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.

Read the untranslated law here: http://www.boe.es/buscar/doc.php?id=BOE-A-2015-9527

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 Directive 97/23 / EC has been repealed with effect from July 19, 2016, by Article 50 of Directive 2014/68 / EU of the European Parliament and of the Council of 15 May 2014 on the harmonization of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

In compliance with the obligations under the Treaty of Accession of Spain to the European Union and the provisions of Article 49 of the Directive 2014/68 / EU of the European Parliament and of the Council of 15 May 2014 it is necessary to issue national provisions adapting Spanish legislation to the provisions contained in the above directive.

The new Directive 2014/68 / EU of the European Parliament and of the Council of 15 May 2014, makes a recast of 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:

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 Decision 93/465 repealing / EEC lays down common principles and reference provisions applicable to all sectoral legislation in order to provide a coherent basis for revision or recasts of that legislation.

B) Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labeling and packaging of substances and mixtures, amending and repealing Directives 67/548 / EEC and 1999/45 / EC and Regulation (EC) No 1907/2006 is amended, incorporates provisions hazard classification of 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 marketing of related products and Regulation (EEC) No 339/93 repealing rules on the accreditation of bodies conformity assessment, provides a framework for market surveillance of products and for controls on products from third countries and lays down the general principles of the CE marking.

This royal decree establishes the essential requirements applicable to pressure equipment and assemblies which constitute a novelty in the market of the European Union at the time of entering the same security; ie, that either is pressure equipment or new sets manufactured by a manufacturer established in the European Union, or are pressure equipment or assemblies, new or second-hand, imported from a third country.

Conformity with these essential safety requirements is necessary to ensure the safety of pressure equipment and assemblies. These requirements may be general for all equipment and assemblies, and specific only for some. In particular, the specific requirements of certain pressure equipment in categories III and IV, which will be subject to a final assessment comprising final inspection and testing apply.

To facilitate the assessment of compliance with these requirements, a presumption of conformity to pressure equipment or assemblies designed and manufactured according to the harmonized standards adopted under Regulation (EU states ) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardization, to set detailed technical specifications of these requirements, especially as regards the design, manufacturing and testing equipment pressure or sets.

In view of the nature of the risks posed by the use of pressure equipment and assemblies and for economic operators and competent authorities can demonstrate and ensure that the pressure equipment or assemblies marketed meet the essential requirements safety procedures conformity assessment are established. These procedures vary depending on the degree of danger inherent pressure equipment or assemblies. Therefore, for each category of pressure equipment is available an appropriate procedure or a choice between different procedures of equivalent stringency.


To do this, modules procedures conformity assessment are set, the less stringent the most stringent, in proportion to the level of risk and the level of safety required. To ensure cross-sectoral consistency and avoid variants 'ad hoc' procedures conformity assessment should be chosen from among those modules. The details added to these procedures are justified by the nature of the verification required for pressure equipment.

On the other hand, it is essential that all control agencies and all independent entities perform their functions conformity assessment at the same level and under conditions of fair competition. Consequently, mandatory requirements that must meet the watchdogs and independent entities wishing to be notified to the European Commission and the other Member States to provide services for conformity assessment are established.

May be notified only those who have previously obtained their accreditation. The accreditation system is an essential means of verifying the competence of inspection bodies. A transparent accreditation, to ensure the necessary level of confidence in conformity certificates, is considered as the preferred means of demonstrating the technical competence of these control bodies and independent entities.

During the pendency of this royal decree has made the hearing procedure provided for in Article 24.1.c) of Law 50/1997, of 27 November, the Government, the entities representing the sectors concerned. They have also been consulted autonomous regions and has obtained the mandatory report of the Coordinating Council of Industrial Safety in accordance with Article 18.4.c) of Law 21/1992 of 16 July, of Industry.

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

This provision is issued under the provisions of Article 149.1.13 of the Spanish Constitution, which grants the State competence to determine the bases and coordination of general planning of economic activity, notwithstanding the powers of the Autonomous Communities on the industry.

By virtue of the proposal of the Minister of Industry, Energy and Tourism, according to the Council of State and after deliberation by the Council of Ministers at its meeting on July 24, 2015,

DECREE:
CHAPTER
I
General provisions


Article 1. Purpose and scope.

1. The object of this royal decree establishing the essential requirements applicable to pressure equipment and assemblies involving a novelty in the market of the European Union at the time of entering the same for marketing security, order to ensure a high level of protection of health and safety of persons and protection of domestic animals and property.

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

2. This royal decree applies to the design, manufacture and conformity assessment of pressure equipment and assemblies with a maximum allowable pressure PS greater than 0.5 bar.

3. They are excluded from the scope of this Royal Decree:

3.1 pipelines comprising piping or a system of piping designed for the conveyance of any fluid or substance to an installation (onshore or offshore) or from it, since the last isolation device located within the confines of the installation, including device and all the annexed equipment designed specifically for pipelines. This exclusion does not apply to standard pressure equipment such as those found in decompression stations or compression stations.
3.2
networks for the supply, distribution and discharge of water as well as their equipment and water pipes motive as penstocks, pressure tunnels or galleries load for hydroelectric installations and their related specific accessories.
3.3
simple pressure vessels covered by Directive 2014/29 / EU of the European Parliament and of the Council of 26 February 2014 on the harmonization of the laws of the Member States concerning marketing vessels simple pressure.

3.4
aerosol dispensers regulated by Royal Decree 1381/2009, of 28 August, the requirements for the manufacture and marketing of aerosol generators are established.
3.5
equipment intended for the functioning of vehicles defined by the following rules:

I) Royal Decree 750/2010, of June 4, by which approval procedures for motor vehicles and their trailers, self-propelled or towed machinery, agricultural vehicles are regulated, as well as systems, parts and pieces 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 market surveillance of such vehicles.

Iii) Regulation (EU) No 168/2013 of the European Parliament and of the Council of 15 January 2013 concerning the approval of vehicles with two or three wheels and quadricycles, and market surveillance of such vehicles.
3.6
equipment classified as maximum category I in accordance with Article 13 of the Royal Decree and are covered by any of the following standards:

I) Royal Decree 1644/2008, of 10 October, laying down rules for the marketing and commissioning of the machines are set.

Ii) Directive 2014/33 / EU of the European Parliament and of the Council of 26 February 2014 on the harmonization 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 harmonization of the laws of the Member States of commercialization of electrical equipment designed for use within certain voltage limits.

Iv) Royal Decree 414/1996 of 1 March, which regulates medical devices.

V) Royal Decree 1428/1992, of 27 November, laying down rules for the application of the Council Directive of the European Communities 90/396 / EEC of 29 June on the approximation of dictate laws of the Member States relating to gas appliances.

Vi) Directive 2014/34 / EU of the European Parliament and of the Council of 26 February 2014 on the harmonization of the laws of the Member States concerning equipment and protective systems intended for use in potentially explosive atmospheres.
3.7
equipment referred to in Article 346.1.b) of the Treaty on the Functioning of the European Union (TFEU).
3.8
items specifically designed for nuclear use, failure of which may cause radioactive emissions.
3.9
well control equipment used in industry exploration and extraction of oil, gas or geothermal underground storage, designed to contain or control well pressure. These teams include the wellhead (Christmas tree), the blow-out preventer devices ( "Blow-out preventer" BOP), the piping manifolds and all their equipment upstream.

3.10 Equipment containing coatings or machinery where the dimensioning, choice of material and manufacturing rules are based primarily on requirements for sufficient strength, rigidity and stability to meet the static and dynamic performance or other features related to its operation and effects for which pressure is not a significant design factor. Such equipment may include:

I) engines including turbines and internal combustion engines.

Ii) The steam engines, gas turbines and steam turbine generators, compressors, pumps and actuating devices.

3.11 blast furnaces, with their cooling systems, hot blast recuperators, dust extractors and exhaust gas scrubbers blast furnace and direct reduction cupolas, with their cooling systems, converters gas and pans for melting, smelting, gassing and casting of steel, iron and non-ferrous metals.

3.12 envelopes electrical high voltage equipment such as switchgear, control gear, transformers, and rotating machines.

3.13 pressurized pipes for the elements of transmission systems, for example, electrical power and telephone cables.

3.14 ships, rockets, aircraft and mobile off-shore units, as well as equipment specifically intended for installation on board or the propulsion thereof.

3.15
pressure equipment consisting of a flexible casing, eg tires, cushions (mattresses) air, the balls used for play, inflatable craft, and other similar pressure equipment.

3.16 mufflers and intake.

3.17 bottles or cans for carbonated drinks for final consumption.

3.18 vessels designed for the transport and distribution of drinks having a PS x V does not exceed 500 bar per liter and a maximum allowable pressure not exceeding 7 bar.
3.19
regulated by the ADR (European Agreement concerning the international carriage of dangerous goods by road), RID (Regulations concerning the International Carriage of Dangerous Goods by Rail), IMDG (International Maritime Dangerous Goods Code) equipment and ICAO (international civil aviation Convention) and by Royal Decree 97/2014 of 14 February, the operations of transport of dangerous goods by road in Spanish territory and Royal Decree 1388/2011 regulates, of October 14, laying down rules implementing Directive 2010/35 / EU of the European Parliament and of the Council of 16 June 2010 on transportable pressure equipment are held and by repealing Directives 76/767 / EEC, 84/525 / EEC, 84/526 / EEC, 84/527 / EEC and 1999/36 / EC.

3.20 The radiators and pipes in heating systems for hot water.

3.21 vessels designed to contain liquids with a 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: vessels, piping, safety accessories and pressure accessories. In his case be considered as part of pressure equipment includes elements attached to pressurized parts, such as flanges, nozzles, couplings, supports, lifting lugs, etc.

2. Container: A cover designed and built to contain fluids under pressure including its direct attachments to the device intended for connection with other equipment. A container may consist of more than one camera.

3. Piping: piping components intended for the transport of fluids, when connected together for integration into a pressure system. Piping includes in particular a pipe or system of pipes, tubing, fittings, expansion joints, hoses or, where appropriate, other elements resistant to pressure. As equivalent to piping heat exchangers consisting of pipes and purpose of cooling or heating air.

4. Safety accessories: devices designed to protect pressure equipment against exceeding the allowable limits. These devices include:

I) devices for direct pressure limitation, such as safety valves, safety devices rupture discs, buckling rods and targeted safety devices (CSPRS).

Ii) limiting devices which activate the means for correction or provide for shutdown or shutdown and lockout, such as pressure switches driven by temperature or fluid level and devices' measurement, control and regulation having a security function (SRMCR). "

5. Pressure accessories: devices for operational purposes whose cover is under pressure.

6. Sets: several pressure equipment assembled by a manufacturer to constitute a functional whole.

7. Pressure: the pressure relative to atmospheric pressure, ie gauge pressure. Accordingly, the vacuum is designated by a negative value.

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

Will be defined in a place specified by the manufacturer, must be the location of connection of protective devices or safety or the top of equipment or if that is not appropriate any location specified.

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

10. Volume (V): the internal volume of a chamber, including the volume of nozzles to the first connection or weld and excluding the volume of permanent internal parts.


11. nominal diameter (DN): an identifying number so common diameter to all elements of a piping system other than components indicated by outside diameters or by thread size; Is a convenient round reference purposes only loosely related to manufacturing dimensions number. It is designated by DN followed by a number.

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

13. Permanent joints: joints which can be separated by destructive methods.

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

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

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

17. Commissioning: the first use of pressure equipment or set by the user.

18. Manufacturer: any natural or legal person who manufactures or designed or manufactured pressure equipment or set and marketed under his name or trademark or uses for its own purposes.

19. Authorized Representative means any natural or legal person established in the European Union who has received a written mandate from a manufacturer to act on his behalf for specified tasks.

20. Importer means any natural or legal person established in the European Union who pressure equipment or assemblies from a third country on the market of the European Union.

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

22. Economic agents: the manufacturer, the authorized representative, the importer and distributor.

23. Technical Specification: a document in which the technical requirements of the pressure equipment or assemblies are defined.

24. harmonized standard harmonized standard within the meaning of Article 2, paragraph 1, letter c) of Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardization by amending 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 amending Decision 87/95 / EEC repealing and decision No 1673/2006 / EC of the European Parliament and the Council.

25. Accreditation: accreditation as defined in Article 2, Item 10 of Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 establishing accreditation requirements are established and market surveillance relating to the marketing of products and Regulation (EEC) No 339/93 is repealed.

26. national accreditation body: national accreditation body within the meaning of Article 2 point 11 of Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 with

27. Conformity assessment: the process by which assesses whether the essential safety requirements of this Royal Decree regarding pressure equipment or assemblies are satisfied.

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

29. Recovery: any measure aimed at achieving the return of pressure equipment or assemblies and made available to consumers or other users.

30. Withdrawal means any measure aimed at preventing pressure equipment or assemblies which are in the supply chain.

31. the marking by which the manufacturer indicates that the pressure equipment or assembly comply with the applicable requirements of harmonization legislation of the European Union establishing the placement of the marking: CE marking.

32. Harmonization legislation of the European Union: all European Union legislation harmonizing the conditions for the marketing of products.


33. Control bodies notified: those which comply with Royal Decree 2200/1995, of 28 December, Regulation of infrastructure for industrial quality and safety approved and Article 21 of this Royal Decree, and are notified to the European Commission and the other Member States to carry out tasks conformity assessment as referred to in articles 14 and 15.

34. independent entities: those that meet the provisions of Royal Decree 2200/1995, of December 28, and Article 21 of the Royal Decree, and be notified to the European Commission and the other Member States to carry out those tasks envisaged in paragraphs 3.1.2 and 3.1.3 of Annex I.

Article 3. Marketing and commissioning.

1. may only be marketed and put into service pressure equipment and assemblies referred to in Article 1, if not jeopardize the safety or health of persons and, where appropriate, domestic animals or property, including the environment when properly installed and maintained and used in accordance with its intended use and meet the requirements of this royal decree.

2. The provisions of the Royal Decree This shall be without prejudice to national and regional legislation enacted to ensure the protection of persons and in particular workers using pressure equipment or assemblies in question, provided this does not involve modifications thereof in a manner not specified in the royal decree.

3. Be allowed with At trade fairs, exhibitions, demonstrations and other similar events, pressure equipment or assemblies as defined in Article 1 which do not comply with the provisions of this royal decree, provided it clearly indicates arise, a visible sign their non-conformity and therefore such equipment and assemblies can not be marketed or put into service until they are compliant. During demonstrations shall be taken in accordance with the requirements established by the Autonomous Communities, appropriate security measures to ensure the protection and safety of persons.

Article 4. Technical requirements.

1. Pressure equipment listed below must meet the essential safety requirements set out in Annex I:

1.1 Vessels, except those referred to in paragraph 1.2 for:

A) gases, liquefied gases, gases dissolved under pressure, vapors and liquids whose vapor pressure at the maximum allowable temperature is greater than 0,5 bar above normal atmospheric pressure (1,013 mbar), within the limits following:

A.1) For fluids in Group 1 of Article 13, those with a volume (V) greater than 1 liter (L) and a product of PS × V is greater than 25 bar × liter, as well as those with a pressure PS greater than 200 bar (Annex II, table 1).

A.2) For fluids in Group 2 of Article 13, those with a volume exceeding 1 liter and having a PS · × V is greater than 50 bar × liter, which with a pressure PS greater than 1000 bar, and all portable and bottles for breathing apparatus (Annex II, table 2) fire extinguishers.

B) Liquids whose vapor pressure at the maximum allowable temperature is less than or equal to 0.5 bar above normal atmospheric pressure (1,013 mbar) within the following limits:

B.1) For fluids in Group 1 of Article 13, those with a volume exceeding 1 liter and a product of PS × V exceeds 200 bar × liter, as well as those with a pressure PS greater than 500 bar (table 3 of Annex II).

B.2) For fluids in Group 2 of Article 13, those with a pressure PS greater than 10 bar and the product of PS x V exceeds 10,000 bar × liter, as well as those with a pressure PS greater than 1,000 bar (Annex II, table 4).

1.2 Pressure equipment subject to the action of a flame or heat input representing a risk of overheating intended for generation of steam or superheated water at temperatures above 110 ° C, with a higher volume 2 liters, and all pressure cookers (Annex II, table 5).
Pipes for 1.3
:

A) gases, liquefied gases, gases dissolved under pressure, vapors and liquids whose vapor pressure at the maximum allowable temperature is greater than 0,5 bar above normal atmospheric pressure (1,013 mbar), within the limits following:

A.1) for fluids in Group 1 with a DN greater than 25 (Table 6 of Annex II).


A.2) for fluids in Group 2 with a DN greater than 32 and the product of PS x DN greater than 1,000 bar (Annex II, table 7).

B) Liquids whose vapor pressure at the maximum allowable temperature is less than or equal to 0.5 bar above normal atmospheric pressure (1,013 mbar) within the following limits:

B.1) for fluids in Group 1 with a DN greater than 25 and the product of PS x DN greater than 2,000 bar (Annex II, table 8).

B.2) for fluids in Group 2 with a PS greater than 10 bar, a DN greater than 200 and the product PS x DN is greater than 5,000 bar (Annex II, table 9).

1.4 Accessories Safety and pressure accessories intended for equipment referred to in paragraphs 1.1, 1.2 and 1.3 including where such equipment is incorporated into an assembly.

2. The following sets defined under section 2.6 and listed below comprising 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 Assemblies intended for generating steam or superheated water at temperatures above 110 ° C comprising at least one pressure equipment subject to the action of fired or otherwise heated to represent a risk of overheating.

2.2 Assemblies other than those referred to in paragraph 2.1, if the manufacturer intends them to market and putting into service as assemblies.

2.3 Notwithstanding paragraph 2 assemblies intended for the production of hot water with a temperature exceeding 110 ° C which are manually fed with solid fuels and have a PS × V greater than 50 bar × they liter, shall meet the essential safety requirements set out in paragraphs 2.10, 2.11 and 3.4 and paragraph 5, paragraphs 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 Sections 1.1, 1.2 and 1.3 and in paragraph 2 of this Article shall be designed and manufactured in accordance with good engineering practice to use a member of the European Union, to ensure the safety in use state. They annexed to the pressure equipment and / or assemblies instructions sufficient and appropriate use, and must bear marks identifying the manufacturer or his authorized representative in the European Union. Without prejudice to other harmonization legislation of the European Union that provides for placement, such pressure equipment and / or assemblies must not bear the marking 'CE' as defined in Article 17.

Article 5. Freedom of movement.

1. No person may prohibit, restrict or impede, because of the hazards due to pressure:
1.1
marketing or putting into service, under the conditions set by the manufacturer of pressure equipment or assemblies referred to complying with the provisions of the royal decree and bearing the 'CE' marking, indicating they have undergone conformity assessment pursuant to Article 14.
1.2
marketing or putting into service of pressure equipment or assemblies which comply with the provisions of Article 4.3.

2. No person may prohibit, restrict or impede because of the hazards due to pressure, marketing or putting into service of pressure equipment or assemblies the conformity of which has been assessed by an inspection body of users 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 harmonization of the laws of the Member States on the marketing of pressure equipment.

This pressure equipment or assemblies must meet the following:

I) There may bear the marking "CE".

Ii) they may be used only in establishments operated by the group that is part of the inspection body of users who have assessed their conformity. The group shall apply a common safety policy as regards the technical specifications for the design, manufacture, inspection, maintenance and use of such pressure equipment and assemblies.

3. To ensure safe and correct use of pressure equipment and assemblies use the information contained in paragraphs 3.3 and 3.4 of Annex I shall be provided at least in Castilian.
CHAPTER II


Obligations of economic agents

Article 6. Obligations of manufacturers.


1. When placing on the market or use for their own purposes pressure equipment or assemblies that Article 4 referred to in paragraphs 1 and 2, manufacturers shall ensure that they are designed and manufactured in accordance with the essential safety requirements set out in Annex I. When placing on the market or use for their own purposes pressure equipment or assemblies referred to in Article 4.3, manufacturers shall ensure that they have been designed and manufactured in accordance with good practices the technique to use in a member State of the European Union.

2. Regarding pressure equipment or assemblies that Article 4 referred to in paragraphs 1 and 2 manufacturers will establish the technical documentation referred to in Annex III and carry out or apply the procedure for assessment of Conformance collected Article 14. When it has been shown that pressure equipment or meets the requirements set by the procedure referred to in this paragraph, manufacturers 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 ten years after the introduction of pressure equipment or assemblies on the market.

4. Manufacturers shall ensure that series production to remain in conformity with the Royal Decree. changes in design or characteristics of the pressure equipment or assemblies and changes in the harmonized standards or other technical specifications under which conformity is declared shall be duly taken into consideration. Manufacturers carry out sample testing of pressure equipment or assemblies market, investigate and, if necessary, keep a register of complaints of pressure equipment and assemblies nonconforming and recoveries of such equipment, and be kept informed distributors of all such monitoring. These records shall be available to the competent authorities.

5. Manufacturers shall ensure that their pressure equipment or assembly carries a number of type, batch or serial number or other element allowing their identification, or, if the size or nature of the equipment or the set does not permit, the information required on the packaging or in a document accompanying the team.

6. Manufacturers shall indicate their name, registered trade name or trademark and address of contact in the pressure equipment or assembly or, where not possible, on the packaging or in a document accompanying the team or group. The address shall indicate a single place you can contact the manufacturer. Contact details appear at least in Castilian.

7. Manufacturers shall ensure that pressure equipment or assemblies referred to in Article 4, paragraphs 1 and 2, accompanied by instructions and information on safety in accordance with paragraphs 3.3 and 3.4 of Annex I, the least in Castilian. Such instructions and information on safety will be clear, understandable and intelligible.

Manufacturers shall ensure that pressure equipment or assemblies referred to in Article 4.3, accompanied by instructions and information on safety, according to that Article 4.3, at least in Castilian. Such instructions and information on safety will be clear, understandable and intelligible.

8. Manufacturers who consider or have reason to believe that pressure equipment or an assembly which have been introduced in the market are not in accordance with this Royal Decree shall immediately take the necessary corrective measures to be compliant, or may withdraw from the market or recall if applicable. In addition, when pressure equipment or assemblies present a risk, manufacturers shall immediately inform the Autonomous Communities in which they traded and provide details, particularly on non-compliance and corrective measures taken.


9. In response to a reasoned request of the Autonomous Communities or the Ministry of Industry, Energy and Tourism, provide it with all the information and documentation necessary to demonstrate the conformity of pressure equipment or set the royal decree, at least in Castilian. Information and documentation may be provided in paper or electronic format. At the request of the Autonomous Communities or the Ministry of Industry, Energy and Tourism, will cooperate in any action to avoid the risks posed pressure equipment or assemblies placed on the market.

Article 7. Representatives authorized.

1. Manufacturers may appoint, by written mandate, an authorized representative. The obligations under Article 6.1 and the obligation to prepare technical documentation referred to in Article 6.2 will not be part of the mandate of the authorized representative.

2. The authorized representative shall perform the tasks specified in the mandate received from the manufacturer. The mandate shall allow the authorized do at least the following tasks representative:

2.1 Keeping 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 ten years after the introduction of the pressure equipment 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 request, provide information and documentation necessary to demonstrate the conformity of pressure equipment or assembly.

2.3 Cooperate with the Autonomous Communities and the Ministry of Industry, Energy and Tourism, at their request, on any action taken to eliminate the risks of the pressure equipment or the whole object of his mandate.

Article 8. Obligations of importers.

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

2. Before placing on the market of pressure equipment or assemblies that Article 4 referred to in paragraphs 1 and 2, importers shall ensure that the manufacturer has carried out the appropriate conformity assessment procedure in accordance with Article 14 shall ensure that the manufacturer has drawn up the technical documentation, that the pressure equipment or assemblies bearing the CE marking, they are accompanied by instructions and information on safety 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, paragraphs 5 and 6

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

Where an importer considers or has reason to believe that pressure equipment or set do not meet the essential safety requirements set out in Annex I, not sell such equipment or set up to comply. In addition, when the pressure equipment or assembly pose a risk, the importer shall inform the manufacturer and the Autonomous Communities in this regard.

3. Importers indicate their name, registered trade name or trademark and address of contact in the pressure equipment or assembly or, where not possible, on the packaging or in a document accompanying the team or group. Contact details appear at least in Castilian.

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

Importers shall ensure that the pressure equipment or assemblies referred to in Article 4.3 accompanied by instructions and information on safety at least in Castilian.

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

6. When a risk is identified for the protection of the health and safety of consumers, importers carry out sample testing of pressure equipment or assemblies market, investigate and, if necessary, keep a register of complaints equipment pressure or nonconforming sets and recoveries of such equipment, and keep distributors informed of any such monitoring of this type.

7. Importers who consider or have reason to believe that pressure equipment or an assembly which have been introduced in the market is not in conformity with the royal decree, immediately take the corrective measures necessary to bring it into line, or can withdraw it or recover, if applicable. In addition, when pressure equipment or assemblies present a risk, importers shall immediately inform the Autonomous Communities in which they traded and provide details, particularly on non-compliance and corrective measures taken.

8. During the ten years following the introduction of the pressure equipment or assembly in the market, keep a copy of the EU declaration of conformity at the disposal of the Autonomous Communities and the Ministry of Industry, Energy and Tourism, and ensure that, upon request, receive a copy of the technical documentation.

9. In response to a reasoned request of the Autonomous Communities or the Ministry of Industry, Energy and Tourism, importers shall provide the information and documentation necessary to demonstrate the conformity of the pressure equipment or assembly, at least in Castilian. Information and documentation may be provided in paper or electronic format. At the request of the Autonomous Communities or the Ministry of Industry, Energy and Tourism, will cooperate in any action to avoid the risks posed pressure equipment or assemblies that have entered the market.

Article 9. Obligations of distributors.

1. When making pressure equipment or assemblies, distributors shall act with due diligence regarding compliance with the requirements of this royal decree.

2. Before making any of the pressure equipment or assemblies referred to in Article 4, paragraphs 1 and 2, distributors shall ensure that bearing the CE marking and accompanied by the required documents, instructions and information security in accordance with paragraphs 3.3 and 3.4 of Annex I, written in at least Castilian, and that the manufacturer and the importer have complied with the requirements set out in Article 6, paragraphs 5 and 6 and Article 8.3, respectively .

When a distributor considers or has reason to believe that pressure equipment or set does not meet the essential safety requirements set out in Annex I, not sell such equipment or set until it is satisfied. In addition, when the pressure equipment or this all a risk, the distributor shall inform the manufacturer, the importer and the autonomous communities in which it marketed and the notifying authority.

Before placing pressure equipment or set listed in Article 4.3, distributors shall ensure that they are accompanied by appropriate use instructions written at least in Castilian, and that the manufacturer and the importer have complied with the requirements set out in Article 6, paragraphs 5 and 6 and Article 8.3, respectively.

3. Dealers pressure equipment or assemblies referred to in Article 4, paragraphs 1 and 2 shall ensure that the 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 pressure equipment or an assembly which they made is not in conformity with the royal decree, shall ensure that the necessary corrective measures are taken to bring it into line, or can withdraw it or recall if applicable. In addition, when pressure equipment or assemblies present a risk, distributors shall immediately inform the Autonomous Communities in which they traded and provide details, particularly on non-compliance and corrective measures taken.


5. In response to a reasoned request of the Autonomous Communities or the Ministry of Industry, Energy and Tourism, distributors shall provide the information and documentation necessary to demonstrate the conformity of pressure equipment or assemblies. Information and documentation may be provided in paper or electronic format. At the request of the Autonomous Communities or the Ministry of Industry, Energy and Tourism, will cooperate in any action to avoid the risks posed pressure equipment or assemblies that have entered the market.

Article 10 Cases in which obligations of manufacturers apply to importers and distributors apply.

For the purposes of this Royal Decree, be considered a manufacturer and therefore be subject to the obligations of the manufacturer under Article 6, an importer or distributor who pressure equipment or assemblies on the market under his name or make or modify pressure equipment already placed on the market, so that may be affected accordance with the requirements of this royal decree.

Article 11 Identification of economic agents.

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

A) any economic operator who has supplied them with pressure equipment or set.

B) any economic operator to whom they have supplied a pressure equipment or an assembly.

2. Economic operators shall be able to provide that information for at least ten years after they have been supplied with the pressure equipment or assembly and for ten years after they have supplied the pressure equipment or assembly.
CHAPTER III


Conformity and classification of pressure equipment and assemblies

Article 12 Presumption of conformity.

1. It is presumed that pressure equipment or assemblies referred to in Article 4, paragraphs 1 and 2, which are in conformity with standards or parts of harmonized standards whose references have been published in the "Official Journal of the European Union" , meet the essential safety requirements of these standards or parts thereof, listed in Annex I.

2. When the materials used in the manufacture of pressure equipment or assemblies are in accordance with European approvals for materials, the references have been published in the "Official Journal of the European Union" in accordance with Article 15.4, shall be presumed to comply with the essential safety requirements set out in Annex I.

Article 13. Classification of pressure equipment.

1. Pressure equipment in Article 4.1 shall be classified by category in accordance with Annex II, according to an increasing scale of degree of danger.

Purposes of such classification fluids shall be divided into the following two groups:

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

A) Unstable explosives and Divisions 1.1, 1.2, 1.3, 1.4 and 1.5.

B) Flammable gases of category 1 and 2.

C) Oxidizing gases Category 1

D) Flammable liquids of category 1 and 2.

E) Flammable liquids Category 3 where the maximum allowable temperature is above flashpoint.

F) Flammable solids of category 1 and 2.

G) substances and mixtures autoreactive types A to F.

H) pyrophoric liquids Category 1

I) pyrophoric solids Category 1

J) substances and mixtures in contact with water, emit flammable gases of categories 1, 2 and 3.

K) Oxidizing liquids categories 1, 2 and 3.

L) Oxidizing solids Category 1, 2 and 3.

M) organic peroxides types A to F.

N) Acute oral toxicity category 1 and 2.

O) Acute dermal toxicity category 1 and 2.

P) Acute inhalation toxicity Category 1, 2 and 3.

Q) Specific target organ toxicity (single exposure) Category 1


Group 1 also includes substances and mixtures contained in pressure equipment with a maximum allowable temperature TS exceeding the flashpoint of the fluid.

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

2. When a vessel is composed of several chambers, it is classified in the highest category of each individual camera. Where a chamber contains several fluids, classification shall be based on the fluid which requires the highest risk category.

Article 14. Conformity Assessment.

1. The procedures for conformity assessment to be applied to pressure equipment is determined by the category, as defined in Article 13 that the equipment is classified.

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

A) Category I:
Module A.


B) Category II:

Module A2.

Module D1.

Module E1.

C) Category III:

Modules B (design type) + D

Modules B (design type) + F.

Modules B (production type) + E.

Modules B (production type) + C2.
Module H.


D) Category IV:

Modules B (production type) + D

Modules B (production type) + F.
Module G.


Module H1.

Procedures conformity assessment is set out in Annex III.

3. Pressure equipment must be subjected to one of the procedures of conformity assessment, at the manufacturer, corresponding to the category to which it is classified. The manufacturer may also be applied, if desired, one of the set procedures for the higher category, if it exists.

4. Under the procedure of quality assurance of pressure equipment classified in categories III and IV, referred to in Article 4, paragraph 1.1, paragraph a), Article 4, Section 1.1, paragraph b), and Article 4, paragraph 1.2, the agency notified control when making unannounced visits, take a sample of equipment at the site of manufacturing or storage in order to perform, or send make the final assessment referred to in paragraph 3.2 of Annex I. to this end, the manufacturer shall inform the notified body control intended schedule of production. The agency notified Control made at least two visits during the first year of production and determine the frequency of subsequent visits accordance with the criteria set out in paragraph 4.4 of the modules D, E and H and paragraph 5, paragraph 4, H1 module.

5. In the case of the production of a single copy of vessels and pressure equipment classified in category III, referred to in Article 4, Section 1.1, paragraph b), under the procedure module H, the control body notified perform or have performed the final assessment, referred to in paragraph 3.2 of Annex I, each unit is made. To this end, the manufacturer shall communicate the intended schedule of production to the notified body control.

6. Assemblies referred to in Article 4.2 refers is subject to a general procedure of conformity assessment will include the following assessments:

A) The evaluation of each of the pressure equipment forming part of the assembly and are referred to in Article 4.1, if they are not previously undergone an evaluation procedure of conformity and marking "CE" by separate; the assessment procedure shall be determined by the category of each of the teams.

B) The assessment of the integration of the various elements of the set in accordance with paragraphs 2.3, 2.8 and 2.9 of Annex I, to be determined by the highest category of the equipment in question, regardless as applicable to safety accessories.

C) Evaluation of protection of an assembly against exceeding the permissible service limits in accordance with paragraphs 2.10 and 3.2.3 of Annex I shall be conducted according to the highest category of equipment to be protected.

7. Notwithstanding paragraphs 1 to 6 of this Article, the Autonomous Communities may, where justified, marketing and commissioning in the national territory of equipment to individual and assemblies referred to in Article 2 for they have not applied the procedures set out in paragraphs 1 to 6 of this article and whose use has interest for experimentation.


8. The documents and correspondence relating to the procedures for conformity assessment shall be drawn up at least in Castilian.

Article 15 European approval of materials.

1. Control notified the agency may issue the European approval for materials, at the request of one or more manufacturers of materials or equipment. Purpose, define and carry out, or cause to be made, the appropriate examinations and tests to certify the conformity of the types of material with the corresponding requirements of this Royal Decree. In the event recognized as being safe to use before 29 November 1999, existing data materials be taken into account when certifying such conformity.

2. Before issuing European approval for materials, the notified body monitoring shall forward the relevant information to the Member States and the European Commission. The comments submitted by the Member States or the European Commission, within three months, must be taken into account for issuing European approval of materials.

3. Control notified the agency shall send a copy of the European approval of pressure equipment materials to Member States, the other notified bodies and the European Commission. The list of European approvals for materials will be published and updated in the "Official Journal of the European Union".

4. When the European approval of materials meets the requirements set out in Annex I, the references of such approval, as well as an updated list of these approvals list shall be published in the "Official Journal of the European Union" may decide the European Commission 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 body checks may withdraw the approval provided check that should not have been issued or that the type of material is covered by a harmonized standard. It shall inform the Member States immediately to the other notified bodies and the Commission of any withdrawal of approval.

Article 16 EU Declaration of conformity.

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

2. The EU declaration of conformity is made according to the model shown in Annex IV, contain the elements specified in the relevant modules set out in Annex III and shall be updated. This statement will come at least in Castilian, for those pressure equipment or assemblies are introduced or marketed in Spain.

3. When 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 contain the identification of European standards and acts corresponding draw and publication references.

Article 17 CE.

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 established relating to the marketing of products and Regulation (EEC) No 339/93 is repealed.

2. The CE marking must be affixed in a visible, clearly legible and indelible:

A) In each of pressure equipment referred to in Article 4.1, or on your plate.

B) In each set mentioned in Article 4.2, full or in a state permitting final assessment as described in section 3.2 of Annex I.

3. When affixing the CE marking is not possible or not warranted due to the nature of the equipment or assembly, it will be placed on the packaging and to the accompanying documents. The team or set forth in paragraphs a) and b) of paragraph 2 of this Article shall be complete or in a state permitting final assessment as described in paragraph 3.2 of Annex I.

4. No need to place the CE marking on each individual pressure equipment consisting of a set of those in Article 4.2, as the marking retain individual teams to be incorporated into the set pressure.

5. The CE marking shall be affixed before the pressure equipment or assembly are introduced into the market.


6. The CE marking shall be followed by the identification number of the notified body control when this part of the control phase of production. The identification number of the notified body control will be affixed by the body itself or, under its instructions, by the manufacturer or his authorized representative.

7. The CE marking and, where applicable, 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 ensure the correct application of the regime governing the CE marking and take appropriate measures in case of misuse thereof, may apply the safeguard procedure of Article 32, before the breach of those measures.
CHAPTER IV


Notification of watchdogs and independent entities

Article 18. Bodies and independent entities subject to notification.

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

2. Independent entities which comply with Royal Decree 2200/1995, of December 28, and Article 21 of the Royal Decree, shall be notified to the European Commission and the other Member States to carry out those tasks under sections 3.1.2 and 3.1.3 of Annex I.

Article 19. Notifying Authority.

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

Article 20 Information obligation of notifying authority.

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

Article 21. Requirements for notified bodies control and independent entities.

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

A) The inspection body shall have legal personality.

B) The inspection body shall be independent of the organization or the pressure equipment or set it assesses. It may be a body belonging to a business association or professional federation representing undertakings involved in the design, manufacture, supply, installation, use or maintenance of pressure equipment or assemblies which evaluates, provided that its independence and the absence of conflicts of interest is demonstrated.

C) The inspection body, its top level management and the personnel responsible for carrying out the tasks of conformity assessment will not be the designer, manufacturer, supplier, installer, purchaser, owner, user or maintainer of pressure equipment or assemblies which assess, nor the authorized representative of any of them. This shall not preclude such use pressure equipment or assemblies assessed necessary for the activities of conformity assessment.

D) The inspection body, its top level management and the personnel responsible for carrying out their conformity assessment not intervene directly in the design, manufacture or construction, marketing, installation, use or maintenance of this pressure equipment or assemblies, nor represent the parties engaged in these activities. They shall not engage in any activity that may conflict with their independence of judgment or integrity in relation to the activities of conformity assessment for which they are notified. This applies in particular to consultancy services.

E) The control bodies shall ensure that activities of its subsidiaries or subcontractors do not affect the confidentiality, objectivity and impartiality of its activities in conformity assessment.


F) Control bodies and their personnel shall carry out the activities of conformity assessment with the highest level of professional integrity and the requisite technical competence in the specific field and shall be free from any pressure or incentive, especially financial, which might influence their judgment or the result of their activities in conformity assessment, particularly as regards persons or groups of persons with an interest in the results of these activities.

G) The inspection body will be able to perform all tasks of conformity assessment that may be assigned in accordance with the provisions of this Royal Decree and for which it has been notified, whether they perform the tasks the organism itself or on its behalf and under its responsibility. At all times and for each assessment procedure for conformity and for each type or category of pressure equipment for which it has been notified, the assessment body under the control agency have:

1st) personnel with technical knowledge and sufficient and appropriate to perform the tasks of conformity assessment experience.

2nd) descriptions of the procedures under which the conformity assessment is carried out ensuring the transparency and ability of reproduction of these procedures, and appropriate strategies and procedures that distinguish between tasks made as a watchdog and any other activity.

3rd) procedures to perform their due regard to the size of companies, the sector in which it operates, its structure, the degree of complexity of the product technology in question activities and if the process serial production.

H) The inspection body shall have the means necessary to perform the technical and administrative tasks connected with the activities of conformity assessment and have access to all necessary equipment or facilities you need.

Staff performing tasks conformity assessment will:

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

2nd) A satisfactory knowledge of the requirements of the assessments they carry out and authority necessary to perform them.

3rd) An appropriate knowledge and understanding of the essential safety requirements set out in Annex I, of the applicable harmonized standards and of the relevant provisions of the legislation harmonizing the European Union and the national legislation.

4th) The necessary capacity to draw up certificates, records and reports demonstrating that assessments have been made.

I) ensure the impartiality of the body, its top level management and responsible for the tasks of conformity assessment staff.

The remuneration of the top level management and responsible for the tasks of conformity assessment of a watchdog agency must not depend on the number of assessments carried out or on the results of these evaluations.

J) The inspection body sign a liability insurance, guarantee or other equivalent security to cover liability.

K) The staff of the inspection body shall observe professional secrecy with regard to all information collected as part of their duties, except with respect to the competent authorities and shall protect property rights.

L) The inspection body participate in relevant standardization activities and the activities of the coordination group of the notified body established under the laws of harmonization of the European Union applicable, or ensure that their personnel responsible for tasks of conformity assessment is informed about it, and apply as general guidance the administrative decisions and documents resulting from the work of the group.

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

Article 22 Subsidiaries and subcontracting.


1. The notified body control and independent entities may subcontract within the scope of this royal decree specific tasks related to conformity assessment or resort to a subsidiary and ensure that the subcontractor or the subsidiary meets the requirements of Article 21. || |
2. Notified bodies control and independent entities s, assume full responsibility for the tasks performed by subcontractors or subsidiaries wherever these are established.

3. Activities may be subcontracted or carried out by a subsidiary consent.

4. Agencies reported control and independent entities, keep at the disposal of the Autonomous Communities and the Ministry of Industry, Energy and Tourism documents supporting the qualifications of the subcontractor or the subsidiary and 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. Control agencies and independent entities submit an application for notification to the competent body of the Autonomous Community which is enabled as established in Royal Decree 2200/1995 of 28 December.

2. a description of its activities, the module or modules of conformity assessment and pressure equipment for which to be competent, as well as copy of the accreditation certificate issued by the National Agency: In this application the following documents shall be accompanied Accreditation (ENAC) and the supporting documentation have insurance, guarantee or equivalent financial guarantee covering their liability, as established by Royal Decree 2200/1995 of 28 December. The Autonomous Community shall, to register the control body in the Integrated Industrial Registry.

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

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 using the electronic notification and report any subsequent relevant changes to the notification.

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

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

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

Article 25. Changes to the notification.

1. If it is found that a body notified control or an independent entity no longer meets the requirements set out in Article 21 or is not fulfilling its obligations, the Ministry of Industry, Energy and Tourism may restrict, suspend or withdraw the notification as case, depending on the seriousness of the breach of the conditions or obligations, and shall inform the European Commission and the other Member States.

2. In case of withdrawal, restriction or suspension of notification or where the notified body or independent entity have ceased activity, the competent body of the Autonomous Community in which they operate take appropriate measures to ensure that the files of that body as appropriate or made available to the autonomous communities at their request or entity are treated by another notified body or other independent entity.


3. The Ministry of Industry, Energy and Tourism will provide the European Commission, at its request, the necessary information regarding the competition, compliance with the requirements and attributed responsibilities to the agency notified control or independent entity, for checking and, if necessary, implementing corrective measures.

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

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

1. Control notified bodies, conformity assessments carried out in accordance with the provisions of Article 14 and Article 15, and independent entities related tasks in sections 3.1.2 and 3.1.3 of Annex I.

2. They shall perform their activities taking due account of the size of companies, the sector in which it operates, its structure, the degree of complexity of the technology of the pressure equipment or assembly in question and the production process is in series.

However, in so doing will respect the degree of rigor and level of protection required for the pressure equipment meets 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 corresponding harmonized standards or other technical specifications, it will require the manufacturer to take appropriate corrective measures and not the certificate of conformity is issued.

4. If during the monitoring of conformity following the issue of the certificate, it is found that the pressure equipment is no longer complies, it shall notify the manufacturer defects or anomalies detected and urge this to take appropriate corrective measures indicating the deadlines that they be corrected and, if necessary, suspend or revoke the certificate, giving notice of the competent body for industry of the Autonomous Community in whose territory it does business.

5. If corrective measures are not taken or do not have the required effect, it will restrict, suspend or withdraw any certificates, as appropriate, giving notice of the competent body for industry of the Autonomous Community in whose territory it does business.

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

When a notified body control or an independent entity to issue a protocol, record, report or certification negative result of compliance with regulatory requirements, the applicant may claim disagreeing with it before the body itself or the entity and , if not reach an agreement before the competent body of the Autonomous Community in which filed for the purposes of the provisions of Article 16.2 of Law 21/1992 of 16 July, of Industry.

Article 28 Information obligation of notified bodies control and independent entities.

1. Notified bodies control and independent entities shall inform the body responsible for industrial safety of the Autonomous Community:

A) any refusal, restriction, suspension or withdrawal of certificates.

B) any circumstances affecting the scope or conditions of the notification.

C) any request for information on the activities of conformity assessment they have received from the point of view of market surveillance.

2. Upon request of the competent body for industrial safety of the Autonomous Community, inform the activities of conformity assessment performed within the scope of their notification and any other activity performed, including cross-border activities and subcontracting.

3. They provide the other bodies notified control and independent entities relevant information on issues relating to negative and, on request, the information related to positive results of conformity assessment.

Article 29 Coordination of notified bodies control and independent entities.


Notified bodies control and independent entities will participate in relevant standardization activities and the activities of the group or groups of coordination and cooperation between bodies notified directly or through designated representatives, they shall ensure that their assessment personnel are informed about it, and they shall apply as general guidance the administrative decisions and 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 joint pressure.

Article 15.3 of this Royal Decree and Articles 16 to 29 of Regulation (EC) No 765/2008 will of the European Parliament and of the Council of 9 July 2008, shall apply to the pressure equipment and assemblies referred to in Article 1 to the royal decree.

In accordance with the provisions of Law 21/1992 of 16 July, of Industry, without prejudice to the inspection and control measures that competent Autonomous Communities in the field develop within their territory, the Ministry of Industry , Energy and Tourism will promote plans and national campaigns by sampling check safety conditions of the equipment and assemblies that Article 1 of this royal decree concerns.

Article 31. Pressure equipment or assemblies which present a risk.

1. When enough are grounds to believe that pressure equipment or an assembly poses a risk to the health or safety of persons or domestic animals or property, should not have been done, it will be done an assessment the pressure equipment or assembly in question, taking into account all relevant requirements established in this royal decree. To this end, the relevant economic operators shall cooperate as necessary with the Autonomous Communities and the Ministry of Industry, Energy and Tourism.

When, in the course of that evaluation, it is noted that the pressure equipment or assembly does not fulfill the requirements established in this royal decree, the Autonomous Communities shall without delay require the relevant economic operator to take all corrective measures appropriate to adapt the pressure equipment or the assembly to those conditions, to withdraw it or recall it within a reasonable time, proportionate to the nature of the risk, as prescribed.

Will be informed monitoring relevant notified body 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. When you consider that non-compliance is not 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 evaluation and the measures that have required the economic operator to take.

3. The economic operator shall ensure that appropriate corrective measures in relation to all pressure equipment and assemblies which have affected the market throughout the European Union are adopted.

4. If the operator does not take adequate corrective actions, the Autonomous Communities adopt appropriate measures to prohibit or restrict the marketing of equipment or assemblies in the national market, to withdraw from that market, or retrieve provisional measures.

The Autonomous Communities concerned shall inform the Ministry of Industry, Energy and Tourism the provisional measures adopted, and shall inform the European Commission and the other Member States of such measures in case of disagreement with them may present objections to the .

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

In particular, it indicates whether non-compliance is due to one of the following reasons:

A) The team or group does not meet the requirements related to the health or safety of persons, protection of domestic animals or property.


B) shortcomings in the harmonized standards referred to in Article 12 conferring a presumption of conformity.

6. If within three months from the receipt of the information referred to in paragraph 4, no Member State or the Commission have any objections to an interim measure, the measure shall be deemed justified.

Safeguard procedure Article 32 of the European Union.

1. If once adopted corrective referred to in Article 31.3 and 4 measures, objections are raised against them, or if the Commission considers that such measures are contrary to the law of the European Union, the procedure laid safeguarding of the European Union.

2. If as a result of the application of the safeguard procedure, the European Commission considers the justified national measures, the Ministry of Industry, Energy and Tourism and the Autonomous Communities shall enforce such measures and for the team or group as not removed market, and it will inform the European Commission accordingly. If the national measure is considered justified, such a measure be withdrawn.

3. When the national measure is considered justified and the non-conformity of the equipment or assembly is attributed to a shortcoming in harmonized standards to which it refers to Article 31.5.b) of this Royal Decree, the procedure laid down in Article 11 Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardization, by Directives 89/686 / EEC and 93/15 / EEC amending and Directive 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 amending Decision 87/95 / EEC and Decision No 1673/2006 / EC of the European Parliament and of the Council repealing.

Article 33. conformity Pressure equipment or assemblies which present a risk.

1. If it is found having performed an evaluation under Article 31.1 that pressure equipment or set, but as under the present royal decree, presents a risk to the health or safety of persons, for pets or property , the relevant economic operator to take all appropriate measures to ensure that the team or group in question does not present such a risk when placed on the market or to withdraw it or recall it within such reasonable period will be required, proportional the nature of the risk to be determined.

2. The economic operator shall ensure that corrective action is taken in relation to all teams or groups that have affected the market throughout the European Union are adopted.

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

Article 34 Formal non-compliance.

1. Without prejudice to Article 31, if it is found one of the situations listed below, the relevant economic operator to remedy the lack of conformity in question you will be asked:

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

B) it has been placed the identification number of the notified body involved in the control phase of production in violation of Article 17 or is not set.

C) they have not placed marks and labeling referred to in paragraph 3.3 of Annex I or have been affixed in violation of Article 17 or paragraph 3.3 of Annex I.

D) Absence of the EU declaration of conformity or has not been properly established the EU declaration of conformity.

E) technical documentation is not available or is incomplete.

F) The information referred to in Article 6.6 or Article 8.3 is missing, false or incomplete.

G) any other administrative requirement in Article 6 or Article 8 is not met

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

CHAPTER VI



Penalties
Article 35. Penalty system.

To breaches of the provisions of the Royal Decree will be of application the regime of infractions and sanctions established in Title V of Law 21/1992 of 16 July, of Industry.

First additional provision. Commissioning.

For the commissioning of pressure equipment and assemblies real present the procedures laid down in Royal Decree 2060/2008, of 12 December, Regulation decree approved equipment must be followed pressure and technical instructions.

Second additional provision. References Royal Decree 769/1999 of 7 May.

The references in the laws, regulations and administrative provisions in force, the Royal Decree 769/1999 of 7 May laying down rules for the application of the Directive of the European Parliament and the Council are held, 97 / 23 / EC on pressure equipment and amending Royal Decree 1244/1979 of 4 April, which approved the Regulation of pressure vessels, shall be construed as references to this royal decree.

First transitional provision. transient for marketing and commissioning of pressure equipment and assemblies which comply with the provisions of Royal Decree 769/1999, of 7 May period.

1. Pressure equipment and assemblies which comply with the provisions of Royal Decree 769/1999 of 7 May laying down rules for the application of the Directive of the European Parliament and of the Council 97/23 / EC are issued, on pressure equipment and amending Royal Decree 1244/1979, of 4 April, which approved the Regulation of pressure vessels may continue to be marketed until 19 July 2016, except for Article 9 of Royal Decree 769/1999, of May 7, in which case it shall comply with the provisions of Article 13 of royal Decree from the date of entry into force. The commissioning of such equipment and assemblies may once surpassed that date made.

2. Certificates and decisions issued by control bodies under the Royal Decree 769/1999, of May 7 shall be valid under this royal decree with.

Second transitional provision. Regulations applicable to pressure equipment or assemblies placed in service prior to the entry into force of this Royal Decree.

Pressure equipment and assemblies the commissioning had been effected prior to the entry into force of this royal decree, continue to be governed by the technical requirements that they have come to apply until that date.

Single derogatory provision. Repeal legislation.

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

2. In general, also, they are repealed all provisions of equal or lower rank opposing the provisions of this royal decree.

First final provision. competential title.

This royal decree is issued under the provisions of Article 149.1.13 of the Constitution, which grants the State exclusive competence on bases and coordination of general planning of economic activity.

Second final provision. Incorporation of European Union law.

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

Final disposition third. policy development.

The Minister of Industry, Energy and Tourism is authorized to issue the implementing rules of this royal decree.

Fourth final provision. Enabling updating the technical content of the annexes of this royal decree.

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

Final provision fifth. Entry into force.


Article 13 of this royal decree shall enter into force on the day following its publication in the "Official Gazette" day and other items from 19 July 2016.

Given in Madrid, on 24 July 2015.
FELIPE R.


The Minister of Industry, Energy and Tourism


LOPEZ Jose Manuel Soria ANNEX I

Essential safety requirements


A. General requirements
0.Observaciones preliminary


1. The obligations under the essential safety requirements set out in this Annex for pressure equipment also apply to assemblies where the corresponding risk exists.

2. The essential safety requirements contained in the Directive are imperatives. The obligations arising from such essential safety requirements only apply when the pressure equipment in question involves the corresponding risk when used in the reasonably foreseeable conditions by the manufacturer.

3. The manufacturer is obliged to carry out an assessment of the risks and dangers to determine those which apply to his equipment on account of pressure; they must then design and manufacturing to taking into account the evaluation.

4. The essential safety requirements are interpreted and applied in a manner that takes into account the state of the art and practice at the time of design and manufacture as well as technical and economic considerations compatible with a high degree of protection health and safety.

1. General

1.1 Pressure equipment shall be designed, manufactured, tested and, where appropriate, equipped and installed so that the safety of funds be ensured if put into service in accordance with the manufacturer's instructions, or in reasonably foreseeable conditions.

1.2 To choose the most appropriate solutions, the manufacturer must apply the principles set out below and in the same order:

A) Eliminate or reduce risks as much as reasonably possible.

B) Implement protective measures against risks that can not be eliminated.

C) Report, where appropriate, users of residual hazards and indicate whether it is necessary to take appropriate measures to reduce the risks at the time of installation or use special measures.

1.3 Should known or can be clearly foreseen the possibility of misuse, the pressure equipment is designed to prevent danger from such misuse or, if that is not possible, properly indicate that the pressure equipment must not be used that way.

2. design

2.1 General.

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

The design will include appropriate safety factors to be based on general methods which record using appropriate safety margins consistent manner to prevent all kinds of faults have.

2.2 Design for adequate strength.

2.2.1 Pressure equipment must be designed to withstand the loads corresponding to its intended use and for other reasonably foreseeable operating conditions. In particular, the following factors will be taken into account:

A) The external pressure and internal pressure.

B) The ambient temperature and the operating temperature.

C) static pressure and mass content operating conditions and test.

D) The loads due to traffic, wind and earthquakes.

E) The forces and moments arising from the reaction media, mounting devices, pipes, and so on.

F) corrosion and erosion, fatigue, etc.

G) The decomposition of unstable fluids.

Various loadings which can occur at the same time be considered taking into account the probability of their simultaneous occurrence.
2.2.2
design for adequate strength will be based on any of the following considerations:

As a general rule, a calculation method as specified in paragraph 2.2.3 supplemented, if necessary by an experimental design method as specified in paragraph 2.2.4.

An experimental design method without calculation, as specified in paragraph 2.2.4 in the event that the product of the maximum allowable pressure PS and the volume V is less than 6,000 bar · L, or the product PS · DN less than 3,000 bar.

2.2.3 Calculation method.

A) Pressure containment and other charges.


The allowable stresses in pressure equipment is limited according to reasonably foreseeable failure modes under operating conditions. To this end, safety factors to eliminate fully any uncertainty arising out of manufacture, actual operational conditions, stresses, calculation models and the properties and behavior of the material will be applied.

These calculation methods provide sufficient safety margins consistent, where it appropriate, to the provisions of paragraph 7.

This shall be met by applying, as a complement to another method or in combination with it, if necessary, the most appropriate method listed below:

Design by formulas.

Design by analysis.

Design by fracture mechanics.

B) resistance.

Appropriate design calculations must be used to determine the resistance of the pressure equipment in question.

In particular:

The calculation pressures must not be less than the maximum allowable pressures and take into account static and dynamic pressure fluid and the decomposition of unstable fluids. If a vessel is separated into individual pressure containment chambers, the partition wall thickness is calculated based on the highest possible chamber pressure relative to the lowest pressure possible in the adjoining chamber.

The calculation temperatures must allow for appropriate safety margins.

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

The maximum stresses and maximum concentrations voltage values ​​will remain within safe limits.

For the calculation of the pressure containment appropriate values ​​of material properties based on proven data will be used, and taking into account the provisions of paragraph 4 and the appropriate safety factors.

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

The yield, 0.2% or 1.0% proof stress, as appropriate, to the temperature calculation.

The tensile strength.

Resistance versus time, ie, the creep resistance.

The fatigue data.

Young's modulus (modulus of elasticity).

The proper amount of plastic deformation.

The flexural fracture energy.

The breaking strength.

Shall apply to the characteristics of the coefficients of resistance of materials suitable together depending, for example, the nature of non-destructive testing, the properties of materials joined and the operating conditions envisaged.

The design shall take due account of all reasonably foreseeable degradation mechanisms (eg corrosion, creep, fatigue) corresponding to its intended use equipment; the instructions in paragraph 3.4 refers to draw attention to design features which are relevant to the life of the equipment, such as:

For creep: design hours of operation at specified temperatures.

For fatigue: design number of cycles at specified stress levels.

For corrosion: design corrosion allowance.

C) Stability.

If the calculated thickness does not allow for adequate structural stability, the necessary measures will be taken to correct, taking into account the risks from transport and handling.

2.2.4 experimental design method.

The design of the equipment may be validated wholly or partly by a testing program to be conducted with a representative sample of the equipment or the category of equipment.

The test program must be clearly defined prior to testing and accepted by the notified body, if any, responsible for the module conformity assessment design.

The program will define test conditions and criteria for acceptance or refusal. The exact values ​​of the essential dimensions and characteristics of the constituent materials of the equipment tested shall be determined before the test.

Where appropriate, during tests, the critical zones of the pressure equipment must be identifiable with adequate instrumentation capable of registering strains and stresses with sufficient precision.

The test program will include:


A) A resistance test pressure to check that, at a pressure with a defined safety margin relative to the maximum allowable pressure, the equipment does not exhibit significant leaks or above a certain limit deformation; the test pressure shall be determined taking into account the differences between the values ​​of the geometric characteristics and material measured in the test conditions and the values ​​used for design purposes; also it takes into account the difference between the test temperatures and design.

B) where the risk of creep or fatigue exists, appropriate tests determined on the basis of the service conditions laid down for the equipment, for example the length of service at specified temperatures or the number of cycles at specified stress levels.

C) Where necessary, additional tests concerning other factors referred to in paragraph 2.2.1 such as corrosion or external actions.

2.3 Provisions to ensure the use and operation safely.

The mode of operation of the pressure equipment will be designed for handling preclude any reasonably foreseeable risk. Special attention will be given to you:

At closures and openings.

A dangerous discharge of safety valves.

A devices to prevent physical access whilst pressure or vacuum.

A temperature of the surface, given the intended use.

A decomposition of unstable fluids.

In particular, pressure equipment fitted with an access door must be fitted with an automatic or manual device enabling the user easily to ascertain that the opening will not present any risk. Furthermore, where the opening can be operated quickly, the pressure equipment will be equipped with a device to prevent opening when the pressure or temperature of the fluid presents a hazard.
Means of examination 2.4
:

A) Pressure equipment must be designed so that all necessary safety tests to be made.

B) means shall be provided for determining the internal condition of the pressure equipment where necessary to ensure the continued safety of the equipment, such as openings allowing physical access to the inside of the computer to perform the appropriate examinations safely and ergonomic.

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

When the computer is too small for physical internal access.

When opening the pressure equipment would adversely affect the inside.

When it has been proven that the substance containing the pressure equipment does not deteriorate the material from which it is made, and that is not reasonably foreseeable no other internal degradation mechanisms.
2.5
purge systems and ventilation.

Be available adequate systems purge and vent pressure equipment when necessary for:

Avoid harmful, such as water hammer, the collapse caused by the vacuum, corrosion and uncontrolled chemical reactions effects; They will take into account all stages of operation and testing, particularly pressure testing.

Permit cleaning, inspection and maintenance in a safe.

2.6 Corrosion or other chemical actions.

Be available, if necessary, a tolerance or adequate protection against corrosion or other chemical attack, taking due account of the intended and reasonably foreseeable use.

Wear 2.7.

If they can be severe conditions of erosion or abrasion, appropriate measures will be taken:

Minimize that effect by appropriate design, for example, increasing the thickness of the material, or by using liners or cladding materials.

Allow replacement of the parties most affected

Draw attention, in the instructions referred to in paragraph 3.4, on the necessary measures for use in permanent security conditions.
2.8
sets.

Assemblies must be designed so that:

The elements to be assembled together are suitable and reliable for their service.

All components are properly integrated and assembled in an appropriate manner.

2.9 Provisions for filling and emptying.


Where appropriate, the pressure equipment must be designed and provided with accessories, or will be scheduled installation, to ensure that the filling and emptying the following are performed safely in terms, in particular, risks:

A) In filling:

The overfilling or overpressurization having regard in particular to the filling ratio and the vapor pressure at the reference temperature.

The instability of the pressure equipment.

B) discharge: the uncontrolled discharge of pressurized fluid.

C) on filling or discharge: connection and disconnection risks.

2.10 Protection against exceeding the allowable limits of pressure equipment.

Where, under reasonably foreseeable conditions, the allowable limits could be exceeded, the pressure equipment will be equipped with suitable protective devices, or designed to install them, unless protection is guaranteed by other devices integrated protection throughout.

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

Protective devices and combinations of these include:

A) safety accessories as defined in Article 2.4.

B) Where appropriate, adequate monitoring devices such as indicators or alarms which enable adequate manual or automatic intervention, to keep the pressure equipment within the allowable limits.

2.11 Safety accessories.

2.11.1 Safety accessories must:

Designed and constructed as to be reliable and are adapted to the conditions of service provided and taking into account, where appropriate, the requirements for maintenance and testing of the devices.

Being independent of other functions, unless these can not affect its safety function.
Reply
early appropriate design for a convenient and reliable protection; These principles include, in particular safety in case of failure, redundancy, diversity and self-control.
2.11.2
pressure limiting devices.

These devices shall be designed so that the pressure will not permanently exceed the maximum allowable pressure PS; however, a short-term increase of the pressure is allowed, where appropriate, in accordance with paragraph 7.3.
2.11.3 Devices
temperature control.

These devices have an adequate response time for security reasons and consistent with the measurement function.

2.12 External fire.

Where necessary, pressure equipment shall be designed and, where appropriate, fitted with suitable accessories, or will be prepared to incorporate these, in order to meet the requirements for damage limitation if external fire, having regard, in particular, the use for which they are intended.

3. manufacturing

3.1 Manufacturing procedures.

The manufacturer shall ensure proper implementation of the provisions set out in the design stage by applying the appropriate techniques and methods, especially with regard to the aspects listed below.
3.1.1 Preparation
components.

The preparation of components (eg forming and chamfering) will not cause defects, cracks or changes in the mechanical characteristics that could endanger the safety of pressure equipment at risk.
3.1.2
permanent Unions.

Permanent joints of materials and adjacent areas will be exempt from any surface or internal deficiencies detrimental to the safety of the equipment.

The properties of permanent joints must meet the minimum properties specified for the materials to be joined unless in design calculations are specifically taken into account other relevant property values.

For pressure equipment, permanent joining of components which contribute to the pressure resistance of equipment and components which are directly integrated will be carried out by qualified personnel using appropriate procedures.

The procedures and personnel must be approved for pressure equipment in categories II, III and IV, by a competent third party which may be, at the manufacturer:

Notified a body.

A third entity recognized by a Member State as provided for in Article 20.


To carry out these approvals the third quoted perform or have performed the examinations and tests specified in the appropriate harmonized standards or equivalent examinations and tests are conducted.

3.1.3 Non-destructive testing.

For pressure equipment, non-destructive testing of permanent joints will be performed by qualified personnel. For pressure equipment in categories III and IV, the personnel must be approved by a third entity recognized by a Member State pursuant to Article 20

Heat treatment 3.1.4.

Where there is a risk that the manufacturing process will change the material properties to the point of endangering the integrity of the pressure equipment, suitable heat treatment in the appropriate stage of manufacture will apply.

3.1.5 Traceability.

They establish and maintain appropriate procedures for identifying materials equipment items which contribute to pressure resistance by suitable means from receipt, through production, to final testing of manufactured pressure equipment .

3.2 final evaluation.

The pressure equipment shall be subject to final assessment as described below.

3.2.1 Final inspection.

The pressure equipment will undergo a final inspection to assess visually and by examination of the accompanying documents compliance with the requirements of this Royal Decree. the tests carried out during manufacture may be taken into account. In so far as necessary for security reasons, final inspection will take place inside and outside of all parts of the instrument, if any, during the manufacturing process (for example, when no longer possible consideration during final inspection).
3.2.2 Test
.

The final assessment of the pressure equipment will include an endurance test pressure normally consist of a hydrostatic pressure test at a pressure at least equal, where appropriate, to the value laid down in paragraph 7.4.

For equipment of category I series, this test may be performed on a statistical basis.

In cases where the hydrostatic pressure test is harmful or not feasible, other tests may be carried recognized value. Before carrying out tests other than the hydrostatic pressure test complementary measures such as non-destructive tests or other methods of equivalent efficacy apply.

3.2.3 Inspection of safety devices.

For assemblies, the final assessment must also include a check of the safety devices intended to check full compliance with the requirements set out in paragraph 2.10.

3.3 Marking and labeling.

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 is provided:

A) for all pressure equipment:

The year of manufacture.

The identification of the pressure equipment according to its nature, for example, the type, identification of the serial or batch identification and serial number.

The maximum or minimum allowable limits essential.

B) Depending on the type of pressure equipment, further information necessary for safe installation, operation or use and, where appropriate, also for maintenance and periodic inspection such as:

The volume V of the pressure equipment in liters (L).

The nominal pipe size (DN).

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

The set pressure of the safety device in bar.

The power of the pressure equipment in kW.

The supply voltage in volts (V).

Intended use.

The degree of filling, expressed in kg / L.

The maximum filling mass in kg.

The tare weight in kg.

The group fluids.

C) Where appropriate, the warnings fixed to the pressure equipment drawing attention to inappropriate uses that experience, are known to occur.

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

Where applicable, appropriate documentation may be used to avoid repetitive marking of individual parts such as piping components, intended for the same assembly.


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

They may be labels or any other suitable means to indicate the filling mass and warnings paragraph c) refers to used, provided it remains legible for the appropriate period of time.
Operating Instructions 3.4
:

A) When a team is marketed under pressure, accompanied, as far as relevant, with instructions for the user, containing all the information necessary for safety in regards to:

The mounting including assembling of different pressure equipment.

The commissioning.

Utilization.

The maintenance including checks by the user.

B) The instructions shall include the information specified in the pressure equipment pursuant to paragraph 3.3, except for the identification of the series, and shall be accompanied, where appropriate, technical documentation and drawings and diagrams necessary for correct understanding.

C) Where applicable, the instructions will also refer to the risks of improper use under paragraph 1.3 and particular features of the design in accordance with section 2.2.3 with.

4. materials

The materials used for the manufacture of pressure equipment will be suitable for this application during the scheduled lifetime unless replacement is foreseen.

Welding materials and other joining materials need fulfill only the relevant requirements of paragraph 4.1 of paragraph a) section 4.2 and section 4.3, first paragraph, both individually and in a joined.

4.1 Materials for pressurized parts:

A) Have adequate to all reasonably foreseeable operating conditions and characteristics and test conditions, in particular, they have sufficient ductility and toughness; where appropriate, the characteristics of these materials shall comply with the requirements of paragraph 7.5; in addition, it should be done in particular in selecting materials to prevent, if necessary, rupture embrittlement; where for specific reasons brittle material has to use appropriate measures are taken.

B) Have sufficient chemical resistance to the fluid contained in the pressure equipment; the chemical and physical properties necessary for safe operation can not be significantly affected within the expected useful life of the equipment.

C) not be significantly affected by aging.

D) be appropriate for the intended processing methods.

E) they are selected so that significant negative effects are avoided when different materials are put together.

4.2 The pressure equipment manufacturer:

A) will adequately define the values ​​necessary for the design calculations in paragraph 2.2.3 refers to, as well as the essential characteristics of the materials and their treatment in paragraph 4.1 concerns.

B) Include in the technical documentation the data for compliance with the provisions of this Royal Decree on materials from one of the following ways:

The use of materials in accordance with harmonized standards.

The use of materials covered by a European approval of pressure equipment materials in accordance with Article 15.

A particular evaluation of materials.

C) for pressure equipment in categories III and IV, shall ensure that the notified body responsible for the procedures of conformity assessment of pressure equipment carry out a specific assessment of the particular material appraisal.

4.3 The equipment manufacturer shall take appropriate measures to ensure that the material used conforms with the required specification. In particular, with respect to each material, documentation prepared by the manufacturer that compliance with a specification is certified will be obtained.

For the main parts subject to pressure equipment in categories II, III and IV, such documentation will consist of a certificate of specific product control.

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


B. Specific requirements for certain pressure equipment

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

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

This category of pressure equipment includes:

Steam generators and hot water to Article 4.1.2, such as hot water boilers and steam home, superheaters and reheaters, boilers heat recovery boilers refers waste incineration boilers, electric heating electrodes or immersion type and pressure cookers with accessories and, where appropriate, their water treatment systems supply and fueling.

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

This pressure equipment must be calculated, designed and constructed so as to avoid or minimize the risk of significant loss of containment from overheating. In particular it shall, as appropriate:

A) appropriate means of protection are established to restrict operating parameters such as input and heat dissipation and, where appropriate, the level of the fluid to avoid any risk of local and general overheating.

B) sampling points are provided where necessary to evaluate the fluid properties in order to avoid risks related to deposits or corrosion.

C) the necessary measures are taken to eliminate risks of damage from deposits.

D) have the means of safe removal of residual heat after the arrest.

E) steps are taken to prevent dangerous accumulation of ignitable mixtures of combustible substances and air, or flame blowback.

6. Pipelines defined in Article 4.1.3

The design and manufacture shall ensure that:

A) The risk of overstressing from inadmissible free movement or excessive forces, eg on flanges, connections, hoses bellows or tube, is adequately controlled by clamps, braces, fasteners, adjustments and pretensioners.

B) Where there is the possibility of condensation of gaseous fluids inside the tubes, are available the means to purge and expel deposits from low areas to avoid damage from water hammer or corrosion.

C) potential damage from turbulence and formation of vortices are duly taken into account; in this regard the relevant provisions of paragraph 2.7 shall apply.

D) the risk of fatigue due account is due to vibrations in pipes.

E) Where pipes containing fluids in Group 1, appropriate means are provided to isolate the intake ducts which represents a significant risk because of their size.

F) the risk of inadvertent discharge is minimized; jacks must be clearly marked on the permanent side, indicating the fluid contained.

G) The position and route of underground piping is at least recorded in the technical documentation to facilitate maintenance, inspection or repair safely.

7. specific quantitative requirements for certain pressure equipment

The following provisions apply as a general rule. However, when not applied, even if they are not specifically mentioned materials or harmonized standards are applied, the manufacturer must demonstrate that appropriate measures have been taken to achieve an equivalent overall level of safety.

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

7.1 Allowable stresses.
7.1.1
symbols. Re / t, yield limit, indicates the value at the calculation temperature:

The upper flow limit for a material presenting upper and lower flow limits.

The conventional yield of 1.0% for austenitic steel and unalloyed aluminum.

The conventional yield of 0.2% in other cases.


Rm / 20 indicates the minimum value of the maximum tensile strength at 20 ° C.

Rm / t designates the ultimate strength at the maximum design temperature traction.

7.1.2 The permissible general tension membrane for predominantly static loads and for temperatures outside the range in which creep is significant, will not exceed the lower of the following values, depending on the material that is try:

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

In the case of austenitic steel:

If the elongation after rupture exceeds 30%, 2/3 of R e / t.

Or alternatively, and if its elongation after rupture exceeds 35%, 5/6 of R e / R m 1/3 t / t.

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

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

For aluminum alloys, except the precipitation hardening, 2/3 of R e / R m of 05.12 t / 20.

7.2 Coefficients joints.

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

For equipment subject to destructive and non destructive tests required to check all the boards no significant defects: 1.

For equipment subject to random non-destructive testing: 0.85.

For equipment not subject to non-destructive testing visual inspection: 0.7.

When necessary be taken into account also the type of stress and the mechanical and technological properties of the joint.
7.3
pressure relief devices, especially for pressure vessels.

The momentary pressure surge referred to in paragraph 2.11.2 is maintained at 10% of the maximum allowable pressure.

Hydrostatic pressure test 7.4.

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

The load corresponding to the maximum pressure that can undergo the equipment in service, taking into account its maximum allowable pressure and its maximum allowable temperature, multiplied by the coefficient 1.25.

The maximum allowable pressure multiplied by the coefficient 1,43.

7.5 Characteristics of materials.

Unless other values ​​are required in accordance with different criteria to be taken into consideration, the steel will be considered with sufficient ductility, in accordance with paragraph 4.1.1, if its elongation after rupture in a trial with traction performed according to a standard procedure is at least equal to 14% and energy bend-breaking measure in a test tube ISO V is at least equal to 27 J, at a temperature not exceeding 20 ° C, but not exceeding with the lowest temperature of operation envisaged.
ANNEX II


Pictures of conformity assessment

1. The tables have been used the following references to categories of modules:

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

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

3. The pressure accessories defined in Article 2.5 and listed in Article 4.1.4, are classified according to:

Its maximum allowable pressure PS.

From volume V or their nominal size DN, as appropriate.

The group of fluids for which they are intended.

The appropriate table for vessels or piping is used to determine the category of conformity assessment.

When the volume and the nominal size specified in the second indent of the first paragraph is deemed appropriate, the pressure accessory is classified in the highest category.

4. The demarcation lines in the following tables of conformity assessment indicate the upper limit for each category.

Table 1 Vessels referred to in Article 4, Section 1.1, paragraph a.1)


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Exceptionally, vessels intended to contain an unstable gas and falling within categories I or II under Table 1, shall be classified in category III.

Table 2. Vessels referred to in Article 4, Section 1.1, paragraph a.2)

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Exceptionally, portable extinguishers and bottles for breathing apparatus are classified at least in category III.

Table 3. Vessels referred to in Article 4, Section 1.1, paragraph b.1)

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Table 4 Vessels referred to in Article 4, Section 1.1, paragraph b.2)

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Exceptionally, assemblies intended for the production of hot water referred to in the second paragraph of Article 4.2 will be subject either to an EU-type examination (Module B: type design) so check your conformity with the essential requirements set out in paragraphs 2.10, 2.11 and 3.4, and section 5, paragraphs a) and d) of Annex I or a system of full quality assurance (module H).

Table 5 Pressure equipment referred to in Article 4, Section 1.2

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As an exception, pressure cookers are subject to an assessment procedure pursuant equivalent to at least one of the category III modules.

Table 6 Piping referred to in Article 4, Section 1.3, paragraph a.1)

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As an exception, piping intended for unstable gases and belonging to categories I or II under Table 6, shall be classified in category III.

Table 7 Piping referred to in Article 4, Section 1.3, paragraph a.2)

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Exceptionally, all piping containing fluids at a temperature above 350 ° C, and belonging to Category II under Table 7 must be classified in category III.

Table 8 Piping referred to in Article 4, Section 1.3, paragraph b.1)

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Table 9 Piping referred to in Article 4, Section 1.3, paragraph b.2)

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ANNEX III


Procedures conformity assessment

The obligations arising from the provisions laid down in this Annex for pressure equipment also apply sets.
Module A


(Internal production control)

1. Concept.

Internal production control is the procedure of conformity assessment whereby the manufacturer fulfills the obligations laid down in paragraphs 2, 3 and 4, and ensures and declares on his sole responsibility that pressure equipment concerned satisfy the requirements of this royal decree.

2. Technical documentation.

The manufacturer shall establish the technical documentation.

The technical documentation possible to assess the pressure equipment meets the relevant requirements, and shall include an analysis and appropriate risk assessment. It will specify the applicable requirements and cover insofar as relevant for assessment, design, manufacture and operation of the pressure equipment. The technical documentation shall, wherever applicable, at least the following elements:

A general description of the pressure equipment.

The conceptual design and manufacturing drawings and diagrams of components, subassemblies, circuits, etc.

The descriptions and explanations necessary for the understanding of those drawings and diagrams and the operation of the pressure equipment.

A list of harmonized standards, applied in full or in part, whose references have been published in the "Official Journal of the European Union ', and when these have not been applied harmonized standards, the description of the solutions adopted to meet the essential safety requirements of this royal decree; if harmonized standards partly applied, they shall be specified in the technical documentation parts that have been applied.


The results of the design calculations made, examinations carried out, etc.

The test reports.

3. Manufacturing.

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

4. EC and EU declaration of conformity marking.

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 pressure equipment model and keep it with the technical documentation available to the national authorities for a period of ten years from the introduction of the pressure equipment in the market. The EU declaration of conformity shall identify pressure equipment for which it has been prepared.

A copy of the EU declaration of conformity to the competent authorities be provided upon request.

5. Authorized representative.

The manufacturer's obligations referred to in paragraph 4 may be fulfilled by his authorized representative, on his behalf and under his responsibility, provided that they are specified in the mandate.
Module A2


(Internal production control more control teams monitored

pressure at random intervals)

1. Concept.

The internal production control plus supervised pressure equipment checks at random intervals up the process of conformity assessment by the manufacturer fulfills the obligations laid down in paragraphs 2, 3, 4 and 5, and ensures and declares on his sole responsibility that the pressure equipment concerned satisfy the requirements of this royal decree.

2. Technical documentation.

The manufacturer shall establish the technical documentation. The documentation possible to assess the pressure equipment meets the relevant requirements and include an analysis and appropriate risk assessment. It will specify the applicable requirements and cover insofar as relevant for assessment, design, manufacture and operation of the pressure equipment. The technical documentation shall, wherever applicable, at least the following elements:

A general description of the pressure equipment.

The conceptual design and manufacturing drawings and diagrams of components, subassemblies, circuits, etc.

The descriptions and explanations necessary for the understanding of those drawings and diagrams and the operation of the pressure equipment.

A list of harmonized standards, applied in full or in part, whose references have been published in the "Official Journal of the European Union" and, where these have not been applied harmonized standards, the description of the solutions adopted to meet the essential safety requirements of this royal decree; if harmonized standards partly applied, they shall be specified in the technical documentation parts that have been applied.

The results of the design calculations made, examinations carried out, etc.

The test reports.

3. Manufacturing.

The manufacturer must take all necessary measures for the manufacturing process and its monitoring ensure conformity of the manufactured pressure equipment with the technical documentation referred to in paragraph 2 and with the requirements of this Royal Decree that apply.

4. Final evaluation and monitoring of pressure equipment.

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

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

During these unannounced visits, the notified body:

Will ensure that the manufacturer actually performs final assessment in accordance with paragraph 3.2 of Annex I.

It will take samples of pressure equipment at the premises of manufacturing or storage to carry out checks; The notified body assesses the number of samples to be taken equipment and the need to make or send make all or part of the final evaluation of the samples.


The acceptance sampling procedure to be applied is intended to determine whether the manufacturing process of the pressure equipment is performed within acceptable limits in order to ensure compliance team.

If one or more pressure equipment or assemblies not conform, the notified body must take appropriate measures.

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

5. EC and EU declaration of conformity marking.

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 pressure equipment model and keep it with the technical documentation available to the national authorities for a period of ten years after the introduction of the pressure equipment on the market . The EU declaration of conformity shall identify pressure equipment for which it has been prepared.

A copy of the EU declaration of conformity to the competent authorities be provided upon request.

6. Authorized representative.

The manufacturer's obligations contained in paragraph 5 may be fulfilled by his authorized representative, on his behalf and under his responsibility, provided that they are specified in the mandate.
Module B


( "EU-type" Examination)

I. EU production type examination

1. The EU test -type type of production is part of a process of conformity assessment by which a notified body examines the technical design of pressure equipment and verifies and attests that the technical design meets the requirements of this royal decree.

2. The EU test -type type of production must be in the form of an assessment of the adequacy of the technical design of the pressure equipment by examining the technical documentation and supporting evidence referred to in paragraph 3, and as an examination of a specimen, representative of the production envisaged full pressure equipment.

3. The manufacturer shall submit an application for EU-type examination with a single notified body of his choice. The application must include:

The name and address of the manufacturer and, if the application is lodged by the authorized representative, the name and address of this.

A written statement which is that the same application has not been lodged with any other notified body.

The technical documentation; the technical documentation shall enable the conformity of the pressure equipment with the applicable requirements of this Royal Decree and shall include an adequate analysis and risk assessment; specify the applicable requirements and cover insofar as relevant for assessment, design, manufacture and operation of the pressure equipment; the technical documentation shall contain, where appropriate, at least the following elements:

A general description of the pressure equipment.

The conceptual design and manufacturing drawings and schemes of components, subassemblies, circuits, etc.

The descriptions and explanations necessary for the understanding of those drawings and diagrams and the operation of the pressure equipment.

A list of harmonized standards, applied in full or in part, whose references have been published in the "Official Journal of the European Union" and, where these have not been applied harmonized standards, the description of the solutions adopted to meet the essential safety requirements of this royal decree; if harmonized standards partly applied, they shall be specified in the technical documentation parts that have been applied.

The results of the design calculations made, examinations carried out, etc.

The test reports.

Corresponding to the tests provided for in manufacture.

The corresponding approvals or qualifications required under sections 3.1.2 and 3.1.3 of Annex I. data

Representative samples of the production envisaged, the sample may include several versions of pressure equipment provided that the differences between them do not affect the level of security. The notified body may request further samples if the test program requires.


Supporting documentation of the adequacy of the technical design; This supporting evidence shall mention any documents that have been used, in particular if the relevant harmonized standards have not been fully implemented; supporting documentation shall include, if necessary, the results of tests conducted in accordance with other relevant technical specifications by the appropriate laboratory of the manufacturer or by another testing laboratory on his behalf and under his responsibility.

4. notified body.

4.1 examine the technical documentation and supporting evidence to assess the adequacy of the technical design of the pressure equipment and manufacturing processes.

In particular, the notified body:

Assess the materials where these are not in conformity with the relevant harmonized standards or with a European approval of pressure equipment materials, and check the certificate issued by the material manufacturer in accordance with the provisions of paragraph 4.3 of Annex I .

Approve methods permanent joining of pressure equipment parts or check that have been previously approved in accordance with paragraph 3.1.2 of Annex I.

Verify that the personnel undertaking the permanent joining of pressure equipment parts and performing 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 were manufactured according to technical documentation, and identify the elements which have been designed in accordance with the applicable provisions of the relevant harmonized standards, as well as elements that are designed using other relevant technical specifications without applying the relevant provisions of those standards.
4.3
make timely examinations and necessary tests to check whether, where the manufacturer has chosen to apply the solutions in the relevant harmonized standards, these solutions have been applied correctly.
4.4
make timely reviews and tests necessary to verify whether, if they have not been applied solutions relevant harmonized standards, the solutions adopted by the manufacturer to apply other relevant technical specifications meet the essential safety requirements corresponding the royal decree.
4.5
agree with the manufacturer the location where the examinations and tests shall be done.

5. The notified body shall establish an evaluation report that records the activities undertaken in accordance with paragraph 4 and their outcomes. Without prejudice to their obligations towards the notifying authority, the notified body shall release 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 a certificate of EU manufacturer exam -type type of production. Notwithstanding paragraph 7, said certificate shall be valid for ten years, is renewable and will include the name and address of the manufacturer, conclusions of the examination, conditions for its validity (if any) and the necessary data to identify the approved type.

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

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

If the type does not satisfy the applicable requirements of this Royal Decree, the notified body shall refuse to issue a certificate of EU type examination -type of production and shall inform the applicant accordingly, giving detailed reasons for its refusal. There should be an appeal procedure.

7. The notified body shall keep itself informed of developments in the current state of the art which indicate that the approved type may no longer comply with the applicable requirements of this Royal Decree, and 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 that holds the technical documentation relating to the certificate of EU type examination on the type of production on any modification of the approved type that may affect the conformity of the pressure equipment with the essential requirements safety royal decree or the conditions of validity of the certificate. Such modifications require additional approval in the form of an addition to the original certificate of EU type examination on the type of production.

8. Each notified body shall inform its notifying authority on EU certificates exam -type type of production and / or any additions thereto which it has issued or withdrawn, and shall, periodically or upon request, make available to its notifying authority the list of such certificates and / or additions thereto refused, suspended or otherwise restricted.

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

The Commission, Member States and the other notified bodies may, on request, obtain a copy of the certificates of EU type examination -type of production or additions. Upon request, the Commission and the Member States may obtain a copy of the technical documentation and the results of examinations conducted by the notified body. The notified body shall keep a copy of the certificate of EU type examination -type of production, its annexes and additions, as well as the technical file including the documentation submitted by the manufacturer until the end of the validity of that certificate.

9. The manufacturer shall keep available for the national authorities a copy of the certificate of EU type examination -type production- its annexes and additions together with the technical documentation for a period of ten years from the introduction of the pressure equipment in the market.

10. The manufacturer's authorized representative may lodge the application referred to in paragraph 3 and fulfill the obligations set out in paragraphs 7 and 9, provided they are specified in the mandate.

II. EU-type examination on the type of design

1. The EU-type examination on the type of design is part of a process of conformity assessment by which a notified body examines the technical design of the pressure equipment and verifies and attests that the technical design meets the requirements of this royal decree.

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

This module design experimental method can not be used as referred to in paragraph 2.2.4 of Annex I.

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

The application must include:

The name and address of the manufacturer and, if the application is lodged by the authorized representative, the name and address of this.

A written statement which is that the same application has not been lodged with any other notified body.

The technical documentation.

The technical documentation shall enable the conformity of the pressure equipment with the applicable requirements of this Royal Decree and will include an analysis and evaluation of appropriate risk; specify the applicable requirements and cover, as far as is relevant for assessment, design, manufacture and operation of the pressure equipment.

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

A general description of the pressure equipment.

The conceptual design and manufacturing drawings and diagrams of components, subassemblies, circuits, etc.

The descriptions and explanations necessary for the understanding of those drawings and diagrams and the operation of the pressure equipment.


A list of harmonized standards, applied in full or in part, whose references have been published in the "Official Journal of the European Union" and, where these have not been applied harmonized standards, the description of the solutions adopted to meet the essential safety requirements of this royal decree; if harmonized standards partly applied, shall be specified in the technical documentation the parties that have been applied, results of design calculations made, examinations carried out, etc.

The information regarding the qualifications or approvals required under sections 3.1.2 and 3.1.3 of Annex I. data

Supporting documentation of the adequacy of the technical design; This supporting evidence shall mention any documents that have been used, in particular if the relevant harmonized standards have not been fully implemented; supporting documentation shall include, if necessary, the results of tests carried out by the appropriate laboratory of the manufacturer, or by another testing laboratory on his behalf and under his responsibility.

The application may cover several versions of pressure equipment provided that the differences between the versions do not affect the level of safety.

4. The notified body is responsible for the following.

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

In particular, the notified body must:

Assess the materials used, if these are not in conformity with the harmonized standards or with a European approval of pressure equipment materials, methods approve permanent joining of pressure equipment parts or check whether they have It has been previously approved in accordance with paragraph 3.1.2 of Annex I.

4.2 Perform appropriate tests to check whether, where the manufacturer has chosen to apply the solutions in the relevant harmonized standards, these solutions have been applied correctly.

4.3 Perform appropriate tests to check whether, if they have not been applied solutions relevant harmonized standards, the solutions adopted by the manufacturer meet the essential safety requirements corresponding Royal Decree.

5. The notified body shall establish an evaluation report that records the activities undertaken in accordance with paragraph 4 and their outcomes. Without prejudice to their obligations with respect to notifying authorities, the notified body shall release 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 issues the manufacturer with a certificate of EU type examination on the type of design. Notwithstanding paragraph 7, the certificate shall be valid for ten years, is renewable and will include the name and address of the manufacturer, conclusions of the examination, conditions for its validity (if any) and the necessary data to identify the approved design.

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

The certificate and its annexes shall contain all relevant information for assessing the conformity of pressure equipment manufactured with the examined and allow in-service control.

If the design does not satisfy the applicable requirements of this Royal Decree, the notified body shall refuse to issue a certificate of EU type examination on the type of design and inform the applicant accordingly, giving detailed reasons for its refusal.

7. The notified body shall keep itself informed of changes in the status of the generally recognized technique which indicate that the approved design may no longer comply with the applicable requirements of this Royal Decree, and 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 that is in possession of the technical documentation relating to the certificate of EU type examination on the type of design on any modification to the approved design that may affect the conformity of the pressure equipment with the essential requirements security of this royal decree or the conditions of validity of the certificate. Such modifications require additional approval in the form of an addition to the original certificate of EU type examination on the type of design.


8. Each notified body shall inform its notifying authority on certificates of EU type examination relating to the type design and / or any additions thereto which it has issued or withdrawn, and shall, periodically or upon request, make available to its notifying authority the list of certificates and / or additions thereto refused, suspended or otherwise restricted.

Each notified body shall inform the other notified bodies of certificates of EU type examination relating to the type design and / or additions thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request on such certificates and / or additions thereto which it has issued.

The Commission, Member States and the other notified bodies may, on request, obtain a copy of the certificates of EU type examination on the type of design or additions. Upon request, the Commission and the Member States may obtain a copy of the technical documentation and the results of examinations conducted by the notified body. The notified body shall keep a copy of the certificate of EU type examination on the type of design, its annexes and additions, as well as the technical file including the documentation submitted by the manufacturer until the end of the validity of the certificate .

9. The manufacturer shall keep at the disposal of the national authorities a copy of the certificate of EU type examination on the type of design, its annexes and additions together with the technical documentation for a period of ten years from the introduction of the team pressure on the market.

10. The manufacturer's authorized representative may lodge the application referred to in paragraph 3 and fulfill the obligations set out in paragraphs 7 and 9, provided they are specified in the mandate.
Module C2


(Conformity to type based on internal production control supervised more control of pressure equipment at random intervals)

1. Concept.

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

2. Manufacturing.

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

3. Final evaluation and monitoring of pressure equipment.

A notified body chosen by the manufacturer shall perform or cause to, product checks at random intervals determined by the body in order to check the quality of the final evaluation and internal controls of pressure equipment are made, taking into account, inter alia, the technological complexity of the equipment and the quantity produced.

The notified body shall ensure that the manufacturer actually performs final assessment in accordance with paragraph 3.2 of Annex I.

An adequate sample of pressure equipment finishing, taken on site by the notified prior to its market introduction body will be examined, and appropriate tests as identified by the relevant parts of the harmonized standards are made and / or equivalent tests established in other technical specifications, to check the conformity of the pressure equipment with the relevant requirements of this royal decree.

The notified body assesses the number of samples to be taken equipment and the need to make or send perform all or part of final assessment on the pressure equipment constituting the sample.

In cases where a sample does not acceptable quality level, 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 performed within acceptable limits in order to ensure compliance team.


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

4. EC and EU declaration of conformity marking.

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

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

A copy of the EU declaration of conformity to the competent authorities be provided upon request.

5. Authorized representative.

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


(Conformity to type based on quality assurance of the production process)

1. Concept.

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

2. Manufacturing.

The manufacturer shall operate an approved quality system for production and for final product inspection and testing of the pressure equipment in question, as specified in paragraph 3 and shall be subject to surveillance that referred to in paragraph 4.

3. Quality system.

3.1 The manufacturer shall lodge an application for assessment of his quality system with a notified body of their choice for pressure equipment concerned body.

The application must include:

The name and address of the manufacturer and, if the application is lodged, the name and address of the authorized representative.

A written statement which is that the same application has not been lodged with any other notified body.

All relevant information on the type of pressure equipment concerned.

The documentation concerning the quality system.

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

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

All the elements, requirements and provisions adopted by the manufacturer shall include documented in a systematic and orderly manner in the form of measures, procedures and instructions, all in writing.

This quality system documentation must permit a consistent interpretation of the programs, plans, manuals and records.

In particular contain an adequate description of:

Quality objectives and the organizational structure, responsibilities and powers of the management in regards to the quality of the pressure equipment.

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

The examinations and tests to be carried out before, during and after manufacture, and the frequency.

The quality records, such as inspection reports, test data and calibration data, reports concerning the qualifications or approval of the personnel concerned and, in particular, the staff responsible for the permanent joining of parts and performing non-destructive tests in accordance with sections 3.1.2 and 3.1.3 of Annex I, etc.

The means with which to monitor the achievement of the required quality and the effective operation of the quality system it is made.

3.3 The notified body must assess the quality system to determine whether it meets the requirements in paragraph 3.2 concerns.


It shall presume conformity with these requirements of the elements of the quality system that comply with the corresponding specifications of the relevant harmonized standard.

Addition to experience in systems quality management, the audit team will have at least one member with experience in the evaluation in the field of pressure equipment and pressure equipment technology concerned and knowledge of the applicable requirements of this royal decree. The audit shall include an inspection visit to the manufacturer's premises.

The auditing team shall review the technical documentation referred to in the fifth indent 3.1 to verify the manufacturer's ability to identify the relevant requirements of this royal decree and make the necessary tests to ensure that the product meets those requirements.

The decision shall be notified to the manufacturer. The notification must contain the conclusions of the audit and the reasoned assessment decision.

3.4 The manufacturer shall undertake to fulfill the obligations arising from the quality system as approved and to maintain it so that it remains adequate and efficient.

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

The notified body must assess the proposed adjustments and decide whether the modified quality system will still satisfy the requirements set out in paragraph 3.2 or whether a reassessment is required.

Notify its decision to the manufacturer. The notification must contain the conclusions of the examination and the reasoned assessment decision.

4. Surveillance under the responsibility of the notified body.

4.1 The purpose of surveillance is to verify that the manufacturer fulfills the obligations imposed by the approved quality system.

4.2 The manufacturer must allow the notified in local manufacturing, inspection, testing and storage body for evaluation purposes, and provide all necessary information, in particular:

The documentation concerning the quality system.

The quality records, such as inspection reports, test data and calibration data, reports on the qualifications of the personnel concerned, etc.

4.3 The notified body shall periodically checked to ensure that the manufacturer maintains and applies the quality system audits, and provide the manufacturer with an audit report. The frequency of periodic audits must be such that every three years carried out a complete reassessment.

4.4 Moreover, the notified body may pay unexpected visits to the manufacturer. The need and frequency of these additional visits will be determined by a control system of visits by the notified body. In the control system views the following factors are taken into account, in particular:

The category of pressure equipment.

The results of previous surveillance visits.

The need to verify compliance with corrective measures.

Where appropriate, special conditions linked to the approval of the system.

The significant changes in manufacturing organization, policy or manufacturing techniques.

During such visits the notified body may carry or have carried out, if necessary, test the product in order to check the proper functioning of the quality system. That body must provide the manufacturer with a visit report and, if a test has taken place, a report of it.

5. EC and EU declaration of conformity marking.

5.1 The manufacturer affixes the CE marking and, under the responsibility of the notified body referred to in paragraph 3.1, the identification number of the latter in each pressure equipment which complies with the type described in the EU test certificate type and satisfies the applicable requirements of this royal decree.

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

A copy of the EU declaration of conformity to the competent authorities be provided upon request.

6. Conservation documentation.


For a period of ten years from the introduction of the pressure equipment on the market, the manufacturer shall make available to the national authorities:

The documentation referred to in paragraph 3.1 refers.

The adaptation section 3.5 has been approved concerns.

Decisions and reports from the notified body referred to in paragraphs 3.3, 3.5, 4.3 and 4.4.

7. Duties of information notified body.

Each notified body shall inform its notifying authority on quality system approvals issued or withdrawn, and shall, periodically or upon request, make available to its notifying authorities the list of quality system approvals refused, suspended or restricted else.

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

8. Authorized representative.

The manufacturer's obligations contained in paragraphs 3.1, 3.5, 5 and 6 may be fulfilled by his authorized representative, on his behalf and under his responsibility, provided that they are specified in the mandate.
Module D1


(Quality assurance of the production process)

1. Concept.

The quality assurance of the production process is the procedure of conformity assessment whereby the manufacturer fulfills the obligations laid down in paragraphs 2, 4 and 7, and ensures and declares on his sole responsibility, that the pressure equipment in question satisfies the requirements of this royal decree that apply.

2. Technical documentation.

The manufacturer shall establish the technical documentation. The documentation possible to assess the pressure equipment meets the relevant requirements, and shall include an analysis and appropriate risk assessment. It will specify the applicable requirements and cover, as far as relevant for assessment, design, manufacture and operation of the product. The technical documentation shall, wherever applicable, at least the following elements:

A general description of the pressure equipment.

The conceptual design and manufacturing drawings and diagrams of components, subassemblies, circuits, etc.

The descriptions and explanations necessary for the understanding of those drawings and diagrams and the operation of the pressure equipment.

A list of harmonized standards, applied in full or in part, whose references have been published in the "Official Journal of the European Union" and, where these have not been applied harmonized standards, the description of the solutions adopted to meet the essential safety requirements of this royal decree; if harmonized standards partly applied, they shall be specified in the technical documentation parts that have been applied.

The results of the design calculations made, examinations carried out, etc.

The test reports.

3. Technical documentation.

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

4. Manufacturing.

The manufacturer shall operate an approved quality system for production and for final product inspection and testing of the pressure equipment in question, as specified in paragraph 5 and shall be subject to surveillance that referred to in paragraph 6.

5. Quality system.

5.1 The manufacturer shall lodge an application for assessment of his quality system with a notified body of their choice for pressure equipment concerned body.

The application must include:

The name and address of the manufacturer and, if the application is lodged by the authorized representative, the name and address of this.

A written statement which is that the same application has not been lodged with any other notified body.

All relevant information on the type of pressure equipment concerned.

The documentation concerning the quality system.

The technical documentation referred to in paragraph 2.

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


All the elements, requirements and provisions adopted by the manufacturer shall include documented in a systematic and orderly manner in the form of measures, procedures and instructions, all in writing. The quality system documentation must permit a consistent interpretation of the programs, plans, manuals and records.

In particular contain an adequate description of:

Quality objectives and the organizational structure, responsibilities and powers of the management in regards to the quality of the pressure equipment.

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

The examinations and tests to be carried out before, during and after manufacture, and the frequency.

The quality records, such as inspection reports, test data and calibration data, reports concerning the qualifications or approval of the personnel concerned and, in particular, the staff responsible for the permanent joining of parts in accordance with section 3.1.2 of Annex I, etc.

The means with which to monitor the achievement of the required product quality and the effective operation of the quality system is made.

5.3 The notified body must assess the quality system to determine whether it meets the requirements of section 5.2 refers to. They are presumed to comply with the corresponding requirements prescribed in section 5.2 of those elements of the quality system that comply with the relevant harmonized standard.

Addition to experience in systems quality management, the audit team will have at least one member with experience in assessing the pressure equipment technology concerned, and knowledge of the applicable requirements the royal decree. The audit shall include an assessment visit to the manufacturer's premises.

The auditing team shall review the technical documentation referred to in paragraph 2 to verify the manufacturer's ability to identify the relevant requirements of this royal decree and make the necessary tests to ensure that the pressure equipment satisfies those requirements .

The decision shall be notified to the manufacturer. The notification must contain the conclusions of the audit and the reasoned assessment decision.

5.4 The manufacturer shall undertake to fulfill the obligations arising from the quality system as approved and to maintain it so that it remains adequate and efficient.

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

The notified body must assess the proposed adjustments and decide whether the modified quality system will still satisfy the requirements set out in paragraph 5.2 or whether a reassessment is required.

Notify its decision to the manufacturer. The notification must contain the conclusions of the examination and the reasoned assessment decision.

6. Surveillance under the responsibility of the notified body.

6.1 The purpose of monitoring is to verify that the manufacturer fulfills the obligations imposed by the approved quality system.

6.2 The manufacturer must allow the notified in local manufacturing, inspection, testing and storage body for evaluation purposes, and provide all necessary information, in particular:

The documentation concerning the quality system.

The technical documentation referred to in paragraph 2.

The quality records, such as inspection reports, test data and calibration data, reports on the qualifications of the personnel concerned, etc.

6.3 The notified body shall periodically checked to ensure that the manufacturer maintains and applies the quality system audits, and provide the manufacturer with an audit report. The frequency of periodic audits must be such that every three years carried out a complete reassessment.

6.4 Moreover, the notified body may pay unexpected visits to the manufacturer. The need and frequency of these additional visits will be determined by a control system of visits by the notified body. In the control system views the following factors are taken into account, in particular:

The category of pressure equipment.

The results of previous surveillance visits.


The need to verify compliance with corrective measures.

Where appropriate, special conditions linked to the approval of the system.

The significant changes in manufacturing organization, policy or manufacturing techniques.

During such visits the notified body may carry or have carried out, if considered necessary, testing of products in order to check the proper functioning of the quality system. That body must provide the manufacturer with a visit report and, if a test has taken place, a report of it.

7. EC and EU declaration of conformity marking.

7.1 The manufacturer affixes the CE marking and, under the responsibility of the notified body referred to in paragraph 5.1, the identification number of the latter in each pressure equipment that satisfies the applicable requirements of this Royal Decree.

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

A copy of the EU declaration of conformity to the competent authorities be provided upon request.

8. Conservation documentation.

For a period of ten years from the introduction of the pressure equipment on the market, the manufacturer shall make available to the national authorities:

The documentation referred to in paragraph 5.1 refers.

The adaptation section 5.5 concerns.

Decisions and reports from the notified body referred to in paragraphs 5.5, 6.3 and 6.4.

9. Duties of information notified body.

Each notified body shall inform its notifying authority on quality system approvals issued or withdrawn, and shall, periodically or upon request, make available to its notifying authorities the list of quality system approvals refused, suspended or restricted else.

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

10. Authorized representative.

The manufacturer's obligations contained in paragraphs 3, 5.1, 5.5, 7 and 8 may be fulfilled by his authorized representative, on his behalf and under his responsibility, provided that they are specified in the mandate.
Module E


(Conformity to type based on quality assurance of pressure equipment)

1. Concept.

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

2. Manufacturing.

The manufacturer shall operate an approved quality system for final product inspection and testing of the pressure equipment in question, as specified in paragraph 3 and shall be subject to surveillance in paragraph 4. refers to | ||
3. Quality system.

3.1 The manufacturer shall lodge an application for assessment of his quality system with a notified body of their choice for pressure equipment concerned body.

The application must include:

The name and address of the manufacturer and, if the application is lodged by the authorized representative, the name and address of this.

A written statement which is that the same application has not been lodged with any other notified body.

All relevant information on the type of pressure equipment concerned.

The documentation concerning the quality system.

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

3.2 The quality system shall ensure that products conform to the type described in the certificate of EU type examination and satisfy the requirements of this Royal Decree which apply.


All the elements, requirements and provisions adopted by the manufacturer shall include documented in a systematic and orderly manner in the form of measures, procedures and instructions, all in writing. The quality system documentation must permit a consistent interpretation of the programs, plans, manuals and records.

In particular contain an adequate description of:

Quality objectives and the organizational structure, responsibilities and powers of the management in regards to the quality of the products.

The examinations and tests to be carried out after manufacture.

The quality records, such as inspection reports, test data and calibration data, reports concerning the qualifications or approval of the personnel concerned and, in particular, the person l undertaking the permanent union of the parties and performing non-destructive testing in accordance with sections 3.1.2 and 3.1.3 of Annex I.

The means by that monitoring the effective operation of the quality system is made.

3.3 The notified body must assess the quality system to determine whether it meets the requirements in paragraph 3.2 concerns. It shall presume conformity with these requirements of the elements of the quality system that comply with the corresponding specifications of the relevant harmonized standard.

Addition to experience in systems quality management, the audit team will have at least one member with experience of evaluation in the field and pressure equipment technology concerned, and knowledge of the applicable requirements of this royal decree. The audit shall include an assessment visit to the manufacturer's premises.

The auditing team shall review the technical documentation referred to in paragraph 3.1, fifth indent to verify the manufacturer's ability to identify the relevant requirements of this Royal Decree and make the necessary tests to ensure that the equipment pressure meets those requirements.

The decision shall be notified to the manufacturer. The notification must contain the conclusions of the audit and the reasoned assessment decision.

3.4 The manufacturer shall undertake to fulfill the obligations arising from the quality system as approved and to maintain it so that it remains adequate and efficient.

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

The notified body must assess the proposed adjustments and decide whether the modified quality system will still satisfy the requirements preceptuados in paragraph 3.2 or whether a reassessment is required.

Notify its decision to the manufacturer. The notification must contain the conclusions of the examination and the reasoned assessment decision.

4. Surveillance under the responsibility of the notified body.

4.1 The purpose of surveillance is to verify that the manufacturer fulfills the obligations imposed by the approved quality system.

4.2 The manufacturer must allow the notified in local manufacturing, inspection, testing and storage body for evaluation purposes, and provide all necessary information, in particular:

The documentation concerning the quality system.

The technical documentation.

The quality records, such as inspection reports, test data and calibration data, reports on the qualifications of the personnel concerned, etc.

4.3 The notified body shall periodically checked to ensure that the manufacturer maintains and applies the quality system audits, and provide the manufacturer with an audit report. The frequency of periodic audits must be such that every three years carried out a complete reassessment.

4.4 Moreover, the notified body may pay unexpected visits to the manufacturer.

The need and frequency of these additional visits will be determined by a control system of visits by the notified body. In the control system views the following factors are taken into account, in particular:

The category of pressure equipment.

The results of previous surveillance visits.

The need to verify compliance with corrective measures.

Where appropriate, special conditions linked to the approval of the system.

The significant changes in manufacturing organization, policy or manufacturing techniques.


During such visits the notified body may carry or have carried out, if considered necessary, testing of products in order to check the proper functioning of the quality system. That body must provide the manufacturer with a visit report and, if a test has taken place, a report of it.

5. EC and EU declaration of conformity marking.

5.1 The manufacturer affixes the CE marking and, under the responsibility of the notified body referred to in paragraph 3.1, the identification number of the latter in each pressure equipment which complies with the type described in the EU test certificate type and satisfies the applicable requirements of this royal decree.

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

A copy of the EU declaration of conformity to the competent authorities be provided upon request.

6. Retention of documents.

For a period of ten years from the introduction of the pressure equipment on the market, the manufacturer shall make available to the national authorities:

The documentation referred to in paragraph 3.1 refers.

The adaptation section 3.5 has been approved concerns.

Decisions and reports from the notified body referred to in paragraphs 3.3, 3.5, 4.3 and 4.4.

7. Duties of information notified body.

Each notified body shall inform its notifying authority on quality system approvals issued or withdrawn, and shall, periodically or upon request, make available to its notifying authorities the list of quality system approvals refused, suspended or restricted else.

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

8. Authorized representative.

The manufacturer's obligations contained in paragraphs 3.1, 3.5, 5 and 6 may be fulfilled by his authorized representative, on his behalf and under his responsibility, provided that they are specified in the mandate.
Module E1


(Quality assurance inspection and testing of pressure equipment finish)

1. Concept.

The quality assurance inspection and testing of pressure equipment to finish the procedure of conformity assessment whereby the manufacturer fulfills the obligations laid down in paragraphs 2, 4 and 7, and ensures and declares, under their sole responsibility that the pressure equipment in question satisfies the requirements of this royal decree that apply.

2. Technical documentation.

The manufacturer shall establish the technical documentation. The technical documentation possible to assess the pressure equipment meets the relevant requirements and include an analysis and appropriate risk assessment. The technical documentation shall specify the applicable requirements and cover, as far as relevant for assessment, design, manufacture and operation of the pressure equipment. The technical documentation shall, wherever applicable, at least the following elements:

A general description of the pressure equipment.

The conceptual design and manufacturing drawings and diagrams of components, subassemblies, circuits, etc.

The descriptions and explanations necessary for the understanding of those drawings and diagrams and the operation of the pressure equipment.

A list of harmonized standards, applied in full or in part, whose references have been published in the "Official Journal of the European Union" and, where these have not been applied harmonized standards, the description of the solutions adopted to meet the essential safety requirements of this royal decree; if harmonized standards partly applied, they shall be specified in the technical documentation parts that have been applied.

The results of the design calculations made, examinations carried out, etc.

The test reports.

3. Technical documentation.

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

4. Manufacturing.


The manufacturer shall operate an approved quality system for final product inspection and testing of the pressure equipment in question, as specified in paragraph 5 and shall be subject to monitoring in paragraph 6. refers to | ||
5. Quality system.

5.1 The manufacturer shall lodge an application for assessment of his quality system with a notified body of their choice for pressure equipment concerned body.

The application must include:

The name and address of the manufacturer and, if the application is lodged by the authorized representative, the name and address of this.

A written statement which is that the same application has not been lodged with any other notified body.

All relevant information on the type of pressure equipment concerned.

The documentation concerning the quality system.

The technical documentation referred to in paragraph 2.

5.2 The quality system shall ensure that the pressure equipment satisfies the requirements of this Royal Decree which apply.
Each team will examine
In the context of the quality system, and pressure tests as the standard or the relevant rules established in Article 12, or equivalent tests shall be performed, and in particular, the final assessment referred in paragraph 3.2 of Annex I, in order to ensure its conformity with the requirements of this royal decree apply to it.

All the elements, requirements and provisions adopted by the manufacturer shall include documented in a systematic and orderly manner in the form of measures, procedures and instructions, all in writing. The quality system documentation must permit a consistent interpretation of the programs, plans, manuals and records.

In particular contain an adequate description of:

Quality objectives and the organizational structure, responsibilities and powers of the management in regards to the quality of the pressure equipment.

Procedures approved joining of parts in accordance with section 3.1.2 of Annex I.

The examinations and tests to be carried out after manufacture.

The quality records, such as inspection reports, test data and calibration data, reports concerning the qualifications or approval of the personnel concerned and, in particular, the staff responsible for the permanent joining of parts in accordance with section 3.1.2 of Annex I.

The means by that monitoring the effective operation of the quality system is made.

5.3 The notified body must assess the quality system to determine whether it meets the requirements of section 5.2 refers to.

It shall presume conformity with these requirements of the elements of the quality system that comply with the corresponding specifications of the relevant harmonized standard.

Addition to experience in systems quality management, the audit team will have at least one member with experience in the evaluation in the field of pressure equipment and pressure equipment technology concerned and knowledge of the applicable requirements of this royal decree. The audit shall include an assessment visit to the manufacturer's premises.

The auditing team shall review the technical documentation referred to in paragraph 2 to verify the manufacturer's ability to identify the relevant requirements of this royal decree and make the necessary tests to ensure that the pressure equipment satisfies those requirements .

The decision shall be notified to the manufacturer. The notification must contain the conclusions of the audit and the reasoned assessment decision.

5.4 The manufacturer shall undertake to fulfill the obligations arising from the quality system as approved and to maintain it so that it remains adequate and efficient.

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

The notified body must assess the proposed adjustments and decide whether the modified quality system will still satisfy the requirements preceptuados in paragraph 5.2 or whether a reassessment is required.

Notify its decision to the manufacturer. The notification must contain the conclusions of the examination and the reasoned assessment decision.

6. Surveillance under the responsibility of the notified body.

6.1 The purpose of monitoring is to verify that the manufacturer fulfills the obligations imposed by the approved quality system.


6.2 The manufacturer must allow the notified in local manufacturing, inspection, testing and storage body for evaluation purposes, and provide all necessary information, in particular:

The documentation concerning the quality system.

The technical documentation referred to in paragraph 2.

The quality records, such as inspection reports, test data and calibration data, reports on the qualifications of the personnel concerned, etc.

6.3 The notified body shall periodically checked to ensure that the manufacturer maintains and applies the quality system audits, and provide the manufacturer with an audit report. The frequency of periodic audits must be such that every three years carried out a complete reassessment.

6.4 Moreover, the notified body may pay unexpected visits to the manufacturer. The need and frequency of these additional visits will be determined by a control system of visits by the notified body. In the control system views the following factors are taken into account, in particular:

The equipment category.

The results of previous surveillance visits.

The need to verify compliance with corrective measures.

Where appropriate, special conditions linked to the approval of the system.

The significant changes in manufacturing organization, policy or manufacturing techniques.

During such visits the notified body may carry or have carried out, if considered necessary, testing of products in order to check the proper functioning of the quality system. That body must provide the manufacturer with a visit report and, if a test has taken place, a report of it.

7. EC and EU declaration of conformity marking.

7.1 The manufacturer affixes the CE marking and, under the responsibility of the notified body referred to in paragraph 5.1, the identification number of the latter in each pressure equipment that satisfies the applicable requirements of this Royal Decree.

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

A copy of the EU declaration of conformity to the competent authorities be provided upon request.

8. Conservation documentation.

For a period of ten years from the introduction of the pressure equipment on the market, the manufacturer shall make available to the national authorities:

The documentation referred to in paragraph 5.1 refers.

The adaptation section 5.5 has been approved concerns.

Decisions and reports from the notified body referred to in paragraphs 5.3, 5.5, 6.3 and 6.4.

9. Duties of information notified body.

Each notified body shall inform its notifying authority on quality system approvals issued or withdrawn, and shall, periodically or upon request, make available to its notifying authorities the list of quality system approvals refused, suspended or restricted else.

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

10. Authorized representative.

The manufacturer's obligations contained in paragraphs 3, 5.1, 5.5, 7 and 8 may be fulfilled by his authorized representative, on his behalf and under his responsibility, provided that they are specified in the mandate.
Module F


(Conformity to type based on verification of pressure equipment)

1. Concept.

Conformity to type based on the verification of the pressure equipment is part of a process of conformity assessment whereby the manufacturer fulfills the obligations laid down in paragraphs 2 and 5, and ensures and declares on his sole responsibility that the pressure equipment in question, which conforms to the provisions of paragraph 3, is in conformity with the type described in the certificate of EU type examination and satisfies the requirements of this royal decree that apply.

2. Manufacturing.


The manufacturer must take all necessary measures for the manufacturing process and its monitoring ensure conformity of manufactured products with the type described in the certificate of EU type examination and the requirements of this Royal Decree that apply to them .

3. Check.

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

The examinations and tests to check the conformity of the pressure equipment with the relevant requirements will be carried out by examination and testing of every product as specified in paragraph 4.

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

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

In particular, the notified body:

Verify whether the staff responsible for the permanent joining of parts and performing non-destructive tests are qualified or approval referred to in paragraphs 3.1.2 and 3.1.3 of Annex I.

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

Perform or final inspection and the overload test specified in paragraph 3.2 of Annex I are 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 affix its identification number to each approved pressure equipment, or will it affixed under its responsibility.

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

5. EC and EU declaration of conformity marking.

5.1 The manufacturer affixes the CE marking and, under the responsibility of the notified body referred to in paragraph 3, the identification number of the latter in each pressure equipment which is in conformity with the approved type described in the examination certificate EU type and satisfies the applicable requirements of this royal decree.

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

A copy of the EU declaration of conformity to the competent authorities be provided upon request.

If so agreed by the notified body referred to in paragraph 3, the manufacturer shall also affix the pressure equipment identification number of the notified body, under the responsibility of this.

6. The manufacturer may, if agreed upon by the notified body and under its responsibility, placing the identification number of the notified body pressure equipment during the manufacturing process.

7. Authorized representative.

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


(Conformity based on unit verification)

1. Concept.

Conformity based on unit verification is the procedure of conformity assessment whereby the manufacturer fulfills the obligations laid down in paragraphs 2, 3 and 5, and ensures and declares on his sole responsibility that the equipment pressure in question, which conforms to the provisions of paragraph 4 complies with the requirements of this royal decree that apply.

2. Technical documentation.

The manufacturer shall establish the technical documentation and make it available to the notified body paragraph 4 refers to


The documentation possible to assess the pressure equipment meets the relevant requirements, and shall include an analysis and appropriate risk assessment. It will specify the applicable requirements and cover, as far as relevant for assessment, design, manufacture and operation of the pressure equipment.

The technical documentation shall, wherever applicable, at least the following elements:

A general description of the pressure equipment.

The conceptual design and manufacturing drawings and diagrams of components, subassemblies, circuits, etc.

The descriptions and explanations necessary for the understanding of those drawings and diagrams and the operation of the pressure equipment.

A list of harmonized standards, applied in full or in part, whose references have been published in the "Official Journal of the European Union" and, where these have not been applied harmonized standards, the description of the solutions adopted to meet the essential safety requirements of this royal decree; if harmonized standards partly applied, they shall be specified in the technical documentation parts that have been applied.

The results of the design calculations made, examinations carried out, etc.

The test reports.

Appropriate details relating to the approval of the manufacturing processes and testing and qualification or approval of the personnel 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 ten years from the introduction of the pressure equipment on the market.

3. Manufacturing.

The manufacturer must take all necessary measures for the manufacturing process and its monitoring ensure conformity of the manufactured pressure equipment with the applicable requirements of this Royal Decree.

4. Check.

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

In particular, the notified body:

Examine the technical documentation with respect to the design and manufacturing processes.

Assess the materials used where these are not in conformity with the harmonized standards or with a European approval of pressure equipment materials, and check the certificate issued by the material manufacturer, in accordance with paragraph 4.3 Annex I.

Approve methods permanent joining of parts or check that have been previously approved in accordance with paragraph 3.1.2 of Annex I.

Verify the qualifications or approvals required under sections 3.1.2 and 3.1.3 of Annex I.

It will proceed to the final inspection referred to in paragraph 3.2.1 of Annex I, perform or cause to perform the test provisions in paragraph 3.2.2 of Annex I and, where appropriate, examine the safety devices.

The notified body shall issue a certificate of conformity concerning the examinations and tests carried out and affix its identification number to each approved pressure equipment, or will it affixed under its responsibility. The manufacturer shall keep the certificates of conformity available for the national authorities for a period of ten years from the introduction of the pressure equipment on the market.

5. EC and EU declaration of conformity marking.

5.1 The manufacturer affixes the CE marking and, under the responsibility of the notified body referred to in paragraph 4, the identification number of the latter in each pressure equipment that satisfies the applicable requirements of this 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 ten years from the introduction of the pressure equipment on the market. The EU declaration of conformity shall identify pressure equipment for which it has been prepared.

A copy of the EU declaration of conformity to the competent authorities be provided upon request.

6. Authorized representative.


The manufacturer's obligations contained in paragraphs 2 and 5 may be fulfilled by his authorized representative, on his behalf and under his responsibility, provided they are specified in the mandate.
Module H


(Conformity based on full quality assurance)

1. Concept.

Conformity based on full quality assurance is the procedure of conformity assessment whereby the manufacturer fulfills the obligations laid down in paragraphs 2 and 5, and ensures and declares on his sole responsibility that the equipment pressure in question meets the requirements of this royal decree that apply.

2. Manufacturing.

The manufacturer shall operate an approved quality system for design, manufacture, inspection of finished products and testing of pressure equipment, as specified in paragraph 3 and shall be subject to surveillance as regards 4. paragraph

3. Quality system.

3.1 The manufacturer shall lodge an application for assessment of his quality system with a notified body of their choice for pressure equipment concerned body.

The application must include:

The name and address of the manufacturer and, if the application is lodged by the authorized representative, the name and address of this.

The technical documentation for one model of each type of pressure equipment to be manufactured.

The technical documentation shall, wherever applicable, at least the following elements:

A general description of the pressure equipment.

The conceptual design and manufacturing drawings and diagrams of components, subassemblies, circuits, etc.

The descriptions and explanations necessary for the understanding of those drawings and diagrams and the operation of the pressure equipment.

A list of harmonized standards, applied in full or in part, whose references have been published in the "Official Journal of the European Union" and, where these have not been applied harmonized standards, the description of the solutions adopted to meet the essential safety requirements of this royal decree; if harmonized standards partly applied, they shall be specified in the technical documentation parts that have been applied.

The results of the design calculations made, examinations carried out, etc.

The test reports.

The documentation concerning the quality system.

A written statement which is that the same application has not been lodged with any other notified body.

3.2 The quality system shall ensure that the pressure equipment satisfies the requirements of this royal decree apply to them.

All the elements, requirements and provisions adopted by the manufacturer shall include documented in a systematic and orderly manner in the form of measures, procedures and instructions, all in writing. This quality system documentation must permit a consistent interpretation of the programs, plans, manuals and records.

In particular contain an adequate description of:

Quality objectives and the organizational structure, responsibilities and powers of the management in regards to design and product quality.

The technical design specifications, including standards that will be applied and, if relevant harmonized standards are not applied in full, the means that will be used to ensure that the essential requirements of this royal decree are satisfied that they apply to the pressure equipment.

Techniques, processes and systematic measures to control and design verification that will be used when designing the pressure equipment belonging to the type of product in question, in particular as regards materials, accordance with paragraph 4 of Annex I.

The corresponding techniques, processes and systematic actions manufacturing, quality control and quality assurance that will be used, particularly the procedures for the permanent joining of parts as approved in accordance with paragraph 3.1.2 of Annex I.

The examinations and tests to be carried out before, during and after manufacture, and the frequency.

The quality records, such as inspection reports, test data and calibration data, reports concerning the qualifications or approval of the personnel concerned and, in particular, the staff responsible for the permanent joining of parts and performing non-destructive testing as referred to in paragraphs 3.1.2 and 3.1.3 of Annex I, etc.


The means with which to monitor the achievement of design and quality of the equipment required pressure and the effective operation of the quality system is made.

3.3 The notified body must assess the quality system to determine whether it meets the requirements in paragraph 3.2 concerns. It shall presume conformity with these requirements of the elements of the quality system that comply with the corresponding specifications of the relevant harmonized standard.

Addition to experience in systems quality management, the audit team will have at least one member with experience as an evaluator of the pressure equipment technology concerned, and knowledge of the applicable requirements this royal decree. The audit shall include an assessment visit to the manufacturer's premises.

The auditing team shall review the technical documentation referred to in paragraph 1, second indent, to verify the manufacturer's ability to identify the relevant requirements of this Royal Decree and make the necessary tests to ensure that the equipment pressure meets those requirements.

The decision to the manufacturer or its authorized representative shall be notified. The notification must contain the conclusions of the audit and the reasoned assessment decision.

3.4 The manufacturer shall undertake to fulfill the obligations arising from the quality system as approved and to maintain it so that it remains adequate and efficient.

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

The notified body must assess the proposed adjustments and decide whether the modified quality system will still satisfy the requirements preceptuados in paragraph 3.2 or whether a reassessment is required.

Notify its decision to the manufacturer. The notification must contain the conclusions of the examination and the reasoned assessment decision.

4. Surveillance under the responsibility of the notified body.

4.1 The purpose of surveillance is to verify that the manufacturer fulfills the obligations imposed by the approved quality system.

4.2 The manufacturer must allow the notified local design, manufacture, inspection, testing and storage body for evaluation purposes, and provide all necessary information, in particular:

The documentation concerning the quality system.

The quality records provided for in the part of the quality system design, such as results of analyzes, calculations, tests, etc.

The quality records provided for in the part of the quality system to manufacture, such as inspection reports, test data and calibration data, reports on the qualifications of the personnel concerned, etc.

4.3 The notified body shall periodically checked to ensure that the manufacturer maintains and applies the quality system audits, and provide the manufacturer with an audit report. The frequency of periodic audits must be such that every three years carried out a complete reassessment.

4.4 Moreover, the notified body may pay unexpected visits to the manufacturer.

The need and frequency of these additional visits will be determined by a control system of visits by the notified body. In the control system views the following factors are taken into account, in particular:

The equipment category.

The results of previous surveillance visits.

The need to verify compliance with corrective measures.

Where appropriate, special conditions linked to the approval of the system.

The significant changes in manufacturing organization, policy or manufacturing techniques.

During such visits the notified body may carry or have carried out, if considered necessary, testing of products in order to check the proper functioning of the quality system. That body must provide the manufacturer with a visit report and, if a test has taken place, a report of it.

5. EC and EU declaration of conformity marking.

5.1 The manufacturer affixes the CE marking and, under the responsibility of the notified body referred to in paragraph 3.1, the identification number of the latter in 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 each model of pressure equipment and keep it at the disposal of the national authorities for a period of ten years from the introduction of the pressure equipment on the market. The EU declaration of conformity shall identify computer model pressure for which it has been prepared.

A copy of the EU declaration of conformity to the competent authorities be provided upon request.

6. Conservation documentation.

For a period of ten years from the introduction of the pressure equipment on the market, the manufacturer shall make available to the national authorities:

The technical documentation section 3.1 concerns.

The documentation concerning the quality system referred to in paragraph 3.1.

The adaptation section 3.4 has been approved concerns.

Decisions and reports from the notified body referred to in paragraphs 3.3, 3.4, 4.3 and 4.4.

7. Duties of information notified body.

Each notified body shall inform its notifying authority on quality system approvals issued or withdrawn, and shall, periodically or upon request, make available to its notifying authorities the list of quality system approvals refused, suspended or restricted else.

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

8. Authorized representative

The manufacturer's obligations contained in paragraphs 3.1, 3.5, 5 and 6 may be fulfilled by his authorized representative, on his behalf and under his responsibility, provided that they are specified in the mandate.
Module H1


(Conformity based on full quality assurance plus design examination)

1. Concept.

Conformity based on full quality assurance plus design examination and special surveillance of the final assessment is the procedure of conformity assessment whereby the manufacturer fulfills the obligations laid down in paragraphs 2 and 6, and ensures and declares on his sole responsibility that the pressure equipment concerned satisfy the requirements of the Directive which apply to them.

2. Manufacturing.

The manufacturer shall operate an approved quality system for design and manufacturing, as well as for finished products inspection and testing of the products concerned, as specified in paragraph 3 and shall be subject to surveillance 5. in paragraph refers to the adequacy of the technical design of the pressure equipment it will have been examined under the provisions of paragraph 4.

3. Quality system.

3.1 The manufacturer shall lodge an application for assessment of his quality system with a notified body of their choice for pressure equipment concerned body.

The application must include:

The name and address of the manufacturer and, if the application is lodged by the authorized representative, the name and address of this.

The technical documentation for one model of each type of pressure equipment to be manufactured.

The technical documentation shall, wherever applicable, at least the following elements:

A general description of the pressure equipment.

The conceptual design and manufacturing drawings and diagrams of components, subassemblies, circuits, etc.

The descriptions and explanations necessary for the understanding of those drawings and diagrams and the operation of the pressure equipment.

A list of harmonized standards, applied in full or in part, whose references have been published in the "Official Journal of the European Union" and, where these have not been applied harmonized standards, the description of the solutions adopted to meet the essential safety requirements of this royal decree; if harmonized standards partly applied, they shall be specified in the technical documentation parts that have been applied.

The results of the design calculations made, examinations carried out, etc.

The test reports.

The documentation concerning the quality system.

A written statement which is that the same application has not been lodged with any other notified body.

3.2 The quality system shall ensure that the pressure equipment satisfies the requirements of this royal decree apply to them.


All the elements, requirements and provisions adopted by the manufacturer shall include documented in a systematic and orderly manner in the form of measures, procedures and instructions, all in writing. The quality system documentation must permit a consistent interpretation of the programs, plans, manuals and records.

In particular contain an adequate description of:

Quality objectives and the organizational structure, responsibilities and powers of the management in regards to design and product quality.

The technical design specifications, including standards that will be applied and, if relevant harmonized standards will not be fully applied, the means by which compliance with the essential safety requirements of this royal will ensure decree applicable to pressure equipment.

Control techniques and design verification, processes and systematic actions that will be used when designing the pressure equipment belonging to the type of pressure equipment concerned, in particular as regards materials in accordance with paragraph 4 of Annex I.

The corresponding techniques, processes and systematic actions manufacturing, quality control and quality assurance that will be used, particularly the procedures for the permanent joining of parts as approved in accordance with paragraph 3.1.2 of Annex I.

The examinations and tests to be carried out before, during and after manufacture, and the frequency.

The quality records, such as inspection reports, test data and calibration data, reports concerning the qualifications or approval of the personnel concerned, particularly the staff responsible for the permanent joining of parts and performing non-destructive testing in accordance with sections 3.1.2 and 3.1.3 of Annex I, etc.

The means with which to monitor the achievement of design and quality of the equipment required pressure and the effective operation of the quality system is made.

3.3 The notified body must assess the quality system to determine whether it meets the requirements in paragraph 3.2 concerns.

It shall presume conformity with these requirements of the elements of the quality system that comply with the corresponding specifications of the relevant harmonized standard. In addition to experience in systems quality management, the audit team will have at least one member with experience as an assessor in the field of pressure equipment and technology pressure equipment concerned, and knowledge of the applicable requirements of this royal decree. The audit shall include an assessment visit to the manufacturer's premises.

The auditing team shall review the technical documentation referred to in paragraph 3.1, second indent, to verify the manufacturer's ability to identify the relevant requirements of this Royal Decree and make the necessary tests to ensure that the equipment pressure meets those requirements.

The decision to the manufacturer or its authorized representative shall be notified.

The notification must contain the conclusions of the audit and the reasoned assessment decision.

3.4 The manufacturer shall undertake to fulfill the obligations arising from the quality system as approved and to maintain it so that it remains adequate and efficient.

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

The notified body must assess the proposed adjustments and decide whether the modified quality system will still satisfy the requirements preceptuados in paragraph 3.2 or whether a reassessment is required.

Notify its decision to the manufacturer. The notification must contain the conclusions of the examination and the reasoned assessment decision.

3.6 Each notified body shall inform its notifying authority on quality system approvals issued or withdrawn, and shall, periodically or upon request, make available to its notifying authorities the list of quality system approvals refused, suspended or otherwise restricted.

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

4. Design examination.


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 a previous review.

4.2 The application will enable the design, manufacture and operation of the pressure equipment and assess compliance with the requirements of this Royal Decree that apply. It shall include:

The name and address of the manufacturer.

A written statement which is that the same application has not been lodged with any other notified body.

The technical documentation. The documentation possible to assess the pressure equipment meets the relevant requirements and include an analysis and appropriate risk assessment. You specify the applicable requirements and shall include, to the extent it is relevant for such assessment, design and operation of the pressure equipment.

The technical documentation shall, wherever applicable, at least the following elements:

A general description of the pressure equipment.

The conceptual design and manufacturing drawings and diagrams of components, subassemblies, circuits, etc.

The descriptions and explanations necessary for the understanding of those drawings and diagrams and the operation of the pressure equipment.

A list of harmonized standards, applied in full or in part, whose references have been published in the "Official Journal of the European Union" and, where these have not been applied harmonized standards, the description of the solutions adopted to meet the essential safety requirements of this royal decree; if harmonized standards partly applied, they shall be specified in the technical documentation parts that have been applied.

The results of the design calculations made, examinations carried out, etc.

The test reports.

Supporting documentation of the adequacy of the technical design. Such evidence shall mention any documents that have been used, especially if they have not fully implemented the relevant harmonized standards, and include, if necessary, the results of tests carried out by the appropriate laboratory of the manufacturer or another laboratory that conducted the testing on his behalf and under his responsibility.

4.3 The notified body must examine the application and where the design meets the requirements of this royal decree apply to the pressure equipment will issue a certificate of EU design examination manufacturer. Such certificate shall contain the name and address of the manufacturer, conclusions of the examination, the conditions of validity (if any) and the data necessary to identify the approved design. They may attach one or more attachments certificate.

The certificate and its annexes shall contain all relevant information for assessing the conformity of manufactured products with the examined and allow in-service control, where applicable information.

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, giving detailed reasons for its refusal.

4.4 The notified body shall keep informed of changes in the state of the art generally recognized to indicate that the approved design may no longer comply with the applicable requirements of this Royal Decree, and determine whether such changes require further investigations. In that case, the notified body shall inform the manufacturer accordingly.

The manufacturer shall keep the notified body that issued the EU design certificate examination of any modification to the approved that may affect conformity with the essential requirements of this Royal 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 as certificate added to the original EU design examination.

4.5 Each notified body shall inform its notifying authority on certificates of EU design examination and / or any additions thereto which it has issued or withdrawn, and shall, periodically or upon request, make available to its notifying authority the list certificates and / or additions thereto refused, suspended or otherwise restricted.


Each notified body shall inform the other notified bodies of certificates of EU design examination and / or the additions thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, concerning the certificates and / or additions thereto which it has issued.

The Commission, Member States and the other notified bodies may, on request, obtain a copy of the certificates of EU design examination or additions. Upon request, the Commission and the Member States may obtain a copy of the technical documentation and the results of examinations conducted by the notified body.

The notified body shall keep a copy of the certificate of EU design examination, its annexes and additions, as well as the technical file including the documentation submitted by the manufacturer until the end of the validity of the certificate.

4.6 The manufacturer shall keep available for the national authorities a copy of the certificate of EU design examination, its annexes and additions together with the technical documentation for a period of ten years from the introduction of the pressure equipment in the market.

5. Surveillance under the responsibility of the notified body.

5.1 The purpose of surveillance is to verify that the manufacturer fulfills the obligations imposed by the approved quality system.

5.2 The manufacturer must allow the notified local design, manufacture, inspection, testing and storage body for evaluation purposes, and provide all necessary information, in particular:

The documentation concerning the quality system.

The quality records provided for in the part of the quality system design, such as results of analyzes, calculations, tests, etc.

The quality records provided for in the part of the quality system to manufacture, such as inspection reports, test data and calibration data, reports on the qualifications of the personnel concerned, etc.

5.3 The notified body shall periodically checked to ensure that the manufacturer maintains and applies the quality system audits, and provide the manufacturer with an audit report. The frequency of periodic audits must be such that every three years carried out a complete reassessment.

5.4 Moreover, the notified body may pay unexpected visits to the manufacturer.

The need and frequency of these additional visits will be determined by a control system of visits by the notified body. In the control system views the following factors are taken into account, in particular:

The equipment category.

The results of previous surveillance visits.

The need to verify compliance with corrective measures.

Where appropriate, special conditions linked to the approval of the system.

The significant changes in manufacturing organization, policy or manufacturing techniques.

During such visits the notified body may carry or have carried out, if considered necessary, testing of products in order to check the proper functioning of the quality system. That body must provide the manufacturer with a visit report and, if a test has taken place, a report of it.

5.5 Special surveillance of the final assessment.

The final evaluation in paragraph 3.2 of Annex I refers to be subject to increased surveillance in unannounced visits by the notified body. During such visits, the notified body shall carry out tests pressure equipment.

Notified body must provide the manufacturer with a visit report and, if a test has taken place, a report of it.

6. EC and EU declaration of conformity marking

6.1 The manufacturer affixes the CE marking and, under the responsibility of the notified body referred to in paragraph 3.1, the identification number of the latter in each pressure equipment that satisfies the applicable requirements of this royal decree.

6.2 The manufacturer shall draw up an EU declaration of conformity for each model of pressure equipment and keep it at the disposal of the national authorities for a period of ten years from the introduction of the pressure equipment on the market. The EU declaration of conformity computer model will identify pressure for which it has been developed and the number of the design examination certificate shall be given.


A copy of the EU declaration of conformity to the competent authorities be provided upon request.

7. Conservation documentation.

For a period of ten years from the introduction of the pressure equipment on the market, the manufacturer shall make available to the national authorities:

The documentation concerning the quality system referred to in paragraph 3.1.

The adaptation section 3.5 has been approved concerns.

Decisions and reports from the notified body referred to in paragraphs 3.5, 5.3 and 5.4.

8. Authorized representative.

The manufacturer's authorized representative may lodge the application referred to in paragraphs 4.1 and 4.2 and fulfill the obligations set out in paragraphs 3.1, 3.5, 4.4, 4.6, 6 and 7, on his behalf and under his responsibility , provided that they are specified in the mandate.
ANNEX IV


EU Declaration of Conformity (No. xxxx) 1

1. Pressure equipment or set (product number, type, batch or serial).

2. Name and address of the manufacturer and, where appropriate, of his authorized representative.

3. This declaration of conformity is issued under the sole responsibility of the manufacturer.

4. Object of the declaration (identification of the pressure equipment or assembly allowing traceability, if necessary for identification of the pressure equipment or assembly, you can include an image):

Description of the pressure equipment or assembly.

Procedure used for conformity assessment.

For assemblies, description of the pressure equipment constituting the assembly, and description of the procedure used for the conformity assessment.

5. The object of the declaration described above is in accordance with the legislation relevant Union harmonization.

6. References to the relevant harmonized standards used or references to the other technical specifications regarding which conformity is declared.

7. Where appropriate, the name, address and number of the notified body which carried out the conformity assessment and issued certificate number, and a reference to the EU examination certificate -type type of production, the EU examination certificate type- type of design, the certificate of EU design examination, or the certificate of conformity.

8. Additional Information.

Signed for and on behalf of:

(Place and date of issue):

(Name, position) (Signature):

(If applicable, identification authorized to sign the legally binding declaration for the manufacturer or his authorized representative signatory)

1. The manufacturer may assign an optional basis a number to the declaration of conformity.