.

Significant modifications of the organization, policy, or manufacturing techniques.

In the course of such visits, the notified body may, if deemed necessary, carry out tests on the products in order to verify the proper functioning of the quality system. That body shall submit to the manufacturer a report of the visit and, if any test has been carried out, a report of the visit.

5. CE marking and EU declaration of conformity.

5.1 The manufacturer shall affix the CE marking and, under the responsibility of the notified body referred to in paragraph 3.1, the latter's identification number on each pressure equipment conforming to the type described in paragraph 3.1. the EU type examination certificate and satisfy the applicable requirements of this royal decree.

5.2 The manufacturer shall draw up an EU declaration of conformity for each pressure equipment model and keep it at the disposal of the national authorities for a period of 10 years from the introduction of the equipment to pressure on the market. The EU declaration of conformity shall identify the product model for which it has been drawn up.

A copy of the EU declaration shall be provided in accordance with the competent authorities upon request.

6. Preservation of the documentation.

For a period of ten years from the introduction of the pressure equipment into the market, the manufacturer shall have at the disposal of the national authorities:

The documentation referred to in section 3.1.

The adaptation referred to in paragraph 3.5 that has been approved.

The decisions and reports of the notified body referred to in paragraphs 3.3, 3.5, 4.3 and 4.4.

7. Reporting duties of the notified body.

Each notified body shall inform its notifying authority of the approvals of quality systems issued or withdrawn and shall, on a regular basis or upon request, make available to its notifying authority the list of quality system approvals that you have rejected, suspended, or otherwise restricted.

Each notified body shall inform the other notified bodies of quality system approvals which it has rejected, suspended or withdrawn and, upon request, of the quality system approvals which it has issued. issued.

8. Authorized representative.

The manufacturer's obligations referred to in paragraphs 3.1, 3.5, 5 and 6 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in his mandate.

E1 Module

(Assurance of inspection quality and testing of finished pressure equipment)

1. Concept.

The quality assurance of the inspection and testing of the finished pressure equipment is the conformity assessment procedure whereby the manufacturer fulfils the obligations set out in paragraphs 2, 4 and 4. and 7, and guarantees and declares, under its sole responsibility, that the pressure equipment in question satisfies the requirements of this royal decree that apply to it.

2. Technical documentation.

The manufacturer will produce the technical documentation. The technical documentation shall allow the assessment of whether the pressure equipment meets the relevant requirements and shall include an appropriate risk assessment and assessment. The technical documentation shall specify the applicable requirements and shall, in so far as it is relevant for the assessment, design, manufacture and operation of the pressure equipment. The technical documentation shall include, where appropriate, at least the following elements:

A general description of the pressure equipment.

The design and manufacturing plans and the schemas of the components, subsets, circuits, etc.

The descriptions and explanations required for the understanding of such plans and schemes and the operation of the equipment under pressure.

A list of harmonised standards, applied in whole or in part, the references of which have been published in the Official Journal of the European Union and, where these harmonised standards have not been applied, the description of the solutions adopted to meet the essential safety requirements of this royal decree; in the case of harmonised standards which are applied in part, the parts that have been applied shall be specified in the technical documentation.

The results of the design calculations performed, the examinations performed, etc.

The reports on the trials.

3. Technical documentation.

The manufacturer shall keep the technical documentation at the disposal of the relevant national authorities for a period of 10 years from the introduction of the pressure equipment into the market.

4. Manufacturing.

The manufacturer shall manage an approved quality system for the inspection of the finished product and the tests of the pressure equipment in question, as specified in paragraph 5, and shall be subject to the surveillance referred to in paragraph 5. paragraph 6.

5. Quality system.

5.1 The manufacturer shall submit an application for the assessment of his quality system to the notified body of his choice, for the pressure equipment concerned.

This request will include:

The name and address of the manufacturer and, if the request is submitted by the authorized representative, the name and address of the manufacturer.

A written declaration specifying that the same application has not been filed with another notified body.

All relevant information about the type of pressure equipment in question.

The documentation for the quality system.

The technical documentation referred to in paragraph 2.

5.2 The quality system will ensure that the pressure equipment meets the requirements of this royal decree that apply to them.

In the context of the quality system, each pressure equipment shall be examined and the appropriate tests shall be carried out in accordance with the relevant standard or standards set out in Article 12, or other equivalent tests, and, the final assessment referred to in paragraph 3.2 of Annex I, in order to ensure compliance with the requirements of this royal decree which apply to it.

All the elements, requirements and provisions adopted by the manufacturer shall be contained in a documentation carried out in a systematic and orderly manner in the form of measures, procedures and instructions, all in writing. The quality system documentation will allow for a uniform interpretation of quality programmes, plans, manuals and dossiers.

In particular, it will include an appropriate description of:

Quality objectives, organization chart and responsibilities and powers of management personnel as regards the quality of pressure equipment.

The procedures for permanent union of the approved parts in accordance with paragraph 3.1.2 of Annex I.

Tests and tests to be performed after manufacture.

Quality dossiers, such as inspection reports, test and calibration data, reports on the qualification or approval of the staff concerned, and in particular the staff in charge of the union permanent of the parts in accordance with paragraph 3.1.2 of Annex I.

The means by which the effective operation of the quality system is monitored.

5.3 The notified body shall evaluate the quality system to determine whether it meets the requirements referred to in paragraph 5.2

You will be given the compliance with those requirements of the quality system elements that meet the corresponding specifications of the corresponding harmonised standard.

In addition to experience in quality management systems, the team of auditors will have at least one member who has experience in the field of pressure equipment assessment and pressure equipment technology. in question, as well as knowledge of the applicable requirements of this royal decree. The audit shall include an assessment visit to the manufacturer's premises.

The audit team shall review the technical documentation referred to in paragraph 2 to check whether the manufacturer is able to identify the relevant requirements of this royal decree and to carry out the necessary examinations at the end of the ensure that the pressure equipment meets those requirements.

The decision will be notified to the manufacturer. The notification shall include the findings of the audit and the reasoned assessment decision.

5.4 The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it in a manner that continues to be appropriate and effective.

5.5 The manufacturer shall keep the notified body that has approved the quality system informed of any planned adaptation of that system.

The notified body shall assess the proposed adaptations and decide whether the modified quality system is still in line with the requirements set out in paragraph 5.2 or if a new assessment is necessary.

You will notify the manufacturer of your decision. The notification shall include the findings of the examination and the reasoned assessment decision.

6. Surveillance under the responsibility of the notified body.

6.1 The purpose of the surveillance is to verify that the manufacturer duly fulfils the obligations imposed on him by the approved quality system.

6.2 The manufacturer shall allow the notified body to enter the premises of manufacture, inspection, testing and storage for the purpose of evaluation and shall provide it with all the necessary information, in particular:

The documentation for the quality system.

The technical documentation referred to in paragraph 2.

Quality dossiers, such as inspection reports, test and calibration data, reports on the qualification of affected staff, etc.

6.3 The notified body shall carry out periodic audits to ensure that the manufacturer maintains and applies the quality system and shall provide the manufacturer with an audit report. The frequency of periodic audits shall be established in such a way that a full reassessment is carried out every three years.

6.4 Furthermore, the notified body may make unexpected visits to the manufacturer. The need and frequency of these additional visits will be determined by a monitoring system of visits to be carried out by the notified body. The following factors shall be taken into account in the visit control system, in particular:

The category of the team.

The results of previous surveillance visits.

The need to check compliance with corrective measures.

When applicable, special conditions related to system approval.

Significant modifications of the organization, policy, or manufacturing techniques.

In the course of such visits, the notified body may, if deemed necessary, carry out tests on the products in order to verify the proper functioning of the quality system. That body shall submit to the manufacturer a report of the visit and, if any test has been carried out, a report of the visit.

7. CE marking and EU declaration of conformity.

7.1 The manufacturer shall affix the CE marking and, under the responsibility of the notified body referred to in paragraph 5.1, the latter's identification number on each pressure equipment satisfying the applicable requirements. of this royal decree.

7.2 The manufacturer shall draw up an EU declaration of conformity for each pressure equipment model and keep it at the disposal of the national authorities for a period of 10 years from the introduction of the equipment to pressure on the market. The EU declaration of conformity shall identify the model of pressure equipment for which it has been drawn up.

A copy of the EU declaration shall be provided in accordance with the competent authorities upon request.

8. Preservation of documentation.

For a period of ten years from the introduction of the pressure equipment into the market, the manufacturer shall have at the disposal of the national authorities:

The documentation referred to in paragraph 5.1.

The adaptation referred to in section 5.5 that has been approved.

The decisions and reports of the notified body referred to in paragraphs 5.3, 5.5, 6.3 and 6.4.

9. Reporting duties of the notified body.

Each notified body shall inform its notifying authority of the approvals of quality systems issued or withdrawn and shall, on a regular basis or upon request, make available to its notifying authority the list of quality system approvals that you have rejected, suspended, or otherwise restricted.

Each notified body shall inform the other notified bodies of quality system approvals which it has rejected, suspended or withdrawn and, upon request, of the quality system approvals which it has issued. issued.

10. Authorized representative.

The manufacturer's obligations referred to in paragraphs 3, 5.1, 5.5, 7 and 8 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in his mandate.

Module F

(Compliance with type based on pressure equipment verification)

1. Concept.

Compliance with the type based on the verification of the pressure equipment is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations set out in paragraphs 2 and 5, and ensures and declares, under its sole responsibility, that the pressure equipment in question, which complies with paragraph 3, is in conformity with the type described in the EU-type examination certificate and satisfies the requirements of this real decree that is applied to you.

2. Manufacturing.

The manufacturer shall take all necessary steps to ensure that the manufacturing process and its monitoring ensure the conformity of the products manufactured with the type described in the EU-type examination certificate and with the requirements of this royal decree that apply to them.

3. Verification.

A notified body chosen by the manufacturer shall carry out the relevant examinations and tests in order to verify the conformity of the pressure equipment with the approved type described in the EU-type examination certificate and the corresponding requirements of this royal decree.

Tests and tests to check the conformity of the equipment under pressure with the relevant requirements shall be carried out by examination and testing of each product as specified in paragraph 4.

4. Verification of conformity by examination and testing of each pressure equipment.

4.1 All pressure equipment shall be examined one by one and the appropriate tests defined in the harmonised standard or standards shall be carried out and/or equivalent tests shall be carried out to verify conformity with the approved type. described in the EU-type examination certificate and with the corresponding requirements of this royal decree. In the absence of such harmonised standards, the notified body concerned shall decide on the appropriate tests to be carried out.

In particular, the notified body:

Check whether the staff in charge of permanent union of the parties and the performance of the non-destructive tests have the qualification or approval referred to in paragraphs 3.1.2 and 3.1.3 of Annex I.

Check the certificate issued by the manufacturer of the material in accordance with paragraph 4.3 of Annex I.

perform or cause the final inspection and overload test provided for in paragraph 3.2 of Annex I to be carried out and, where appropriate, examine the safety devices.

4.2 The notified body shall issue a certificate of conformity concerning the examinations and tests carried out and shall affix its identification number to each approved pressure equipment, or make it placed under its control. responsibility.

The manufacturer shall keep the certificates of conformity available for inspection by the national authorities for a period of 10 years from the introduction of the pressure equipment into the market.

5. CE marking and EU declaration of conformity.

5.1 The manufacturer shall affix the CE marking and, under the responsibility of the notified body referred to in paragraph 3, the latter's identification number on each pressure equipment conforming to the approved type described in the EU-type examination certificate and satisfies the applicable requirements of this royal decree.

5.2 The manufacturer shall draw up an EU declaration of conformity for each pressure equipment model and keep it at the disposal of the national authorities for a period of 10 years from the introduction of the equipment to pressure on the market. The EU declaration of conformity shall identify the model of pressure equipment for which it has been drawn up.

A copy of the EU declaration shall be provided in accordance with the competent authorities upon request.

If the notified body referred to in paragraph 3 has agreed, the manufacturer shall also place the notified body's identification number under the responsibility of the notified body under the responsibility of the notified body.

6. The manufacturer may, if agreed by the notified body and under his responsibility, place the notified body's identification number on the equipment under pressure during the manufacturing process.

7. Authorized representative.

The manufacturer's obligations may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in his mandate. The authorised representative may not fulfil the manufacturer's obligations referred to in paragraph 2.

Module G

(Compliance based on unit verification)

1. Concept.

Compliance based on unit verification is the conformity assessment procedure whereby the manufacturer fulfils the obligations set out in paragraphs 2, 3 and 5, and ensures and declares, under his/her sole responsibility, which the pressure equipment in question, which complies with paragraph 4, is in accordance with the requirements of this royal decree which apply to it.

2. Technical documentation.

The manufacturer shall draw up the technical documentation and make it available to the notified body referred to in paragraph 4.

The documentation shall allow the assessment of the compliance of the pressure equipment with the relevant requirements and shall include an appropriate risk assessment and assessment. It shall specify the applicable requirements and shall, in so far as it is relevant for the assessment, design, manufacture and operation of the equipment under pressure.

The technical documentation shall include, where appropriate, at least the following elements:

A general description of the pressure equipment.

The design and manufacturing plans and the schemas of the components, subsets, circuits, etc.

The descriptions and explanations required for the understanding of such plans and schemes and the operation of the equipment under pressure.

A list of harmonised standards, applied in whole or in part, the references of which have been published in the Official Journal of the European Union and, where these harmonised standards have not been applied, the description of the solutions adopted to meet the essential safety requirements of this royal decree; in the case of harmonised standards which are applied in part, the parts that have been applied shall be specified in the technical documentation.

The results of the design calculations performed, the examinations performed, etc.

The reports on the trials.

The appropriate elements concerning the approval of the manufacturing and testing procedures and the qualification or approval of the staff concerned, in accordance with paragraphs 3.1.2 and 3.1.3 of Annex I.

The manufacturer shall keep the technical documentation at the disposal of the relevant national authorities for a period of 10 years from the introduction of the pressure equipment into the market.

3. Manufacturing.

The manufacturer shall take all necessary steps to ensure that the manufacturing process and its monitoring ensure the conformity of the manufactured pressure equipment with the applicable requirements of this royal decree.

4. Verification.

A notified body chosen by the manufacturer shall carry out appropriate examinations and tests as set out in the harmonised standards, and/or equivalent tests, to check the conformity of the equipment to be carried out by the manufacturer. pressure with the applicable requirements of this royal decree. In the absence of such harmonised standards, the notified body concerned shall decide on appropriate tests to be carried out using other technical specifications.

In particular, the notified body:

You will examine the technical documentation as it relates to the design and manufacturing procedures.

Evaluate the materials used when they are not in conformity with the applicable harmonised standards or with a European approval of pressure equipment materials, and shall verify the certificate issued by the manufacturer of the material, in accordance with the provisions of paragraph 4.3 of Annex I.

approve the parties ' permanent union methods or verify whether they have been approved in advance, in accordance with paragraph 3.1.2 of Annex I.

Verify the qualifications or approvals required under paragraphs 3.1.2 and 3.1.3 of Annex I.

The final inspection referred to in paragraph 3.2.1 of Annex I shall be carried out or performed by the test prescribed in paragraph 3.2.2 of Annex I and shall, where appropriate, examine the safety devices.

The notified body shall issue a certificate of conformity concerning the examinations and tests carried out and shall affix its identification number to each approved pressure equipment or make it placed under its responsibility. The manufacturer shall keep the certificates of conformity at the disposal of the national authorities for a period of 10 years from the introduction of the pressure equipment into the market.

5. CE marking and EU declaration of conformity.

5.1 The manufacturer shall affix the CE marking and, under the responsibility of the notified body referred to in paragraph 4, the latter's identification number on each pressure equipment which satisfies the applicable requirements of the present royal decree.

5.2 The manufacturer shall draw up an EU declaration of conformity and keep it at the disposal of the national authorities for a period of 10 years from the introduction of the pressure equipment into the market. The EU declaration of conformity shall identify the pressure equipment for which it has been drawn up.

A copy of the EU declaration shall be provided in accordance with the competent authorities upon request.

6. Authorized representative.

The manufacturer's obligations referred to in paragraphs 2 and 5 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in his mandate.

H Module

(Compliance based on full quality assurance)

1. Concept.

Conformity based on full quality assurance is the conformity assessment procedure whereby the manufacturer fulfils the obligations set out in paragraphs 2 and 5, and ensures and declares, under your sole responsibility, which the pressure equipment in question satisfies the requirements of this royal decree that apply to you.

2. Manufacturing.

The manufacturer shall manage an approved quality system for the design, manufacture, inspection of finished products and testing of the pressure equipment as specified in paragraph 3 and shall be subject to the surveillance referred to in paragraph 4.

3. Quality system.

3.1 The manufacturer shall submit an application for the assessment of his quality system to the notified body of his choice, for the pressure equipment concerned.

This request will include:

The name and address of the manufacturer and, if the request is submitted by the authorized representative, the name and address of the manufacturer.

The technical documentation for a model of each type of pressure equipment to be manufactured.

The technical documentation shall include, where appropriate, at least the following elements:

A general description of the pressure equipment.

The design and manufacturing plans and the schemas of the components, subsets, circuits, etc.

The descriptions and explanations required for the understanding of such plans and schemes and the operation of the equipment under pressure.

A list of harmonised standards, applied in whole or in part, the references of which have been published in the Official Journal of the European Union and, where these harmonised standards have not been applied, the description of the solutions adopted to meet the essential safety requirements of this Royal Decree; in the case of harmonised standards which are applied in part, the parts that have been applied shall be specified in the technical documentation.

The results of the design calculations performed, the examinations performed, etc.

The reports on the trials.

The documentation for the quality system.

A written declaration specifying that the same application has not been filed with another notified body.

3.2 The quality system will ensure that the pressure equipment meets the requirements of this royal decree that apply to them.

All the elements, requirements and provisions adopted by the manufacturer shall be contained in a documentation carried out in a systematic and orderly manner in the form of measures, procedures and instructions, all in writing. This quality system documentation will allow for a uniform interpretation of quality programmes, plans, manuals and dossiers.

In particular, it will include an appropriate description of:

Quality objectives, organization chart, and responsibilities and powers of management personnel as regards the design and quality of the product.

The technical specifications of the design, including the rules to be applied and, if the relevant harmonised standards do not apply in full, the means to be used to ensure compliance with the requirements. essential requirements of this royal decree which apply to pressure equipment.

The systematic techniques, processes and measures of control and design verification to be used when designing the pressure equipment belonging to the type of product concerned, in particular as regards the materials, in accordance with paragraph 4 of Annex I.

The corresponding techniques, processes and systematic actions of manufacture, quality control and quality assurance to be used, in particular the procedures for the permanent union of the parties, approved in accordance with paragraph 3.1.2 of Annex I.

Tests and tests that will be performed before, during, and after manufacturing and their frequency.

Quality dossiers, such as inspection reports, test and calibration data, reports on the qualification or approval of the staff concerned, and in particular the staff in charge of the union permanent of the parts and the performance of the non-destructive tests referred to in paragraphs 3.1.2 and 3.1.3 of Annex I, etc.

The means by which the achievement of the design and quality of the required pressure equipment and the effective functioning of the quality system are monitored.

3.3 The notified body shall evaluate the quality system to determine whether it meets the requirements referred to in paragraph 3.2. It shall, for alleged compliance with those requirements of the elements of the quality system, comply with the relevant specifications of the relevant harmonised standard.

In addition to experience in quality management systems, the team of auditors shall have at least one member who has experience as an evaluator of the pressure equipment technology in question, as well as knowledge on the applicable requirements of this royal decree. The audit shall include an assessment visit to the manufacturer's premises.

The team of auditors shall review the technical documentation referred to in the second indent of paragraph 1 to check whether the manufacturer is capable of identifying the relevant requirements of this Royal Decree and of making the necessary tests to ensure that the pressure equipment meets those requirements.

The decision shall be notified to the manufacturer or his authorised representative. The notification shall include the findings of the audit and the reasoned assessment decision.

3.4 The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it in a manner that continues to be appropriate and effective.

3.5 The manufacturer shall keep the notified body that has approved the quality system informed of any planned adaptation of that system.

The notified body shall assess the proposed adaptations and decide whether the modified quality system is still in line with the requirements laid down in paragraph 3.2 or if a new assessment is necessary.

You will notify the manufacturer of your decision. The notification shall include the findings of the examination and the reasoned assessment decision.

4. Surveillance under the responsibility of the notified body.

4.1 The purpose of the surveillance is to verify that the manufacturer duly fulfils the obligations imposed on him by the approved quality system.

4.2 The manufacturer shall allow the notified body's entry into the premises of design, manufacture, inspection, testing and storage for evaluation purposes and shall provide it with all the necessary information, in particular:

The documentation for the quality system.

The quality records foreseen in the part of the quality system dedicated to the design, such as the results of the analyses, the calculations, the tests, etc.

The quality records provided for in the part of the quality system dedicated to manufacturing, such as inspection reports, test and calibration data, reports on the qualification of the staff concerned, etc.

4.3 The notified body shall carry out periodic audits to ensure that the manufacturer maintains and applies the quality system and shall provide the manufacturer with an audit report. The frequency of periodic audits shall be established in such a way that a full reassessment is carried out every three years.

4.4 Furthermore, the notified body may make unexpected visits to the manufacturer.

The need and frequency of these additional visits will be determined by a monitoring system that will be performed by the notified body. The following factors shall be taken into account in the visit control system, in particular:

The category of the team.

The results of previous surveillance visits.

The need to check compliance with corrective measures.

When applicable, special conditions related to system approval.

Significant modifications of the organization, policy, or manufacturing techniques.

In the course of such visits, the notified body may, if deemed necessary, carry out tests on the products in order to verify the proper functioning of the quality system. That body shall submit to the manufacturer a report of the visit and, if any test has been carried out, a report of the visit.

5. CE marking and EU declaration of conformity.

5.1 The manufacturer shall affix the CE marking and, under the responsibility of the notified body referred to in paragraph 3.1, the latter's identification number on each pressure equipment satisfying the applicable requirements. of this royal decree.

5.2 The manufacturer shall draw up an EU declaration of conformity for each pressure equipment model and keep it at the disposal of the national authorities for a period of 10 years from the introduction of the equipment to pressure on the market. The EU declaration of conformity shall identify the model of pressure equipment for which it has been drawn up.

A copy of the EU declaration shall be provided in accordance with the competent authorities upon request.

6. Preservation of documentation.

For a period of ten years from the introduction of the pressure equipment into the market, the manufacturer shall have at the disposal of the national authorities:

The technical documentation referred to in paragraph 3.1.

The quality system documentation referred to in section 3.1.

The adaptation referred to in paragraph 3.4 that has been approved.

The decisions and reports of the notified body referred to in paragraphs 3.3, 3.4, 4.3 and 4.4.

7. Reporting duties of the notified body.

Each notified body shall inform its notifying authority of the approvals of quality systems issued or withdrawn and shall, on a regular basis or upon request, make available to its notifying authority the list of quality system approvals that you have rejected, suspended, or otherwise restricted.

Each notified body shall inform the other notified bodies of quality system approvals which it has rejected, suspended or withdrawn and, upon request, of the quality system approvals which it has issued. issued.

8. Authorised representative

The manufacturer's obligations referred to in paragraphs 3.1, 3.5, 5 and 6 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in his mandate.

H1 Module

(Compliance based on full quality assurance plus design review)

1. Concept.

Compliance based on full quality assurance plus examination of the design and special monitoring of the final assessment is the conformity assessment procedure whereby the manufacturer complies with the obligations set out in paragraphs 2 and 6, and ensures and declares, under its sole responsibility, that the pressure equipment concerned satisfies the requirements of the Directive that apply to them.

2. Manufacturing.

The manufacturer shall manage an approved quality system for the design and manufacture, as well as for the inspection of the finished products and the tests of the products in question, as specified in paragraph 3, and shall be subject to the surveillance referred to in paragraph 5. The adequacy of the technical design of the pressure equipment shall have been examined in accordance with the provisions of paragraph 4.

3. Quality system.

3.1 The manufacturer shall submit an application for the assessment of his quality system to the notified body of his choice, for the pressure equipment concerned.

This request will include:

The name and address of the manufacturer and, if the request is submitted by the authorized representative, the name and address of the manufacturer.

The technical documentation for a model of each type of pressure equipment to be manufactured.

The technical documentation shall include, where appropriate, at least the following elements:

A general description of the pressure equipment.

The design and manufacturing plans and the schemas of the components, subsets, circuits, etc.

The descriptions and explanations required for the understanding of such plans and schemes and the operation of the equipment under pressure.

A list of harmonised standards, applied in whole or in part, the references of which have been published in the Official Journal of the European Union and, where these harmonised standards have not been applied, the description of the solutions adopted to meet the essential safety requirements of this Royal Decree; in the case of harmonised standards which are applied in part, the parts that have been applied shall be specified in the technical documentation.

The results of the design calculations performed, the examinations performed, etc.

The reports on the trials.

The documentation for the quality system.

A written declaration specifying that the same application has not been filed with another notified body.

3.2 The quality system will ensure that the pressure equipment meets the requirements of this royal decree that apply to them.

All the elements, requirements and provisions adopted by the manufacturer shall be contained in a documentation carried out in a systematic and orderly manner in the form of measures, procedures and instructions, all in writing. The quality system documentation will allow for a uniform interpretation of quality programmes, plans, manuals and dossiers.

In particular, it will include an appropriate description of:

Quality objectives, organization chart, and responsibilities and powers of management personnel as regards the design and quality of the product.

The technical specifications for design, including the rules to be applied as well as, if the relevant harmonised standards are not to be fully implemented, the means with which compliance with the requirements will be ensured. essential security requirements of the present royal decree applicable to pressure equipment.

The design verification and control techniques, processes and systematic measures to be used when designing the pressure equipment belonging to the type of pressure equipment in question, in particular as regards refers to the materials in accordance with paragraph 4 of Annex I.

The corresponding techniques, processes and systematic actions of manufacture, quality control and quality assurance to be used, in particular the procedures for the permanent union of the parties, approved in accordance with paragraph 3.1.2 of Annex I.

Tests and tests that will be performed before, during, and after manufacturing and their frequency.

Quality dossiers, such as inspection reports, test and calibration data, reports on the qualification or approval of the staff concerned, in particular the staff in charge of the union permanent of the parts and the performance of the non-destructive tests in accordance with paragraphs 3.1.2 and 3.1.3 of Annex I, etc.

The means by which the achievement of the design and quality of the required pressure equipment and the effective functioning of the quality system are monitored.

3.3 The notified body shall evaluate the quality system to determine whether it meets the requirements referred to in paragraph 3.2

It shall for alleged compliance with those requirements of the elements of the quality system comply with the corresponding specifications of the relevant harmonised standard. In addition to experience in quality management systems, the team of auditors shall have at least one member who has experience as an evaluator in the field of pressure equipment and the technology of the pressure equipment in question. as knowledge of the applicable requirements of this royal decree. The audit shall include an assessment visit to the manufacturer's premises.

The audit team shall review the technical documentation referred to in the second indent of paragraph 3.1 to check whether the manufacturer is capable of identifying the relevant requirements of this Royal Decree and to carry out the necessary tests to ensure that the pressure equipment meets those requirements.

The decision will be notified to the manufacturer or his authorized representative.

The notification shall include the findings of the audit and the reasoned assessment decision.

3.4 The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it in a manner that continues to be appropriate and effective.

3.5 The manufacturer shall keep the notified body that has approved the quality system informed of any planned adaptation of that system.

The notified body shall assess the proposed adaptations and decide whether the modified quality system is still in line with the requirements laid down in paragraph 3.2 or if a new assessment is necessary.

You will notify the manufacturer of your decision. The notification shall include the findings of the examination and the reasoned assessment decision.

3.6 Each notified body shall inform its notifying authority of the approvals of quality systems issued or withdrawn and shall, on a regular basis or upon request, make available to its notifying authority the list of quality system approvals that you have rejected, suspended, or otherwise restricted.

Each notified body shall inform the other notified bodies of quality system approvals which it has rejected, suspended or withdrawn and, upon request, of the quality system approvals which it has issued. issued.

4. Examination of the design.

4.1 The manufacturer shall submit to the notified body referred to in paragraph 3.1 an application for examination of the design of each pressure equipment whose design has not been the subject of an earlier examination.

4.2 The application will make it possible to understand the design, manufacture and operation of the equipment under pressure and to assess compliance with the requirements of this royal decree. Such request shall include:

The name and address of the manufacturer.

A written declaration specifying that the same application has not been filed with another notified body.

The technical documentation. The documentation shall allow the assessment of whether the pressure equipment meets the relevant requirements and shall include an appropriate risk assessment and assessment. It shall specify the applicable requirements and shall include, in so far as it is relevant for such assessment, the design and operation of the pressure equipment.

The technical documentation shall include, where appropriate, at least the following elements:

A general description of the pressure equipment.

The design and manufacturing plans and the schemas of the components, subsets, circuits, etc.

The descriptions and explanations required for the understanding of such plans and schemes and the operation of the equipment under pressure.

A list of harmonised standards, applied in whole or in part, the references of which have been published in the Official Journal of the European Union and, where these harmonised standards have not been applied, the description of the solutions adopted to meet the essential safety requirements of this Royal Decree; in the case of harmonised standards which are applied in part, the parts that have been applied shall be specified in the technical documentation.

The results of the design calculations performed, the examinations performed, etc.

The reports on the trials.

The documentation supporting the adequacy of the technical design. These supporting evidence shall mention any document which has been used, in particular where the relevant harmonised standards have not been applied in full, and shall include, if necessary, the results of the tests carried out by the the competent laboratory of the manufacturer or by another laboratory which has carried out the tests on its behalf and under its responsibility.

4.3 The notified body shall examine the application and if the design meets the requirements of this royal decree applicable to the pressure equipment, it shall issue an EU design examination certificate to the manufacturer. This certificate shall include the name and address of the manufacturer, the conclusions of the examination, the conditions of validity (where applicable) and the data necessary to identify the approved design. One or more Annexes may be attached to the certificate.

The certificate and its annexes shall contain all relevant information to assess the conformity of the manufactured products with the design examined and to allow the control in service, where appropriate.

If the design does not satisfy the applicable requirements of this royal decree, the notified body shall refuse to issue a design examination certificate and shall inform the applicant accordingly, explaining in detail its negative.

4.4 The notified body shall be kept informed of changes in the generally recognised state of the art which indicate that the approved design can no longer meet the applicable requirements of this royal decree, and shall determine if such changes require further investigation. In that case, the notified body shall inform the manufacturer accordingly.

The manufacturer shall keep the notified body that has issued the EU design examination certificate informed of any modifications to the approved design that may affect compliance with the essential requirements of the actual decree or the conditions of validity of the certificate. Such modifications require additional approval-from the notified body that has issued the EU design examination certificate-in the form of addition to the original EU design examination certificate.

4.5 Each notified body shall inform its notifying authority of the EU design examination certificates and/or any additions thereto it has issued or withdrawn, and shall, on a regular basis or on request, put the the list of certificates and/or additions thereto which it has rejected, suspended or otherwise restricted, is available to its notifying authority.

Each notified body shall inform the other notified bodies of the EU design examination certificates and/or any additions thereto which it has rejected, withdrawn, suspended or otherwise restricted and, after request, on those certificates and/or any additions thereto that you have issued.

The Commission, the Member States and the other notified bodies may, on request, obtain a copy of the EU design examination certificates or their additions. Upon request, the Commission and the Member States may obtain a copy of the technical documentation and the results of the examinations carried out by the notified body.

The notified body shall be in possession of a copy of the EU design examination certificate, its annexes and additions, as well as the technical file containing the documentation submitted by the manufacturer until the end of the validity of that certificate.

4.6 The manufacturer shall keep at the disposal of the national authorities a copy of the EU design examination certificate, its annexes and its additions, as well as the technical documentation, for a period of 10 years from the date of introduction of the equipment under pressure in the market.

5. Surveillance under the responsibility of the notified body.

5.1 The purpose of the surveillance is to verify that the manufacturer duly fulfils the obligations imposed on him by the approved quality system.

5.2 The manufacturer shall allow the notified body's entry into the premises of design, manufacture, inspection, testing and storage for evaluation purposes and shall provide it with all the necessary information, in particular:

The documentation for the quality system.

The quality records foreseen in the part of the quality system dedicated to the design, such as analysis results, calculations, tests, etc.

The quality records provided for in the part of the quality system dedicated to manufacturing, such as inspection reports, test and calibration data, reports on the qualification of the staff concerned, etc.

5.3 The notified body shall carry out periodic audits to ensure that the manufacturer maintains and applies the quality system and shall provide the manufacturer with an audit report. The frequency of periodic audits shall be established in such a way that a full reassessment is carried out every three years.

5.4 Furthermore, the notified body may make unexpected visits to the manufacturer.

The need and frequency of these additional visits will be determined by a monitoring system that will be performed by the notified body. The following factors shall be taken into account in the visit control system, in particular:

The category of the team.

The results of previous surveillance visits.

The need to check compliance with corrective measures.

When applicable, special conditions related to system approval.

Significant modifications of the organization, policy, or manufacturing techniques.

In the course of such visits, the notified body may, if deemed necessary, carry out tests on the products in order to verify the proper functioning of the quality system. That body shall submit to the manufacturer a report of the visit and, if any test has been carried out, a report of the visit.

5.5 Special monitoring of the final evaluation.

The final assessment referred to in paragraph 3.2 of Annex I shall be subject to enhanced surveillance consisting of unannounced visits by the notified body. In the course of such visits the notified body shall carry out examinations of the pressure equipment.

This body shall submit a report to the manufacturer and, if any test has been carried out, a report of the visit.

6. CE marking and EU declaration of conformity

6.1 The manufacturer shall affix the CE marking and, under the responsibility of the notified body referred to in paragraph 3.1, the latter's identification number on each pressure equipment satisfying the applicable requirements. of this royal decree.

6.2 The manufacturer shall draw up an EU declaration of conformity for each pressure equipment model and keep it at the disposal of the national authorities for a period of 10 years from the introduction of the equipment to pressure on the market. The EU declaration of conformity shall identify the model of the pressure equipment for which it has been drawn up and the number of the design examination certificate shall be mentioned.

A copy of the EU declaration shall be provided in accordance with the competent authorities upon request.

7. Preservation of documentation.

For a period of ten years from the introduction of the pressure equipment into the market, the manufacturer shall have at the disposal of the national authorities:

The quality system documentation referred to in section 3.1.

The adaptation referred to in paragraph 3.5 that has been approved.

The decisions and reports of the notified body referred to in paragraphs 3.5, 5.3 and 5.4.

8. Authorized representative.

The manufacturer's authorised representative may submit the application referred to in paragraphs 4.1 and 4.2 and fulfil the obligations referred to in paragraphs 3.1, 3.5, 4.4, 4.6, 6 and 7 on his behalf and under his/her name. responsibility, as long as they are specified in your command.

ANNEX IV

EU Declaration of Conformity (n. º xxxx)1

1. Pressure equipment or assembly (product number, type, batch or series).

2. Name and address of the manufacturer and, where applicable, his authorised representative.

3. This declaration of conformity is issued under the sole responsibility of the manufacturer.

4. Purpose of the declaration (identification of the pressure equipment or assembly allowing traceability; if necessary for the identification of the pressure equipment or assembly, an image may be included):

Description of the team under pressure or set.

Procedure used for conformity assessment.

For sets, description of the pressure equipment that make up the set and indication of the procedure used for conformity assessment.

5. The purpose of the statement described above is in accordance with the relevant Union harmonisation legislation.

6. References to the relevant harmonised standards used or references to the other technical specifications for which conformity is declared.

7. Where appropriate, the name, address and number of the notified body which carried out the conformity assessment and the certificate number issued, and a reference to the EU-type examination certificate-type of production, to the certificate of EU-type examination-type of design, EU design examination certificate, or certificate of conformity.

8. Additional information.

Signed by and on behalf of:

(Place and date of issue):

(Name, charge) (signature):

(If applicable, identification of the signatory authorised to sign the legally binding declaration for the manufacturer or his authorised representative)

1 The manufacturer may give an optional number to the compliance declaration.