The European Parliament and the Council adopted, on 29 May 1997, Directive 97 /23/EC on the approximation of the laws of the Member States relating to pressure equipment.

In compliance with the obligations arising from the Treaty of Accession of Spain to the European Communities, as well as the provisions of Article 20 of that Directive, it is necessary to lay down the national provisions governing and adapt the forecasts contained in the abovementioned directive to the Spanish situation.

Given the mandatory nature of this Royal Decree, it is necessary to repeal the provisions of the Pressure Equipment Regulation, approved by Royal Decree 1244/1979 of 4 April 1979, concerning the design, manufacture and evaluation of conformity, being in force for those equipment excluded or not covered by this Royal Decree and all those requirements which do not strictly relate to the three fields mentioned above.

According to the provisions of Article 24 (c) of Law 50/1997 of 27 November of the Government, this provision has been subject to the procedure of the hearing provided for by the Commission, referring to the Commission Adviser to Aparates to Pressure.

Under the proposal of the Minister of Industry and Energy, in agreement with the Council of State and after deliberation by the Council of Ministers at its meeting of 7 May 1999,

DISPONGO:

Article 1. Scope and definitions.

1. This Royal Decree applies to the design, manufacture and conformity assessment of pressure equipment and assemblies subject to a maximum permissible pressure PS exceeding 0,5 bar.

2. For the purposes of this Royal Decree, it is understood by:

2.1 "Pressure equipment", containers, pipes, security accessories and pressure accessories. Where appropriate, the elements attached to the pressure parts, such as flanges, tubers, couplings, clamps, supports, hoists for hoisting, etc., shall be deemed to be part of the pressure equipment.

2.1.1 "Receipt", a cover designed and manufactured to contain pressure fluids, including direct mounting elements up to the intended device for connection with other equipment. A container may consist of more than one chamber.

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

2.1.3 "Safety accessories" means devices intended for the protection of equipment under pressure from the overshoot of the permissible limits. These devices may be:

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

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

2.1.4 "Pressure Accessories" means devices for operating purposes whose cover is under pressure.

2.1.5 "Sets", several pressure equipment assembled by a manufacturer in such a way as to constitute a functional installation.

2.2 "Pressure", the pressure relative to the atmospheric pressure, i.e. the manometric pressure. Consequently, the vacuum is expressed by a negative value.

2.3 "Maximum permissible pressure PS", the maximum pressure for which the equipment is designed, specified by the manufacturer.

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

2.4 "Maximum/minimum permissible temperature TS", the maximum and minimum temperatures for which the equipment is designed, specified by the manufacturer.

2.5 "Volume V" means the internal volume of a camera, including the volume of the tubers to the first connection or welding and excluding the volume of the permanent internal elements.

2.6 "Nominal diameter DN", a figure of identification of the diameter common to all the elements of a pipe system, except for the elements indicated by its external diameters or by the size of the thread. It shall be a rounded number for reference purposes, without strict relation to the manufacturing dimensions. It will be called the letters DN followed by a number.

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

2.8 "Permanent Unions", unions that can only be separated by destructive methods.

2.9 "European Material Approval", a technical document defining the characteristics of materials intended for repeated use in the manufacture of pressure equipment, which are not subject to harmonised standards.

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

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

3.2 The networks for water supply, distribution and evacuation, as well as their equipment and water drives for hydroelectric installations and their specific accessories.

3.3 Equipment falling within the scope of Royal Decree 1495/1991 of 11 October 1991 laying down detailed rules for the application of Directive 87 /404/EEC on simple pressure vessels.

3.4 The teams included in Council Directive 75 /324/EEC of 20 May on the approximation of the laws of the Member States relating to aerosol dispensers, transposed by Royal Decree 2549/1994, December 29, by which the supplementary technical instruction MIE-AP 3 of the Regulation of pressure equipment, concerning aerosol dispensers, is amended.

3.5 Equipment for the operation of vehicles defined in the following Directives and their Annexes, transposed by Royal Decree 2028/1986 of 6 June.

70 /156/EEC, of the Council of 6 February, on the approximation of the laws of the Member States relating to the type-approval of motor vehicles and their trailers.

74 /150/EEC, of the Council of 4 March, on the approximation of the laws of the Member States relating to the type-approval of wheeled agricultural or forestry tractors.

92 /61/EEC of the Council of 30 June concerning the reception of two-or three-wheel motor vehicles.

3.6 Equipment corresponding to category I in accordance with the provisions of Article 9 of this Royal Decree and which are covered by one of the following Royal Decrees:

Royal Decree 1435/1992 of 27 November 1992 laying down detailed rules for the application of Council Directive 89 /392/EEC on machinery.

Royal Decree 1314/1997 of 1 August 1997 laying down detailed rules for the application of the Directive of the European Parliament and of the Council 95 /16/EC on lifts.

Royal Decree 7/1988 of 8 January laying down detailed rules for the application of Council Directive 73 /23/EEC on electrical equipment intended for use in certain voltage limits.

Royal Decree 414/1996 of 1 March 1996 laying down detailed rules for the application of Council Directive 93 /42/EEC on medical devices.

Royal Decree 1428/1992 of 27 November 1992 laying down detailed rules for the application of the Directive of the Council of the European Communities 90 /396/EEC on appliances for gas.

Royal Decree 400/1996 of 1 March 1996 laying down detailed rules for the application of the Directive of the European Parliament and of the Council 94 /9/EC on protective equipment and systems for use in atmospheres potentially explosive.

3.7 The equipment referred to in Article 223 (1) (b) of the Treaty establishing the European Community.

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

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

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

Engines, including turbines and internal combustion engines.

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

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

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

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

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

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

3.16 The exhaust and intake silencers.

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

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

3.19 The equipment covered by the ADR, RID, IMDG and ICAO conventions.

3.20 Radiators and tubes in hot water heating systems.

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

Article 2. Market surveillance.

1. Only pressure equipment and assemblies referred to in Article 1 may be placed on the market and put into service if they do not compromise the safety or health of persons or, where appropriate, domestic animals or property, where they are installed and properly maintained and used in accordance with the purpose for which they are intended.

2 The provisions of this Royal Decree shall be without prejudice to the rules existing in the Autonomous Communities and the power of the State Administration to ensure the protection of persons and, (a) in particular, of workers using the pressure equipment or the assemblies concerned, provided that this does not entail any amendments thereto in relation to this Royal Decree.

3. It shall be permitted, on the occasion of trade fairs, exhibitions or demonstrations, to present pressure equipment or assemblies as defined in Article 1, which are not in conformity with the provisions of this Royal Decree, provided that it is clearly stated, by a visible sign, their non-conformity, as well as the impossibility of acquiring such equipment before the manufacturer, or his authorised representative established in a Member State of the European Union, has made them conform. The demonstrations shall take, in accordance with the requirements laid down by the Autonomous Communities, appropriate security measures to ensure the protection of persons.

Article 3. Technical requirements.

1. The pressure equipment listed in paragraphs 1.1, 1.2, 1.3 and 1.4 shall comply with the essential requirements set out in Annex I:

1.1 The vessels, except those referred to in paragraph 1.2, provided for:

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

For fluids in Group 1, which have a volume of more than 1 litre and whose product PS ^ V is greater than 25 bar ^ litre, or those with a pressure PS of more than 200 bar (Table 1 of Annex II).

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

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

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

For group 2 fluids, those with a pressure PS greater than 10 bar and the product PS ^ V exceeding 10,000 bar ^ litre, as well as those with a pressure PS of more than 1,000 bar (Table 4 of Annex II).

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

1.3 Piping for:

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

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

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

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

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

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

1.4 Security accessories and pressure accessories for equipment referred to in paragraphs 1.1, 1.2 and 1.3, including when such equipment is incorporated into a package.

2. The assemblies defined in Article 1 (2.1.5) and listed in paragraphs 2.1, 2.2 and 2.3 of this paragraph which comprise at least one pressure equipment referred to in paragraph 1 of this Article shall comply with the requirements laid down in this Article. essential elements listed in Annex I.

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

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

2.3 By way of derogation from the introductory sentence of paragraph 2, the sets intended for the production of hot water with a temperature of 110 or less than 110 or C, fed manually with solid fuel, with a product PS x V exceeding 50 bar ^ litre, shall meet the essential requirements referred to in paragraphs 2.10, 2.11, 3.4 and paragraphs (a) and (d)

Annex I.

3. Pressure equipment and/or assemblies whose characteristics are less than or equal to the limits referred to in paragraphs 1.1, 1.2 and 1.3 and in paragraph 2 shall be designed and manufactured in accordance with the good (a) technical practices for use in a Member State of the European Union in order to ensure safety in their use. The pressure equipment and/or assemblies shall be attached to sufficient instructions for use and shall bear the appropriate markings to enable the manufacturer or his authorised representative established in the Community to be identified.

Such pressure equipment and/or assemblies shall not bear the CE marking as defined in Article 15.

Article 4. Free movement.

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

1.1 The placing on the market or putting into service, under the conditions laid down by the manufacturer, of the pressure equipment or assemblies referred to in Article 1, which comply with the provisions of this Royal Decree and which carry the 'EC' marking, which indicates that they have been subject to an assessment of conformity in accordance with Article 10.

1.2 The placing on the market or putting into service of pressure equipment or assemblies complying with the provisions of Article 3 (3).

2. To the extent necessary for the safe and correct use of pressure equipment and assemblies, it may be required that the information referred to in paragraphs 3.3 and 3.4 of Annex I be provided in Spanish or in the official language of the State. member in which the equipment is made available to the end user.

Article 5. Presumption of conformity.

1. Pressure equipment and assemblies bearing the CE marking provided for in Article 15 and the EC declaration of conformity set out in Annex VI shall be presumed to comply with all the provisions of this Royal Decree, including the assessment of the conformity referred to in Article 10.

2. Pressure equipment and assemblies conforming to the national rules of a Member State of the European Community shall be presumed to incorporate into national law harmonised standards for which references have been published in the Official Journal. of the European Communities ', comply with the essential requirements laid down in Article 3.

3. The Ministry of Industry and Energy shall publish, by means of a decision of the competent industrial safety management centre, the references of the harmonised standards referred to in the previous paragraph, as well as the UUNE rules to be transposed, updating them in the same way.

4. It will ensure that appropriate measures are taken to enable the social partners to influence, at national level, the process of drawing up and monitoring harmonised standards.

Article 6. Committee on technical standards and regulations.

Where it is considered that the rules referred to in Article 5 (2) do not fully meet the essential requirements laid down in Article 3, the General Administration of the State or the Commission of the European Union The Committee shall draw up the Standing Committee set up by Article 5 of Directive 83 /189/EEC of 28 March.

These rules shall be withdrawn if the Commission or the General Administration of the State so considers, in the light of the opinion of that Committee.

Article 7. Breaches of security conditions.

When considered, for very serious security reasons:

A pressure equipment or a family of equipment under pressure from those referred to in Article 3 (3) must be subject to the provisions of Article 3 (1), or that:

A set or a family of sets of those referred to in Article 3 (3) must be subject to the provisions of Article 3 (2), or that:

A pressure equipment or family of pressure equipment must be classified, by way of derogation from Annex II, in another category, it shall be made, duly documented, in the knowledge of the competent industrial safety authority of the Ministry of Industry and Energy to be transferred to the Commission of the European Communities in order to take appropriate action.

Article 8. Safeguard clause.

1. Where it is found that pressure equipment or assemblies referred to in Article 1 bearing the CE marking and which are used in accordance with their intended purpose may endanger the safety of persons and, where appropriate, domestic animals or of the goods, all necessary measures shall be taken to remove such equipment from the market, prohibit its placing on the market, its putting into service or restrict its free movement.

The General Administration of the State shall immediately inform the European Commission of such measures and shall indicate the reasons for its decision, in particular if the non-compliance is derived:

(a) Failure to comply with the essential requirements referred to in Article 3.

(b) A bad application of the rules referred to in Article 5 (2).

(c) Loopholes in the own rules referred to in Article 5 (2).

(d) Gaps in the European approval of materials for pressure equipment as referred to in Article 11.

2. Where a pressure equipment or set does not comply with the CE marking, the competent authority shall take the necessary measures against the person who has affixed the CE marking and the State Administration shall inform the Union Commission thereof. European and the other Member States.

Article 9. Classification of the pressure equipment.

1. The pressure equipment referred to in Article 3 (1) shall be classified by category in accordance with Annex II, depending on the increasing degree of danger.

For the purposes of this classification, fluids shall be divided into two groups in accordance with paragraphs 2.1 and 2.2.

2.1 In group 1, hazardous fluids are included.

Dangerous fluid means a substance or a preparation in accordance with the definitions in Article 2 (2) of Council Directive 67 /548/EEC of 27 June on the approximation of laws, regulations and administrative provisions, Regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances transposed by Royal Decree 2216/1985 of 25 October.

Group 1 includes fluids defined as:

Explosives.

Extremely flammable.

Easily flammable.

Flammable (when the maximum permissible temperature is at a temperature above the flash point).

Very toxic.

Toxic.

Comburents.

2.2 In group 2 all other fluids not referred to in paragraph 2.1 are included.

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

Article 10. Assessment of conformity.

1.1 Before placing a pressure equipment on the market, the manufacturer must submit it to one of the conformity assessment procedures described in Annex III and under the conditions laid down in this Article.

1.2 The conformity assessment procedures to be applied for the affixing of the CE marking to a pressure equipment shall be determined by the category, established in accordance with Article 9, in which the equipment is classified.

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

Category I:

Module A.

Category II:

Module A1.

Module D1.

Module E1.

Category III:

B1 + D. Module

Module B1 + F.

ModuloB + E.

ModuloB + C1.

H. Module

Category IV:

ModuloB + D.

ModuloB + F.

G. Module

Module H1.

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

1.5 In the framework of the quality assurance procedure for equipment classified in categories III and IV, referred to in paragraph 1.1 (a), in the first subparagraph of paragraph 1.1 (b) and in the Article 3 (1.2), the notified body, when making unannounced visits, shall take a sample of the equipment at the manufacturing or storage site for the purpose of carrying out, or carrying out, the final verification referred to in the paragraph 3.2.2 of Annex I. To this end, the manufacturer shall inform the notified body of the planned plan of production. The notified body shall carry out at least two visits during the first year of manufacture. The notified body shall fix the frequency of subsequent visits in accordance with the criteria set out in paragraph 4.4 of the relevant modules.

1.6 In the case of the manufacture of a single specimen of containers and equipment classified in category III, referred to in Article 3 (2) in accordance with the procedure of module H, the notified body shall carry out or shall ensure that the final verification, as referred to in paragraph 3.2.2 of Annex I, of each unit is carried out. To this end, the manufacturer shall communicate the planned production plan to the notified body.

2. The assemblies referred to in Article 3 (2) shall be subject to a general conformity assessment procedure which shall include:

(a) The assessment of each of the pressure equipment forming part of the assembly and referred to in Article 3 (1), where they have not previously been subjected to a conformity procedure and a marking 'EC' separately; the assessment procedure shall be determined by the category of each of the teams.

(b) The assessment of the integration of the different elements of the set, in accordance with paragraphs 2.3, 2.8 and 2.9 of Annex I, which shall be determined by the highest category of the equipment concerned, not having a Security equipment is available for this purpose.

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

3. By way of derogation from paragraphs 1 and 2, the competent authorities may, where justified, permit the placing on the market and putting into service on the national territory of the pressure equipment and individual assemblies referred to in that paragraph. Article 1 (2), for which the procedures laid down in paragraph 1y2 of this Article have not been applied and whose use is of interest to experimentation.

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

Article 11. European approval of materials.

1. At the request of one or more manufacturers of materials or equipment, one of the notified bodies referred to in Article 12, specifically designated for that function, shall issue the European approval of materials, as defined in the paragraph 2.9 of Article 1. The notified body shall define and carry out, or have carried out, the appropriate examinations and tests to certify the conformity of the types of material with the corresponding requirements of this Royal Decree. In the case of recognised safe use materials before 29 November 1999, the notified body shall take into account the existing data to certify that conformity.

2. Before issuing the European material approval, the notified body shall inform the Member States and the Commission of the relevant elements. Within a period of three months, any Member State or the Commission may use the Standing Committee set up by Article 5 of Directive 83 /189/EEC of 28 March laying down its reasons. In the latter case, the Committee shall deliver an urgent opinion.

The notified body shall issue the European approval of materials taking into account, where appropriate, the opinion of that Committee and the comments submitted.

3. A copy of the European approval of materials for pressure equipment shall be transmitted to the Member States, the notified bodies and the Commission.

The Commission will publish and keep up to date a list of European material approvals in the Official Journal of the European Communities.

4. Where the materials used in the manufacture of pressure equipment are in conformity with the European materials approvals and their references have been published in the Official Journal of the European Communities, they shall be presumed to be in conformity with the the essential requirements applicable to them in accordance with Annex I.

5. The notified body which has issued the European approval of materials for pressure equipment shall withdraw such approval when it finds that it should not have been issued or when the type of material is covered by a harmonised standard. It shall immediately inform the other Member States, the notified bodies and the Commission of any withdrawal of approval.

6. The Ministry of Industry and Energy shall publish, by means of a decision of the competent industrial safety management centre, the list of European material approvals referred to in paragraph 3 by updating them the same form, periodically.

Article 12. Notified bodies.

1. The Spanish notified bodies responsible for carrying out the certification procedures referred to in Articles 10 and 11 shall have the status of control bodies referred to in Chapter I, Title III of Law 21/1992, of July 16, Industry, developed in Chapter IV of the Regulation of the Infrastructure for Quality and Industrial Safety, approved by Royal Decree 2200/1995, of December 28, and must, in any case, meet the minimum criteria set out in Annex IV to this Royal Decree.

The control bodies which satisfy the assessment criteria laid down in the relevant harmonised standards shall be presumed to comply with the criteria set out in Annex IV.

2. The Autonomous Communities shall send to the Ministry of Industry and Energy a copy of the authorization granted to the control bodies which have requested to be notified, expressly indicating the tasks for which they have been appointed, effects of its dissemination and eventual communication to the other competent authorities, as well as to the European Commission and the other Member States, subject to the allocation of the corresponding identification numbers by the Commission European.

3. The Spanish notified bodies shall be regularly inspected, in accordance with the provisions of Royal Decree 2200/1995, cited above, for the purpose of verifying that they faithfully fulfil their duties in relation to the application of this Royal Decree.

Where, by means of a negative report by an accreditation entity, or by other means, it is established that a Spanish notified body no longer meets the criteria set out in paragraph 1, the authorisation shall be withdrawn. The Ministry of Industry and Energy, through the Ministry of Foreign Affairs, shall immediately inform the other Member States and the European Commission, for the purpose of cancelling the notification.

4. Where a Spanish notified body decides to refuse or withdraw a certificate from a team or assembly falling within the scope of this Royal Decree, it shall proceed as laid down in Article 16 of Law 21/1992 of 16 July 1992. Industry.

The Industry and Industry Administration which has intervened in the above procedure shall inform the Ministry of Industry and Energy of any decision confirming that of the notified body.

5. The Ministry of Industry shall publish, by means of a decision of the competent industrial safety management centre, for information, the list of bodies notified by the Member States of the European Union, indicating their numbers. identification and the tasks for which they have been notified.

Article 13. Recognised independent entities.

1. The recognised Spanish independent entities responsible for carrying out the tasks referred to in paragraphs 3.1.2 and 3.1.3 of Annex I shall comply with the conditions of the control bodies referred to in Chapter I, Title III of the Law. 21/1992, cited in the previous article, developed in Chapter IV of the Regulation of the Infrastructure for Quality and Industrial Safety, also referred to in the previous article, and must, in any case, meet the minimum criteria set out in Annex IV to the Royal Decree.

Independent entities that satisfy the assessment criteria laid down in the relevant harmonised standards shall be presumed to comply with the criteria set out in Annex IV.

2. The Autonomous Communities shall send to the Ministry of Industry and Energy copies of the authorization granted to the independent entities which have requested to be notified, expressly indicating the tasks for which they have been appointed, effects of its dissemination and eventual communication to the other competent authorities, as well as to the other Member States.

3. The recognised Spanish independent entities shall be inspected on a regular basis, in accordance with the provisions of Royal Decree 2200/1995, for the purpose of verifying that they fulfil their duties faithfully in relation to the application of the Royal Decree.

When, by means of a negative report by an accreditation entity, or by other means, it is established that a recognised Spanish independent entity no longer meets the criteria set out in paragraph 1, the following shall be withdrawn: authorisation. The Ministry of Industry and Energy, through the Ministry of Foreign Affairs, shall immediately inform the other Member States and the European Commission thereof, for the purpose of cancelling the notification.

4. Where a recognised Spanish independent entity decides to refuse or withdraw an approval, it shall proceed as set out in Article 16 of Law 21/1992 of 16 July of Industry. The competent authority in the field of industry which has intervened in the preceding procedure shall communicate to the Ministry of Industry any decision confirming that of the recognised independent entity.

5. The Ministry of Industry and Energy shall publish, by means of a decision of the competent industrial safety management centre, for information, the list of independent entities recognised by the Member States of the European Union. with an indication of the tasks for which they have been recognised.

Article 14. CE marking.

1. The CE marking shall be made up of the initials 'CE', the logo of which appears in Annex V.

The CE marking shall be accompanied by the identification number referred to in Article 12 (2) of the notified body involved in the production control phase.

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

For each pressure equipment referred to in Article 3 (1), or for each set referred to in Article 3 (2), either whole or in a state that permits final verification, as described in paragraph 3.2 of the Annex I.

3. The marking 'EC' shall not be required for each individual pressure equipment which consists of a set of the conditions referred to in Article 3 (2). Individual pressure equipment which already bears the CE marking when incorporated into the assembly shall be retained.

4. Where the pressure equipment or assembly is subject to other provisions applying other Community Directives relating to other aspects which provide for the affixing of the CE marking, the latter shall indicate the presumption of conformity of the equipment to pressure or in conjunction with the provisions implementing those other Directives.

However, in the event that one or more of those provisions allow the manufacturer during a transitional period the choice of the scheme to be applied, the CE marking shall only indicate conformity with the provisions which apply the Directives used by the manufacturer. In that case, the references to those provisions, as published in the "Official Gazette of the State", shall be contained in the documents, leaflets or instructions required by those provisions accompanying the pressure and pressure equipment. set.

5. It shall be prohibited to fix in the pressure equipment and in the marked assemblies that they may mislead third parties about the meaning or the logo of the CE marking. Any other marking may be affixed to pressure equipment or assemblies provided that the visibility and legibility of the CE marking is not reduced.

Article 15. Improper placement of the CE marking.

Without prejudice to the provisions of Article 8:

(a) Where it is established that the CE marking has been affixed unduly, the manufacturer, or his authorised representative established in the European Union, shall have the obligation to make the product conform to the provisions on the marking 'EC' and an end to such an infringement under the conditions laid down by the legislation in force.

(b) If the non-compliance persists, the corresponding Autonomous Community shall take all necessary measures to restrict or prohibit the placing on the market of the product concerned or to ensure that it is withdrawn from the market in accordance with the with the procedures laid down in Article 8.

Article 16. Decision of refusal or restriction.

Any decision to be taken pursuant to this Royal Decree and which therefore has the effect of restricting the placing on the market and putting into service or imposing the withdrawal of the market from a pressure equipment or assembly must be clearly motivated.

The decision will be notified as soon as possible to the person concerned, indicating the means of appeal offered by the current legislation and the time limits for the presentation of the resources.

Article 17. Infringements and sanctions.

The violations of this Royal Decree will be sanctioned in accordance with the provisions of Title V of Law 21/1992, of July 16, of Industry.

Additional disposition first. Applicable regulations.

Pressure equipment and assemblies whose putting into service would have been carried out prior to the entry into force of this Royal Decree shall continue to be governed by the technical requirements of the Regulation which has been application.

Additional provision second. Putting into service.

For the putting into service of pressure equipment and assemblies of this Royal Decree, the procedures laid down for the purpose in the Regulation of pressure equipment and its technical instructions shall be followed. complementary.

Single transient arrangement. Transitional period.

Pressure equipment and assemblies complying with the provisions of the Regulations on Pressure Equipment may continue to be placed on the market and put into service until 29 May 2002, as well as the putting into service of such pressure equipment and assemblies after that date has been exceeded.

Single repeal provision. Regulatory repeal.

As of May 29, 2002, the Regulation of Pressure Equipment, approved by Royal Decree 1244/1979 of 4 April 1979, is repealed, in all matters relating to the design, manufacture and conformity assessment of equipment to pressure and the assemblies included in the scope of this Royal Decree, remaining in force in their entirety for the excluded and not contemplated in it.

Final disposition first. Powers of development.

The Minister of Industry and Energy is hereby authorized to lay down the rules for the development of this Royal Decree.

Final disposition second. Entry into force.

This Royal Decree will enter into force on 29 November 1999.

Given in Madrid to 7 May 1999.

JOHN CARLOS R.

The Minister of Industry and Energy,

JOSEP PIQUE I CAMPS

ANNEX I

ESSENTIAL SECURITY REQUIREMENTS

Preliminary Observations

1. The obligations laid down in the essential requirements set out in this Annex in respect of pressure equipment are also applicable to assemblies where there is a corresponding risk.

2. The essential requirements set out in this Royal Decree are mandatory. The obligations laid down in those essential requirements shall apply only where the pressure equipment concerned bears the relevant risk when used under the reasonably foreseeable conditions on the part of the manufacturer.

3. The manufacturer shall have an obligation to analyse the risks in order to define those which apply to his equipment because of the pressure and, subsequently, he must design and manufacture them taking into account his analysis.

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

1. Generalities

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

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

Remove or reduce risks as much as reasonably possible.

Apply appropriate protection measures against risks that cannot be removed.

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

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

2. Design

2.1 Generalities:

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

The design shall include appropriate safety coefficients which shall be based on general methods which are deemed to use relevant safety margins to prevent in a consistent manner all types of failures.

2.2 Design for appropriate resistance:

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

The outside pressure and the inside pressure.

The room temperature and service temperature.

The static pressure and the mass of the substance contained in operating and test conditions.

Loads due to traffic, wind and earthquakes.

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

Corrosion and erosion, fatigue, etc.

Decomposition of unstable fluids.

The different loads that may be present at the same time should be considered taking into account the probability of their simultaneous event.

2.2.2 Design for appropriate resistance should be based on:

As a general rule, a calculation method, as specified in paragraph 2.2.3 completed, if necessary, with an experimental design method as specified in paragraph 2.2.4, or an experimental method of design without calculation, as specified in paragraph 2.2.4, in the case where the product of the maximum permissible pressure PS by volume V is less than 6,000 bar x l, or the product PS x DN is less than 3,000 bar.

2.2.3 Method of calculation:

a) Containment of pressure and other charges:

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

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

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

Layout by formulas.

Design by analysis.

Design by mechanics of breakage.

b) Resistance:

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

In particular:

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

Calculation temperatures should allow for adequate safety margins.

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

Maximum tensions and concentrations of maximum voltage values should be maintained within safe limits.

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

The characteristics of the materials to be considered shall include, where appropriate:

The elastic limit, at 0.2 or 1.0 per 100 of the test voltage, as the case may be, at the calculation temperature, as indicated in paragraph 7.1.1.

The tensile strength.

The resistance to the yield deferred in time.

The fatigue resistance.

The Young module (longitudinal elasticity module).

The allowable plastic deformation value.

Impact resistance (resilience).

Toughness to fracture.

Should be applied to the characteristics of the materials coefficients of resistance of the appropriate joints in function, for example, of the character of the non-destructive tests, of the properties of the joints of materials and of the intended operating conditions (as referred to in paragraph 7.2).

The design shall take due account of all reasonably foreseeable degradation processes (in particular corrosion, fluency and fatigue), corresponding to the use of the equipment.

The instructions referred to in paragraph 3.4 should draw attention to the design characteristics that are decisive for the life of the team, such as:

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

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

For corrosion: the tolerance of theoretical corrosion.

c) Stability:

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

2.2.4 Experimental Method of Design:

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

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

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

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

The test program must include:

(a) A pressure resistance test to verify whether, at a pressure ensuring a defined safety margin with respect to the maximum permissible pressure, the equipment does not present significant leakage or deformation of more than one limit.

The test pressure shall be determined taking into account the differences between the values of the geometrical characteristics and the measured materials in the test conditions and the values allowed for the design; must take into account the difference between test and design temperatures.

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

(c) Where necessary, additional evidence on other specific external factors referred to in paragraph 2.2.1, such as corrosion, external actions, etc.

2.3 Provisions to ensure safe use and operation:

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

To openings and closures.

To the dangerous discharges of the safety valves.

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

At the surface temperature, taking into account the intended use.

To the breakdown of unstable fluids.

In particular, pressure equipment equipped with a visiting door must be fitted with an automatic or manual device that allows the user to easily ensure that the opening does not pose any danger. In addition, when such opening can be operated quickly, the pressure equipment must be equipped with a device to prevent the opening when the pressure or temperature of the fluid is in danger.

2.4 Inspection media:

(a) The pressure equipment must be designed in such a way as to enable all necessary safety inspections to be carried out.

(b) Means shall be provided for determining the internal state of the pressure equipment where necessary to ensure the permanent security of the equipment, such as to allow physical access to the interior of the equipment for power carry out appropriate inspections in a safe and ergonomic manner.

c) Other means may be used to ensure that the pressure equipment meets all safety requirements when:

Be too small to physically access your interior.

The opening of the pressure equipment may adversely affect the interior.

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

2.5 Purge and vent systems:

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

Avoid pernicious effects, such as battering ram, vacuum-triggered collapse, corrosion, and uncontrolled chemical reactions. All phases of operation and testing, in particular pressure testing, shall be taken into account.

Allow cleaning, control, and maintenance safely.

2.6 Corrosion and other chemical actions:

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

2.7 Unspend:

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

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

Allow replacement of the most affected parts.

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

2.8 Sets:

Sets will be designed so that:

The elements that you are going to join are suitable and reliable for your service.

All elements are properly integrated and properly joined.

2.9 Fill and flush provisions:

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

a) In the filling:

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

The instability of the pressure equipment.

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

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

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

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

The appropriate device or the combination of suitable devices shall be determined according to the characteristics of the equipment or the assembly and its operating conditions.

Protection devices and combinations of these devices will include:

(a) The security accessories as defined in Article 1 (2) (1).

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

2.11 Security Accessories:

2.11.1 Security accessories must:

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

Be independent of the other functions, unless they can affect your security function.

Respond to the right design principles to achieve tailored and reliable protection. These principles will include in particular dual security, redundancy, diversity and self-control.

2.11.2 Pressure Limiting Organs:

These organs must be designed so that the pressure does not permanently exceed the maximum permissible pressure PS; however, a short increase in the pressure shall be permitted where appropriate, according to the provided for in paragraph 7.3.

2.11.3 Temperature Control Devices:

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

2.12 Exterior Fire:

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

3. Manufacturing

3.1 Manufacturing procedures:

The manufacturer shall ensure the correct execution of the provisions laid down in the design stage by applying the appropriate techniques and methods, in particular as regards the following aspects:

3.1.1 Preparing the components:

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

3.1.2 Permanent Unions:

Permanent junctions of adjacent materials and areas (ZAT) shall be exempt from surface or interior deficiencies that are detrimental to the safety of equipment.

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

For pressure equipment, the permanent joints of the elements that contribute to the resistance of the equipment to the pressure and the elements that are directly integrated must be carried out by qualified personnel with the appropriate level of competence and through qualified procedures.

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

A notified body.

An independent entity recognised by a Member State as set out in Article 13.

In order to proceed with such approvals, the independent body shall perform or cause the examinations and tests provided for in the appropriate harmonised standards or equivalent tests and tests to be carried out.

3.1.3 Non-destructive tests:

For pressure equipment, non-destructive controls of permanent joints must be performed by qualified personnel with the appropriate level of competence. For pressure equipment of categories III and IV, such staff shall have been approved by an independent entity recognised by a Member State pursuant to Article 13.

3.1.4 Thermal treatment:

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

3.1.5 Knowledge of the characteristics of the materials:

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

3.2 Final Verification:

The pressure equipment must be subjected to the final verification described below.

3.2.1 Final Inspection:

The pressure equipment must be subjected to a final inspection to visually check the compliance with the requirements of this Royal Decree by checking the accompanying documents.

In this case, the controls that have been carried out during the manufacture may be taken into account. In so far as the safety techniques so require, the final inspection shall be carried out on the inside and outside on all parts of the equipment or assembly and, where appropriate, in the course of the manufacturing process (for example, when no longer verification is possible during the final inspection.)

3.2.2 Test:

The final verification of the pressure equipment shall include a pressure resistance test which is normally performed in the form of a hydrostatic pressure test at a pressure at least equal to, where applicable, the value of the pressure equipment. set out in paragraph 7.4.

For category I equipment manufactured in series, this test may be carried out by statistical means.

In cases where the hydrostatic pressure test is harmful or unfeasible, other recognized value tests may be performed. Additional measures, such as non-destructive controls or other methods of equivalent efficacy, shall be applied for tests other than the hydrostatic pressure test.

3.2.3 Review of security devices:

For sets, the final verification shall also include an examination of the safety devices to verify whether the requirements referred to in paragraph 2.10 have been complied with.

3.3 Brands and tagging:

In addition to the CE marking referred to in Article 15, the following information shall be provided:

a) For all pressure equipment:

Name, surname and address and other details of the manufacturer's identification and, where appropriate, his authorised representative established in the Community.

Year of manufacture.

Identification of the pressure equipment, such as the type, the identification of the series or the batch, and the manufacturing number.

Maximum and minimum essential limits admissible.

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

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

The nominal diameter of the pipes (DN).

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

The break pressure of the safety device, expressed in bar.

The power of the pressure equipment, expressed in kW.

The power voltage, expressed in volts (V).

The intended use.

The degree of filling, expressed in kg/l.

The maximum filling mass, expressed in kg.

The tarada mass, expressed in kg.

The product group.

(c) Where appropriate, the warnings set out in the pressure equipment shall draw attention to the use errors demonstrated by the experience.

The CE marking and the required information shall be placed on the pressure equipment or on a bell plate solidly attached to it, except in the following cases:

Where appropriate, an appropriate document may be used to prevent the repetition of the marking on individual elements as components of pipes, intended for the same set. The same shall apply to the CE marking and to other markings and markings referred to in this Annex.

When the pressure equipment is too small, for example, with the accessories, the information referred to in paragraph (b) may appear on a label attached to the pressure equipment.

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

3.4 Operating Instructions:

(a) Where a pressure equipment is placed on the market, instructions for the user containing all the information useful for safety as regards:

shall be attached to the pressure equipment as necessary.

The assembly, including the joining of the various pressure equipment.

The putting into service.

The usage.

Maintenance, including user controls.

(b) The instructions shall include the information indicated in the pressure equipment in accordance with paragraph 3.3, with the exception of the identification of the series, and shall be accompanied, where appropriate, by the technical and/or technical documentation. the plans and schemes necessary for their correct understanding.

(c) Where appropriate, the instructions shall also make note of the dangers of a misuse in accordance with paragraph 1.3 and the special characteristics of the design in accordance with paragraph 2.2.3.

4. Materials

The materials used for the manufacture of the pressure equipment must be suitable for application during the intended life of the latter, unless their replacement is provided for.

Welding materials and other bonding materials shall only comply in appropriate manner with the corresponding obligations of paragraph 4.1; paragraph 4.2 (a) and the first subparagraph of paragraph 4.3. individually as once united.

4.1 Materials for parts under pressure:

(a) They must have characteristics appropriate to the set of reasonably foreseeable operating conditions and test conditions, and in particular must have sufficient ductility and hardness. Where appropriate, the characteristics of these materials shall comply with the requirements of paragraph 7.5. In addition, a suitable selection of materials should be carried out to prevent, if necessary, fragile breakage; when, for specific reasons, fragile materials are to be used, appropriate measures shall be taken.

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

c) They should not be significantly sensitive to aging.

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

e) They must be chosen in such a way as to avoid significant negative effects when different materials are joined.

4.2

(a) The manufacturer of the pressure equipment must adequately define the values necessary for the design calculations referred to in paragraph 2.2.3, as well as the essential characteristics of the materials and their application; referred to in paragraph 4.1.

(b) The manufacturer shall include in the technical documentation the data relating to compliance with the provisions of this Royal Decree relating to materials, in any of the following ways:

By using materials according to harmonised standards.

By using materials that have received a European approval of materials for pressure equipment in accordance with Article 11.

Through a specific assessment of the materials.

(c) For equipment under pressure in categories III and IV, the specific assessment referred to in the third indent of subparagraph (b) shall be carried out by the notified body responsible for the procedures for the assessment of the conformity of the pressure equipment.

4.3 The equipment manufacturer shall take appropriate measures to ensure that the material used complies with the specifications required. In particular, documents produced by the manufacturer of the material in which conformity with a specified specification is certified shall be obtained for all material.

For the main parts under pressure of the categories II, III and IV equipment, the certificate must be a specific certificate of control of the product.

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

Specific requirements for certain pressure equipment:

In addition to the requirements set out in paragraph 1 (4), the following requirements shall apply to the pressure equipment referred to in Sections 5 and 6.

5. Pressure equipment which is subjected to the action of the flame or to a heat input which represents a danger of overheating, as referred to in Article 3 (1)

This category of pressure equipment will comprise:

The steam and hot water generators referred to in Article 3 (2), such as hot water and steam boilers with a home, steam reheating and water heaters, boilers of water, water boilers and water boilers. heat recovery, waste incineration boilers, immersion boilers heated by electricity or by electrodes, pressure cookers, and their accessories and, where appropriate, the water treatment systems for food and water Fuel supply and equipment for thermal flows other than water generators hot or steam, referred to in Article 3 (1.1), such as heaters for chemical processes and other similar processes, pressurised equipment for the preparation of food.

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

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

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

(c) The provisions necessary to eliminate the risks of damage arising from deposits and inlays shall be adopted.

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

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

6. Pipes as defined in Article 3 (1.3) Design and manufacture shall ensure that:

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

(b) Where there is a possibility of condensation of gaseous fluids inside the tubes, the means necessary to purge and expel the deposits and the inlays of the funds and costs shall be available for the purpose of prevent damage due to the battering or corrosion.

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

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

e) When the pipes contain fluids in group 1, adequate means are available for the incommunication of the intake ducts which present significant risks due to their size.

f) The hazard of accidental discharge is reduced to the maximum; the intakes shall be visibly marked on the permanent part in which the contents of the fluid contained.

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

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

This section forms an integral part of Annex I. The provisions laid down in this Section supplement the essential requirements of sections1a6for pressure equipment to which they apply.

7.1 Eligible Tensions:

7.1.1 Symbols:

Re/t, elastic limit, designates the value at the calculation temperature, depending on the cases:

The upper limit of yield for materials with lower and higher yield limits.

From the voltage to 1.0 per 100 of the total extension, for the austenitic steel and the unalloyed aluminum.

From voltage to 0.2 per 100 of permanent deformation, in other cases.

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

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

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

In the case of ferritic steel, including standard steel (rolled steel) and excluding fine-grained steels and steels that have undergone a special heat treatment, 2/3 of Re/t and 5/12 of Rm/20.

In the case of austenitic steel.

If your elongation after breakage is greater than 30 per 100, 2/3 of Re/t.

O, alternatively, and if its elongation after breakage is greater than 35 per 100, 5/6 of Re/t and 1/3 of Rm/t.

In the case of cast steel, non-alloy or low alloy, 10/19 of Re/t and 1/3 of Rm/20.

In the case of aluminum, 2/3 of Re/t.

In the case of aluminium alloys, which cannot be temperate, 2/3 of Re/t and 5/12 of Rm/20.

7.2 Coefficient joints:

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

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

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

For equipment that is not subject to non-destructive controls other than eye inspection: 0,7.

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

7.3 Pressure-limiting organs, mainly intended for pressure vessels:

The momentary pressure increase referred to in paragraph 2.11.2 shall be limited to 10 per 100 of the maximum permissible pressure.

7.4 Hydrostatic Test Pressure:

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

The pressure corresponding to the maximum load which the equipment may bear, having regard to its maximum permissible pressure and its maximum permissible temperature, multiplied by the coefficient 1,25, or the maximum pressure Permissible multiplied by the coefficient 1,43.

7.5. Characteristics of the materials:

Unless different values are not required according to different criteria to be taken into consideration, steel shall be considered to be sufficiently ductility, in accordance with paragraph 4.1 (a), when its elongation after the break in a traction test carried out in accordance with a standard procedure is at least equal to 14 per 100 and when its impact bending energy on ISO V test is at least equal to 27 J at a temperature not more than 20 or C but not more than the lowest operating temperature envisaged.

ANNEX II

Compliance Assessment Tables

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

II I = module A.

I II = modules A1, D1, E1.

III = modules B1 + D, B1 + F, B + E, B + C1, H.

IV = modules B + D, B + F, G, H1.

2. The safety fittings as defined in Article 1 (2) (1) and referred to in Article 3 (4) shall be classified in category IV.

However, as an exception, safety fittings manufactured for specific equipment may be classified in the same category as the equipment to be protected.

3. The pressure fittings as defined in Article 1 (2.1.4) and referred to in Article 3 (4) shall be classified according to the following:

Your maximum allowable pressure PS.

From your own volume of the Nominal DN, depending on the cases, and the group of fluids to which they are intended.

And the corresponding table for the containers or pipes shall be applied in order to specify the category of conformity assessment.

In cases where both the volume and the nominal diameter appropriate for the purposes of the application of the second indent are considered, the pressure fitting shall be classified in the highest category.

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

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Table 1. Vessels referred to in the first subparagraph of Article 3 (1) (a) By way of derogation, containers intended to contain an unstable gas and which should fall within the categories Y or II in application of Table 1 shall be to be classified in category III.

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Table 2. Recients referred to in the second subparagraph of Article 3

1.1) (a)

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

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Table 3. Containers referred to in the first subparagraph of Article 3

1) (b)

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Table 4. Vessels referred to in the second subparagraph of Article 3 (1) (b).

By way of derogation, the sets provided for the production of hot water referred to in Article 3 (2.3) shall be the object of a design study (module B1) in order to verify their conformity with the requirements essential requirements referred to in paragraphs 2.10, 2.11, 3.4 and paragraphs (a) and (d) of Annex I, paragraph 5, or a total quality assurance system (module H).

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Table 5. Pressure equipment referred to in Article 3 (2)

As an exception, pressure cookers shall be subject to a design control in accordance with a verification procedure that corresponds to at least one category III module.

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Table 6. Pipes referred to in the first subparagraph of Article 3

1) (a)

By way of derogation, pipes intended for unstable gases, which should fall within the categories of Table 6, should be classified in category III.

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Table 7. Pipelines referred to in the second subparagraph of Article 3 (3) (a)

By way of derogation, all pipes containing fluids at a temperature greater than 350 or C and which should fall within category II in application of Table 7 shall be classified in category III.

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Table 8. Pipelines referred to in the first subparagraph of Article 3 (3) (b)

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Table 9. Pipelines referred to in the second subparagraph of Article 3 (3) (b)

ANNEX III

Compliance assessment procedures

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

Module A (internal manufacturing control):

1. This module describes the procedure by which the manufacturer, or his authorised representative established in the Community, who fulfils the obligations laid down in paragraph 2, ensures and declares that the pressure equipment in question meets the requirements of the of this Royal Decree that apply to you. The manufacturer, or his authorised representative established within the Community, shall affix the CE marking to each unit of pressure equipment and draw up a written declaration of conformity.

2. The manufacturer shall draw up the technical documentation described in paragraph 3. The manufacturer, or his authorised representative established in the Community, shall keep it at the disposal of the national authorities for inspection purposes for 10 years. years from the date of manufacture of the last pressure equipment.

Where neither the manufacturer nor his representative is established in the Community, the obligation to keep the technical documentation available shall be the responsibility of the person placing the pressure equipment on the Community market.

3. The technical documentation shall allow the assessment of the conformity of the equipment under pressure with the requirements of this Royal Decree that apply to it. To the extent necessary for such assessment, it shall reflect the design, manufacture and operation of the pressure equipment and shall include:

A general description of the pressure equipment.

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

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

A list of the rules provided for in Article 5, applied in whole or in part, and the description of the solutions adopted to meet the essential requirements of this Royal Decree, where the rules have not been applied provided for in Article 5.

The results of the design calculations, the controls performed, and so on.

The test reports.

4. The manufacturer, or his authorised representative established within the Community, shall keep, together with the technical documentation, a copy of the declaration of conformity.

5. The manufacturer shall take all necessary measures to ensure that the manufacturing process ensures the conformity of the equipment under pressure manufactured with the technical documentation provided for in paragraph 2and with the requirements of this Royal Decree which are applicable.

Module A1 (internal control of manufacturing with final verification monitoring):

In addition to module A requirements, the following provisions apply:

The final verification shall be subject to surveillance in the form of unannounced visits by a notified body chosen by the manufacturer.

During such visits, the notified body must:

Establish that the manufacturer effectively performs the final verification in accordance with Section 3.2 of Annex I.

Make sampling at the manufacturing or storage site of the pressure equipment for control purposes. The notified body shall determine the number of units of equipment to be sampled, as well as the need to carry out or make the final verification on the sample pressure equipment fully or partially carried out.

If one or more pressure equipment is not in conformity, the notified body shall take appropriate action.

The manufacturer shall, under the responsibility of the notified body, fix the latter's identification number on each pressure equipment.

Module B (EC type examination):

1. This module describes the part of the procedure by which a notified body checks and certifies that a representative of the production in question meets the requirements of this Royal Decree which apply to it.

2. The manufacturer, or his authorised representative established in the Community, shall submit the application for the 'EC type' examination to a single notified body which he chooses.

The request will include:

The name, surname and address of the manufacturer and, if the application is submitted by a representative established in the Community, also the name, last name and address of the latter.

A written declaration specifying that the same request has not been submitted to any other notified body.

The technical documentation described in paragraph 3.

The applicant shall make available to the notified body a representative copy of the production concerned, hereinafter referred to as 'type'. The notified body may request other copies if required by the test programme.

A type may include different variants of the pressure equipment, provided that the differences between these variants do not affect the level of safety.

3. The technical documentation shall permit the assessment of the conformity of the equipment under pressure with the requirements of this Royal Decree that apply to it. To the extent necessary for such assessment, it shall reflect the design, manufacture and operation of the pressure equipment and shall include:

A general description of the type.

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

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

A list of the rules referred to in Article 5, applied in whole or in part, and the description of the solutions adopted to meet the essential requirements of this Royal Decree, where the rules have not been applied provided for in Article 5.

The results of the design calculations made, the controls performed, and so on.

The test reports.

The data for the tests planned during manufacturing.

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

4. The notified body:

4.1 Examine the technical documentation, check whether the type has been manufactured in accordance with the technical documentation and determine the elements that have been designed in accordance with the applicable provisions of the standards. referred to in Article 5, as well as the elements in the design of which the provisions relating to those standards have not been applied.

In particular, the notified body:

You will examine the technical documentation as far as the design and manufacturing procedures are concerned.

Evaluate the materials used, if these materials are not in conformity with the applicable harmonised standards or with a European approval of materials for pressure equipment, and verify the certificate issued by the manufacturer of the material in accordance with paragraph 4.3 of Annex I.

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

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

4.2 Realize or cause the appropriate checks and tests to be carried out to verify whether the solutions adopted by the manufacturer meet the essential requirements of this Royal Decree when they have not been applied the rules laid down in Article 5.

4.3 It will either make the appropriate checks and the necessary tests to check whether the relevant rules have actually been applied when the manufacturer has chosen its application.

4.4 The applicant shall agree with the applicant on the place where the necessary checks and tests will be carried out.

5. If the type complies with the relevant provisions of this Royal Decree, the notified body shall issue to the applicant an 'EC type' examination certificate. The certificate shall be valid for 10 years and shall include the name and address of the manufacturer, the conclusions of the control and the data necessary to identify the approved type.

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

If the notified body refuses to issue the EC type-examination certificate to the manufacturer or its representative established in the Community, the notified body shall give its decision in detail. There must be a review procedure.

6. The applicant shall inform the notified body that it retains the technical documentation relating to the 'EC type' examination certificate on any modification of the approved pressure equipment which is to be approved for further approval, where such modifications may affect conformity with the essential requirements or the conditions laid down for the use of the pressure equipment. This new approval shall be issued in the form of an appendix to the original "EC type" examination certificate.

7. Each notified body shall communicate to the Member States the relevant information on the 'EC type' examination certificates which it has withdrawn and, at the request of the Member States, on which it has issued.

Each notified body shall also communicate to the other notified bodies the relevant information on the 'EC type' examination certificates which it has withdrawn or refused.

8. The other notified bodies may receive copies of the EC type-examination certificates and their appendices. The Annexes to the certificates shall be kept at the disposal of the other notified bodies.

9. The manufacturer, or his authorised representative established in the Community, shall keep a copy of the 'EC type' examination certificates and their appendices together with the technical documentation for a period of 10 years from the date of manufacture of the last pressure equipment.

Where neither the manufacturer nor his representative is established in the Community, the obligation to keep the technical documentation available shall be the responsibility of the person placing the pressure equipment on the Community market.

Module B1 (EC design examination):

1. This module describes the part of the procedure by which a notified body checks and certifies that the design of a pressure equipment complies with the provisions of this Royal Decree that apply to it.

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

2. The manufacturer, or his authorised representative established in the Community, shall submit an application for an EC examination of the design to a single notified body.

The request will include:

The name, surname and address of the manufacturer and, if the application is submitted by a representative established in the Community, also the name, last name and address of the latter.

A written declaration specifying that the same request has not been submitted to any other notified body.

The technical documentation described in paragraph 3.

The application may refer to different variants of the pressure equipment, provided that the differences between the variants do not affect the level of safety.

3. The technical documentation shall permit the assessment of the conformity of the equipment under pressure with the requirements of this Royal Decree that apply to it. To the extent necessary for such assessment, it shall reflect the design, manufacture and operation of the pressure equipment and shall include:

A general description of the pressure equipment.

The design and manufacturing plans and the schemas of the elements, subassemblies, circuits, etc.

The descriptions and explanations necessary for the understanding of these plans and schemes and the operation of the pressure equipment.

A list of the rules provided for in Article 5, applied in whole or in part, and the description of the solutions adopted to meet the essential requirements of this Royal Decree, where the rules have not been applied provided for in Article 5.

The necessary evidence to justify that the solutions adopted in the design are appropriate, especially where the standards referred to in Article 5 have not been fully applied. Such tests shall include the results of the tests carried out by the appropriate laboratory of the manufacturer or on behalf of the manufacturer.

The results of the design calculations made, the controls performed, and so on.

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

4. The notified body:

4.1 It shall examine the technical documentation and determine the elements that have been designed, in accordance with the applicable provisions of the standards referred to in Article 5, as well as the elements in which the design is not have applied the provisions of those rules.

In particular, the notified body:

Evaluate the materials used, if they are not in conformity with the applicable harmonised standards or with a European approval of materials for pressure equipment.

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

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

4.2 It shall carry out the necessary examinations to verify whether the solutions adopted by the manufacturer meet the essential requirements of this Royal Decree, where the standards referred to in Article 5 have not been applied.

4.3 It will carry out the necessary tests to verify whether the relevant standards have been effectively applied when the manufacturer has chosen its application.

5. If the design is in accordance with the applicable provisions of this Royal Decree, the notified body shall issue to the applicant an EC design examination certificate. The certificate shall contain the name and address of the applicant, the conclusions of the examination, the conditions of validity, the data necessary for the identification of the approved design.

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

If the notified body refuses to issue the EC design examination certificate to the manufacturer or its representative established in the Community, the notified body shall give its decision in detail. There must be a review procedure.

6. The applicant shall inform the notified body that it retains the technical documentation relating to the EC design examination certificate on any modification to the approved design which is to be approved for further approval, where such modifications may affect conformity with the essential requirements or the conditions laid down for the use of the pressure equipment. This new approval shall be issued in the form of an appendix to the original EC design examination certificate.

7. Each notified body shall communicate to the Member States the relevant information on the EC design examination certificates which it has withdrawn and, at the request of the Member States, on which it has issued.

Each notified body shall also communicate to the other notified bodies the relevant information on the EC design examination certificates which it has withdrawn or refused.

8. Upon request, the other notified bodies may obtain the relevant information on:

The design EC exam certificate and its stubs.

The removal of EC design examination certificates and their appendices.

9. The manufacturer, or his authorised representative established within the Community, shall keep, together with the technical documentation referred to in paragraph 3, a copy of the EC design examination certificates and their appendices for a period of 10 years from the date of the date of manufacture of the last pressure equipment.

Where neither the manufacturer nor his representative is established in the Community, the obligation to keep the technical documentation available shall be the responsibility of the person placing the product on the Community market.

Module C1 (type compliance):

1. This module describes the part of the procedure whereby the manufacturer, or his authorised representative established in the Community, ensures and declares that the pressure equipment in question is in conformity with the type described in the EC examination certificate. of type " and comply with the requirements of this Royal Decree that apply to them. The manufacturer, or his authorised representative established in the Community, shall affix the CE marking to each unit of pressure equipment and make a written declaration of conformity.

2. The manufacturer shall take all necessary measures to ensure that the manufacturing process ensures the conformity of the pressure equipment manufactured with the type described in the EC type-examination certificate, as well as with the requirements of the Royal Decree that applies to you.

3. The manufacturer, or his authorised representative established in the Community, shall keep a copy of the declaration of conformity for a period of 10 years from the date of manufacture of the last pressure equipment.

Where neither the manufacturer nor his representative is established in the Community, the obligation to keep the technical documentation available shall be the responsibility of the person placing the pressure equipment on the Community market.

4. The final verification shall be subject to surveillance in the form of unannounced visits by a notified body chosen by the manufacturer.

During such visits, the notified body must:

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

Make sampling at the manufacturing or storage site of the pressure equipment for control purposes. The notified body shall determine the number of units of equipment to be sampled, as well as the need to perform or to make the final verification on the sample pressure equipment fully or partially carried out.

Where one or more pressure equipment is not in conformity, the notified body shall take appropriate action.

The manufacturer shall, under the responsibility of the notified body, set the identification number of the notified body.

Module D (Production Quality Assurance):

1. This module describes the procedure whereby the manufacturer who fulfils the obligations of paragraph 2 ensures and declares that the pressure equipment in question is in conformity with the type described in the EC type-examination certificate, or in the EC design examination certificate, and fulfil the requirements of this Royal Decree which apply to them. The manufacturer, or his authorised representative established in the Community, shall affix the CE marking to each unit of pressure equipment and make a written declaration of conformity.

The CE marking shall be accompanied by the identification number of the notified body responsible for the surveillance referred to in paragraph 4.

2. The manufacturer shall apply for production, final inspection and testing a quality system approved in accordance with paragraph 3 and shall be subject to the surveillance referred to in paragraph 4.

3. Quality System:

3.1 The manufacturer shall submit an application for the assessment of his quality system to a notified body of his choice.

This request will include:

All relevant information about the pressure equipment in question.

The documentation for the quality system.

The technical documentation of the approved type and a copy of the "EC type" examination certificate or EC design examination certificate.

3.2 The quality system shall ensure the conformity of the pressure equipment with the type described in the "EC type" examination certificate, or in the EC design examination certificate, and with the requirements of this Royal Decree which are applicable.

All the elements, requirements and provisions adopted by the manufacturer shall be contained in a documentation carried out in a systematic and orderly manner in the form of written measures, procedures and instructions. This documentation relating to the quality system shall allow for a uniform interpretation of the programmes, plans, manuals and quality records.

In particular, it will include an appropriate description of:

The quality objectives, the organization chart and the responsibilities of the management staff and their faculties regarding the quality of the pressure equipment.

The techniques, procedures and systematic measures of manufacture, quality assurance and quality assurance to be applied and, in particular, the methods of permanent union of the approved parts of the in accordance with paragraph 3.1.2 of Annex I.

The controls and tests that will be performed before, during, and after manufacturing, as well as how often they will be performed.

Quality dossiers, such as inspection reports and test and calibration data, reports on the competence or approval of the relevant staff and in particular those of the staff in charge of the permanent attachment of the parts and the performance of the non-destructive tests in accordance with paragraphs 3.1.2 and 3.1.3 of Annex I.

The means to monitor the achievement of the required quality and the effective functioning of the quality system.

3.3 The notified body shall evaluate the quality system to determine whether it meets the requirements referred to in paragraph 3.2. Those elements of the quality system which comply with the relevant harmonised standard shall be presumed to comply with the relevant requirements referred to in paragraph 3.2.

The team of auditors shall have at least one member who has experience in assessing the technology of the pressure equipment concerned. The assessment procedure shall include an inspection visit to the manufacturer's premises.

The decision will be notified to the manufacturer. The notification shall include the conclusions of the control and the reasoned assessment decision. There must be a review procedure.

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

The manufacturer, or his authorised representative established in the Community, shall keep the notified body which has approved the quality system informed of any adaptation provided for therein.

The notified body shall assess the proposed amendments and decide whether the modified quality system still complies with the requirements referred to in paragraph 3.2 or if a new assessment is required.

The body will notify the manufacturer of its decision. This notification shall include the conclusions of the control and the reasoned assessment decision.

4. Surveillance under the responsibility of the notified body:

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

4.2 The manufacturer shall allow access by the notified body to the manufacturing, inspection, testing and storage centres for inspection purposes and shall provide it with all the necessary information, in particular:

The documentation for the quality system.

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

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

4.4 In addition, the notified body may make visits to the manufacturer without notice. The need and frequency of such additional visits shall be determined from a control system by means of visits to be carried out by the notified body. The following factors shall be taken into account in the visit control system, in particular:

The category of the team.

The results of previous surveillance visits.

The need to check compliance with corrective measures.

When applicable, special conditions related to system approval.

Significant changes in the organization of production, measures or techniques.

In the course of such visits, the notified body may, if necessary, carry out or carry out tests in order to verify, if necessary, the proper functioning of the quality system. It will give the manufacturer a report of the visit and, if a test had been carried out, a test report.

5. For a period of 10 years from the date of manufacture of the last pressure equipment, the manufacturer shall have at the disposal of the national authorities:

The documentation referred to in the second indent of paragraph 3.1.

The adaptations referred to in the second subparagraph of paragraph 3.4.

The decisions and reports of the notified body referred to in the last subparagraph of paragraph 3.3 and the last subparagraph of paragraph 3.4, as well as paragraphs 4.3 and 4.4.

6. Each notified body shall communicate to the Member States the relevant information on quality system approvals which it has withdrawn and, at the request of those Member States, on which it has issued.

Each notified body shall also communicate to the other notified bodies the relevant information on quality system approvals which it has withdrawn or refused.

Module D1 (Production Quality Assurance):

1. This module describes the procedure by which the manufacturer who fulfils the obligations of paragraph 3 guarantees and declares that the pressure equipment considered meets the requirements of this Royal Decree which are applicable to them. The manufacturer, or his authorised representative established in the Community, shall affix the CE marking to each pressure equipment and make a written declaration of conformity. The CE marking shall be accompanied by the identification number of the notified body responsible for the surveillance referred to in paragraph 5.

2. The manufacturer shall draw up the technical documentation described below.

The technical documentation will allow the assessment of the conformity of the equipment under pressure with the requirements of this Royal Decree. To the extent necessary for such assessment, it shall reflect the design, manufacture and operation of the pressure equipment and shall include:

A general description of the pressure equipment.

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

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

A list of the rules provided for in Article 5, applied in whole or in part, and the description of the solutions adopted to meet the essential requirements of this Royal Decree, where the rules have not been applied provided for in Article 5.

The results of the design calculations made, the controls performed, and so on.

The test reports.

3. The manufacturer shall apply for production, final inspection and testing a quality system approved as specified in paragraph 4 and shall be subject to the surveillance referred to in paragraph 5.

4. Quality System:

4.1 The manufacturer shall submit an application for the assessment of his quality system to a notified body of his choice.

This request will include:

All relevant information about the pressure equipment in question.

The documentation for the quality system.

4.2 The quality system will ensure the conformity of the equipment under pressure with the requirements of this Royal Decree that apply to it.

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

In particular, it will include an appropriate description of:

The quality objectives, the organization chart and the responsibilities of the management staff and their faculties regarding the quality of the pressure equipment.

The techniques, procedures and systematic measures of manufacture, quality assurance and quality assurance to be applied and, in particular, the methods of permanent union of the approved parts of the in accordance with paragraph 3.1.2 of Annex I.

The controls and tests that will be performed before, during, and after manufacturing, as well as how often they will be performed.

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

The means to monitor the achievement of the required quality of the product and the effective functioning of the quality system.

4.3 The notified body shall evaluate the quality system to determine whether it meets the requirements referred to in paragraph 4.2. Those elements of the quality system which are in conformity with the relevant harmonised standard shall be deemed to be in conformity with the relevant requirements referred to in paragraph 4.2.

The team of auditors shall have at least one member who has experience in assessing the technology of the pressure equipment concerned. The assessment procedure shall include an inspection visit to the manufacturer's premises.

The decision will be notified to the manufacturer. The notification shall include the conclusions of the control and the reasoned assessment decision. There must be a review procedure.

4.4 The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it in such a way as to continue to be appropriate and effective.

The manufacturer, or his authorised representative established in the Community, shall keep the notified body which has approved the quality system informed of any adaptation provided for therein.

The notified body shall assess the proposed amendments and decide whether the modified quality system still complies with the requirements referred to in paragraph 4.2 or if a new assessment is required.

The body will notify the manufacturer of its decision. This notification shall include the conclusions of the control and the reasoned assessment decision.

5. Surveillance under the responsibility of the notified body:

5.1 The aim of the surveillance is to ensure that the manufacturer duly fulfils the obligations imposed on him by the approved quality system.

5.2 The manufacturer shall allow access by the notified body to the manufacturing, inspection, testing and storage centres for inspection purposes and shall provide it with all the necessary information, in particular:

The documentation for the quality system.

Quality records, such as inspection reports and test and calibration data, reports on staff competence, etc.

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

5.4 In addition, the notified body may make visits to the manufacturer without notice. The need and frequency of these additional visits shall be determined on the basis of a monitoring system of visits to be carried out by the notified body. The following factors shall be taken into account in the visit control system, in particular:

The category of the team.

The results of previous surveillance visits.

The need to check compliance with corrective measures.

When applicable, special conditions related to system approval.

Significant changes in the organization of production, measures or techniques.

In the course of such visits, the notified body may, if necessary, carry out or carry out tests in order to verify, if necessary, the proper functioning of the quality system. It will give the manufacturer a report of the visit and, if a test had been carried out, a test report.

6. For a period of 10 years from the date of manufacture of the last pressure equipment, the manufacturer shall have at the disposal of the national authorities:

The technical documentation referred to in paragraph 2.

The documentation referred to in the second indent of section 4.1.

The adaptations referred to in the second subparagraph of paragraph 4.4.

The decisions and reports of the notified body referred to in the last subparagraph of paragraph 4.3 and the last subparagraph of paragraph 4.4, as well as paragraphs 5.3 and 5.4.

7. Each notified body shall communicate to the Member States the relevant information on quality system approvals which it has withdrawn and, at the request of those Member States, on which it has issued.

Each notified body shall also communicate to the other notified bodies the relevant information on quality system approvals which it has withdrawn or refused.

Module E (Product Quality Assurance):

1. This module describes the procedure by which the manufacturer who fulfils the obligations of paragraph 2 ensures and declares that the pressure equipment is in conformity with the type described in the EC type-examination certificate and which complies with the requirements of this Royal Decree which apply to them. The manufacturer, or his authorised representative established within the Community, shall affix the CE marking to each product and make a written declaration of conformity. The CE marking shall be accompanied by the identification number of the notified body responsible for the surveillance referred to in paragraph 4.

2. The manufacturer shall apply for the final inspection and testing of pressure equipment a quality system approved in accordance with paragraph 3 and shall be subject to the surveillance referred to in paragraph 4.

3. Quality System:

3.1 The manufacturer shall submit an application for the assessment of his quality system to a notified body of his choice.

This request will include:

All relevant information about the pressure equipment in question.

The documentation for the quality system.

The technical documentation of the approved type and the copy of the "CE type" examination certificate.

3.2 In the context of the quality system, each pressure equipment shall be examined and appropriate tests shall be carried out in accordance with the relevant standard or standards set out in Article 5, or other equivalent tests, and, the final verification referred to in paragraph 3.2 of Annex I in order to ensure compliance with the relevant requirements of this Royal Decree. All the elements, requirements and provisions adopted by the manufacturer shall be contained in a systematic and orderly documentation in the form of written measures, procedures and instructions. The documentation on the quality system shall allow for a uniform interpretation of the programmes, plans, manuals and quality records.

In particular, it will include an appropriate description of:

The quality objectives, the organization chart and the responsibility of the management staff and their faculties in terms of the quality of the pressure equipment.

The controls and tests to be performed after manufacturing.

The means to verify the effective operation of the quality system.

Quality dossiers, such as inspection reports and test and calibration data, reports on the competence or approval of the relevant staff and in particular those of the staff in charge of the permanent attachment of the parts and the performance of the non-destructive tests in accordance with paragraphs 3.1.2 and 3.1.3 of Annex I.

3.3 The notified body shall evaluate the quality system to determine whether it meets the requirements referred to in paragraph 3.2. Those elements of the quality system which are in conformity with the relevant harmonised standard shall be deemed to be in conformity with the relevant requirements referred to in paragraph 3.2.

The team of auditors shall have at least one member who has experience in assessing the technology of the pressure equipment concerned. The assessment procedure shall include an inspection visit to the manufacturer's premises.

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

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

The manufacturer, or his authorised representative established in the Community, shall keep the notified body which has approved the quality system informed of any adaptation provided for therein.

The notified body shall assess the proposed amendments and decide whether the modified quality system still complies with the requirements referred to in paragraph 3.2 or if a new assessment is required.

The body will notify the manufacturer of its decision. This notification shall include the conclusions of the control and the reasoned assessment decision.

4. Surveillance under the responsibility of the notified body:

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

4.2 The manufacturer shall allow access by the notified body to the inspection, testing and storage centres for inspection purposes and shall provide it with all the necessary information, in particular:

The documentation on the quality system.

The technical documentation.

Quality records, such as inspection reports and test and calibration data, reports on staff qualification, and so on.

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

4.4 In addition, the notified body may make visits to the manufacturer without notice. The need and frequency of these additional visits shall be determined on the basis of a monitoring system of visits to be carried out by the notified body. The following factors shall be taken into account in the visit control system, in particular:

The category of the team.

The results of previous surveillance visits.

The need to check compliance with corrective measures.

When applicable, special conditions related to system approval.

Significant changes in the organization of production, measures or techniques.

In the course of such visits, the notified body may, if necessary, carry out or carry out tests in order to verify, if necessary, the proper functioning of the quality system. It will give the manufacturer a report of the visit and, if a test had been carried out, a test report.

5. For a period of 10 years from the date of manufacture of the last pressure equipment, the manufacturer shall have at the disposal of the national authorities:

The documentation referred to in the second indent of paragraph 3.1.

The adaptations referred to in the second subparagraph of paragraph 3.4.

The decisions and reports of the notified body referred to in the last subparagraph of paragraph 3.3 and the last subparagraph of paragraph 3.4, as well as paragraphs 4.3 and 4.4.

6. Each notified body shall communicate to the Member States the relevant information on quality system approvals which it has withdrawn and, at the request of those Member States, on which it has issued.

Each notified body shall also communicate to the other notified bodies the relevant information on quality system approvals which it has withdrawn or refused.

E1 Module (Product Quality Assurance):

1. This module describes the procedure by which the manufacturer who fulfils the obligations of paragraph 3 ensures and declares that the pressure equipment meets the requirements of this Royal Decree which apply to them. The manufacturer, or his authorised representative established in the Community, shall affix the CE marking to each pressure equipment and make a written declaration of conformity. The CE marking shall be accompanied by the identification number of the notified body responsible for the surveillance referred to in paragraph 5.

2. The manufacturer shall draw up the technical documentation described below.

The technical documentation will allow the assessment of the conformity of the equipment under pressure with the requirements of this Royal Decree. To the extent necessary for such assessment, it shall reflect the design, manufacture and operation of the pressure equipment and shall include:

A general description of the type.

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

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

A list of the rules provided for in Article 5, applied in whole or in part, and the description of the solutions adopted to meet the essential requirements of this Royal Decree, where the rules have not been applied provided for in Article 5.

The results of the design calculations made, the controls performed, and so on.

The test reports.

3. The manufacturer shall apply for the final inspection and testing of pressure equipment a quality system approved in accordance with paragraph 4 and shall be subject to the surveillance referred to in paragraph 5.

4. Quality System:

4.1 The manufacturer shall submit an application for the assessment of his quality system to a notified body of his choice.

This request will include:

All relevant information about the pressure equipment in question.

The documentation for the quality system.

4.2 In the context of the quality system, each pressure equipment shall be examined and the appropriate tests shall be carried out in accordance with the relevant standard or standards set out in Article 5, or equivalent tests, and, in the final verification referred to in paragraph 3.2 of Annex I, in order to ensure compliance with the relevant requirements of this Royal Decree. All the elements, requirements and provisions adopted by the manufacturer shall be contained in a systematic and orderly documentation in the form of written measures, procedures and instructions. The documentation on the quality system will allow for a uniform interpretation of the programmes, plans, manuals and quality records.

In particular, it will include an appropriate description of:

The quality objectives, the organization chart and the responsibilities of the management staff and their faculties regarding the quality of the pressure equipment.

The permanent joining methods for parts approved in accordance with paragraph 3.1.2 of Annex I.

The controls and tests to be performed after manufacturing.

Measured to verify the effective operation of the quality system.

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

4.3 The notified body shall evaluate the quality system to determine whether it meets the requirements referred to in paragraph 4.2. Those elements of the quality system which are in conformity with the relevant harmonised standard shall be presumed to comply with the relevant requirements referred to in paragraph 4.2.

The team of auditors shall have at least one member who has experience in assessing the technology of the pressure equipment concerned. The assessment procedure shall include an inspection visit to the manufacturer's premises.

The decision will be notified to the manufacturer. The notification shall include the conclusions of the control and the reasoned assessment decision. There must be a review procedure.

4.4 The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it in such a way as to continue to be appropriate and effective.

The manufacturer, or his authorised representative established in the Community, shall keep the notified body which has approved the quality system informed of any adaptation provided for therein.

The notified body shall assess the proposed amendments and decide whether the modified quality system still complies with the requirements referred to in paragraph 4.2 or if a new assessment is required.

The body will notify the manufacturer of its decision. This notification shall include the conclusions of the control and the reasoned assessment decision.

5. Surveillance under the responsibility of the notified body:

5.1 The aim of the surveillance is to ensure that the manufacturer duly fulfils the obligations imposed on him by the approved quality system.

5.2 The manufacturer shall allow access by the notified body to the inspection, testing and storage centres for inspection purposes and shall provide it with all the necessary information, in particular:

The documentation for the quality system.

The technical documentation.

Quality records, such as inspection reports and test and calibration data, reports on staff competence, and so on.

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

5.4 In addition, the notified body may make visits to the manufacturer without notice. The need and frequency of these additional visits shall be determined on the basis of a visit control system to be performed by the notified body. The following factors shall be taken into account in the visit control system, in particular:

The category of the team.

The results of previous surveillance visits.

The need to check compliance with corrective measures.

When applicable, special conditions related to system approval.

Significant changes in the organization of production, measures or techniques.

In the course of such visits, the notified body may, if necessary, carry out or carry out tests in order to verify, if necessary, the proper functioning of the quality system. It will give the manufacturer a report of the visit and, if a test had been carried out, a test report.

6. For a period of 10 years from the date of manufacture of the last pressure equipment, the manufacturer shall have at the disposal of the national authorities:

The technical documentation referred to in paragraph 2.

The documentation referred to in the second indent of section 4.1.

The adaptations referred to in the second subparagraph of paragraph 4.4.

The decisions and reports of the notified body referred to in the last subparagraph of paragraph 4.3 and the last subparagraph of paragraph 4.4, as well as paragraphs 5.3 and 5.4.

7. Each notified body shall communicate to the Member States the relevant information on quality system approvals which it has withdrawn and, at the request of those Member States, on which it has issued.

Each notified body shall also communicate to the other notified bodies the relevant information on quality system approvals which it has withdrawn or refused.

Module F (product verification):

1. This module describes the procedure whereby the manufacturer, or his authorised representative established in the Community, ensures and declares that the pressure equipment to which the provisions of paragraph 3 have been applied are in conformity with the type described:

In the "EC type" examination certificate, or in the EC design examination certificate and meet the corresponding requirements of this Royal Decree.

2. The manufacturer shall take all necessary steps to ensure that the manufacturing process ensures that the pressure equipment is in conformity with the type described:

In the "EC type" examination certificate, or in the EC design examination certificate and with the requirements of this Royal Decree that apply to you.

The manufacturer, or his authorised representative established in the Community, shall affix the CE marking to each pressure equipment and shall draw up a declaration of conformity.

3. The notified body shall carry out the appropriate examinations and tests to check whether the pressure equipment is in conformity with the relevant requirements of this Royal Decree by the control and testing of each product as specified in paragraph 4.

The manufacturer, or his authorised representative established in the Community, shall keep a copy of the declaration of conformity for a period of 10 years from the date of manufacture of the last pressure equipment.

4. Verification by control and testing of all pressure equipment:

4.1 All pressure equipment shall be individually examined and all appropriate controls and tests set out in the relevant standard or standards referred to in Article 5, or other examinations or tests, shall be carried out. equivalent, to verify their conformity with the type and with the requirements of this Royal Decree that apply to them.

In particular, the notified body:

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

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

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

4.2 The notified body shall fix or cause the identification number to be fixed on all pressure equipment and shall extend in writing a certificate of conformity concerning the tests carried out.

4.3 The manufacturer, or his authorised representative established in the Community, must be in a position to present the certificates of conformity issued by the notified body, if required.

G Module (CE Verification Per Unit):

1. This module describes the procedure by which the manufacturer guarantees and declares that the pressure equipment to which the certificate referred to in paragraph 4.1 has been issued are in conformity with the relevant requirements of this Royal Decree. The manufacturer shall affix the CE marking to each pressure equipment and extend a declaration of conformity.

2. The manufacturer shall submit the application for verification per unit to a notified body of his choice.

The request will include:

The name and address of the manufacturer and the placement of the pressure equipment.

A written statement specifying that a similar request has not been submitted to another notified body.

A technical documentation.

3. The technical documentation shall allow the assessment of the conformity of the equipment under pressure with the corresponding requirements of this Royal Decree and the understanding of the design, manufacture and operation of the pressure equipment.

The technical documentation will include:

A general description of the pressure equipment.

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

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

A list of the rules provided for in Article 5, applied in whole or in part, and the description of the solutions adopted to meet the essential requirements of this Royal Decree, where the rules have not been applied referred to in Article 5.

The results of the design calculations made, the controls performed, and so on.

The test reports.

The appropriate elements relating to the approval of the manufacturing and control procedures and to the competence or approval of the staff concerned, in accordance with paragraphs 3.1.2 and 3.1.3 of Annex I.

4. The notified body shall examine the design and manufacture of each pressure equipment and shall carry out appropriate tests for the manufacture referred to in the relevant standard or standards referred to in Article 5 of this Royal Decree, or equivalent tests and tests to check their conformity with the relevant requirements of this Royal Decree.

In particular, the notified body:

You will examine the technical documentation as far as the design and manufacturing procedures are concerned.

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

Approve the permanent joining methods of the parts, or verify whether they have been approved before, in accordance with paragraph 3.1.2 of Annex I.

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

It shall carry out the final inspection referred to in paragraph 3.2.1 of Annex I, perform or cause the test referred to in paragraph 3.2.2 of Annex I to be carried out and, where appropriate, examine the safety devices.

4.1 The notified body shall fix or cause the identification number to be fixed on each pressure equipment and shall issue a certificate of conformity concerning the tests carried out. This certificate shall be kept for a period of 10 years.

4.2 The manufacturer, or his authorised representative established in the Community, must be in a position to present the declaration of conformity and the certificate of conformity issued by the notified body, if they are required.

H Module (Total Quality Assurance):

1. This module describes the procedure whereby the manufacturer who fulfils the obligations laid down in paragraph 2 ensures and declares that the pressure equipment in question complies with the requirements of this Royal Decree which are applicable. The manufacturer, or his authorised representative established in the Community, shall affix the CE marking to each pressure equipment and make a written declaration of conformity. The CE marking shall be accompanied by the identification number of the notified body responsible for the surveillance referred to in paragraph 4.

2. The manufacturer shall apply an approved quality system for the design, manufacture, final inspection and testing, as specified in paragraph 3, and shall be subject to the surveillance referred to in paragraph 4.

3. Quality System:

3.1 The manufacturer shall submit an application for the assessment of his quality system to a notified body of his choice.

This request will include:

All the appropriate information about the pressure equipment in question.

The documentation for the quality system.

3.2 The quality system shall ensure the conformity of the equipment under pressure with the requirements of this Royal Decree that apply to it.

All the elements, requirements and provisions adopted by the manufacturer shall be contained in a documentation carried out in a systematic and orderly manner in the form of written measures, procedures and instructions. The documentation relating to the quality system shall allow for a uniform interpretation of the procedural and quality measures, such as programmes, plans, manuals and quality records.

In particular, it will include an appropriate description of:

The quality objectives, the organization chart and the responsibilities of the management staff and their faculties as regards the quality of the design and quality of the products.

The technical specifications of the design, including the implementing rules and, if the standards referred to in Article 5 are not fully applied, the means to be used to meet the requirements This Royal Decree is essential to apply to pressure equipment.

The design verification and verification techniques, the systematic procedures and measures to be used at the time of the design of the pressure equipment, in particular as regards the materials referred to in the paragraph 4 of Annex I.

The techniques, procedures and corresponding systematic measures to be applied for the manufacture, in particular the methods of permanent attachment of the parts approved in accordance with paragraph 3.1.2 of the Annex I, as well as for quality assurance and control.

The controls and tests that will be performed before, during, and after manufacturing, as well as how often they will be performed.

Quality dossiers, such as inspection reports and test and calibration data, reports on the competence or approval of the relevant staff and in particular those of the staff in charge of the permanent union of the parts and the performance of the non-destructive tests referred to in paragraphs 3.1.2 and 3.1.3 of Annex I.

The means of surveillance to control the achievement of the design and quality required for the pressure equipment and the effective operation of the quality system.

3.3 The notified body shall evaluate the quality system to determine whether it meets the requirements referred to in paragraph 3.2. Those elements of the quality system which are in conformity with the relevant harmonised standard shall be presumed to comply with the relevant requirements referred to in paragraph 3.2.

The audit team shall have at least one member who has experience in the assessment of the technology of the pressure equipment concerned. The assessment procedure shall include an inspection visit to the manufacturer's premises.

The decision will be notified to the manufacturer. The notification shall include the conclusions of the control and the reasoned assessment decision. There must be a review procedure.

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

The manufacturer, or his authorised representative established in the Community, shall keep the notified body which has approved the quality system informed of any adaptation provided for therein.

The notified body shall assess the proposed amendments and decide whether the modified quality system still complies with the requirements referred to in paragraph 3.2 or if a new assessment is required.

The body will notify the manufacturer of its decision. This notification shall include the conclusions of the control and the reasoned assessment decision.

4. Surveillance under the responsibility of the notified body:

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

4.2 The manufacturer shall allow the notified body's access to the design, manufacturing, inspection, testing and storage centres for inspection purposes and shall provide it with all the necessary information, in particular:

The documentation for the quality system.

The quality records foreseen in the part of the quality system dedicated to the design, such as the results of the analyses, the calculations, the tests, etc.

The quality records provided for in the part of the quality system dedicated to manufacturing, such as inspection reports and test and calibration data, reports on the competence of the staff to be treated, etc.

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

4.4 In addition, the notified body may make visits to the manufacturer without notice. The need and frequency of these additional visits shall be determined on the basis of a visit control system to be performed by the notified body. The following factors shall be taken into account in the visit control system, in particular:

The category of the team.

The results of previous surveillance visits.

The need to check compliance with corrective measures.

When applicable, special conditions related to system approval.

Significant changes in the organization of production, measures or techniques.

In the course of such visits, the notified body may, if necessary, carry out or carry out tests in order to verify, if necessary, the proper functioning of the quality system. It will give the manufacturer a report of the visit and, if a test had been carried out, a test report.

5. For a period of 10 years from the date of manufacture of the last pressure equipment, the manufacturer shall have at the disposal of the national authorities:

The documentation referred to in the second indent of the second subparagraph of paragraph 3.1.

The adaptations referred to in the second subparagraph of paragraph 3.4.

The decisions and reports of the notified body referred to in the last subparagraph of paragraph 3.3 and the last subparagraph of paragraph 3.4, as well as paragraphs 4.3 and 4.4.

6. Each notified body shall communicate to the Member States the relevant information on quality system approvals which it has withdrawn and, at the request of those Member States, on which it has issued.

Each notified body shall also communicate to the other notified bodies the relevant information on quality system approvals which it has withdrawn or refused.

H1 Module (full quality assurance with design control and special monitoring of final verification):

1. In addition to the requirements of module H the following provisions shall apply:

(a) The manufacturer shall submit a request for control of the design to the notified body.

(b) The application shall allow for the understanding of the design, manufacture and operation of the pressure equipment, as well as the assessment of its conformity with the requirements of this Royal Decree that apply to it.

The request will include:

The technical specifications of the design, including the rules that have been applied.

The necessary evidence to prove their suitability, in particular where the rules provided for in Article 5 have not been applied in full. These tests shall include the results of the tests carried out in the appropriate laboratory of the manufacturer or on behalf of the manufacturer.

(c) The notified body shall examine the application and, in the event that the design complies with the provisions of this Royal Decree applicable to it, issue an EC design examination certificate to the applicant.

The certificate shall include the conclusions of the examination, its conditions of validity, the data necessary for the identification of the approved design and, where appropriate, a description of the operation of the pressure equipment or its accessories.

(d) The applicant shall keep the notified body which has issued the EC design examination certificate informed of any approved design modification. The amendments shall be approved in addition to the notified body which has issued the EC design examination certificate in cases where the changes may affect conformity with the essential requirements of this Regulation. Royal Decree or with the conditions of use of the pressure equipment. This supplementary approval shall be in the form of an appendix to the original EC design examination certificate.

e) Each notified body shall also communicate to the other notified bodies the relevant information on the 'EC design' examination certificates which it has withdrawn or refused.

2. The final verification referred to in paragraph 3.2 of Annex I shall be subject to enhanced surveillance consisting of unannounced visits by the notified body. In the course of such visits the notified body shall carry out checks on the pressure equipment.

ANNEX IV Minimum criteria to be met for the designation of the notified bodies referred to in Article 12 and the recognised independent entities referred to in Article 13

1. The body, its director and the staff responsible for carrying out the verification and the assessment may not be the designer, the manufacturer, the supplier, the installer, the user of the pressure equipment or the assembly subject to the control of the body, nor the representative of either party. They shall not be directly involved in the design, manufacture, placing on the market or maintenance of the equipment under pressure or the whole or represent the parties involved in those activities. This shall not prevent the manufacturer of the pressure equipment or the assembly and the notified body from exchanging technical information.

2. The body and its staff shall carry out the assessment and verification operations with full professional integrity and full technical competence and freedom in respect of any pressure or incentive, in particular of a financial nature, which may influence their opinion or the results of the inspection, especially if they come from persons or groups of persons with interests in the results of the verifications.

3. The body shall have the necessary staff and resources to carry out appropriate technical and administrative tasks relating to the implementation of controls or surveillance; it shall also have access to the necessary equipment for the carry out extraordinary checks.

4. The staff responsible for the checks shall have:

A sound technical and professional training.

A satisfactory knowledge of the requirements regarding the controls carried out and sufficient practice in such controls.

The aptitude required to write the certificates, minutes and reports showing that the controls have been carried out.

5. The impartiality of the staff of the control body shall be ensured. Their remuneration will not vary according to the number of checks carried out or the result of such checks.

6. The body must take out civil liability insurance, unless such liability is covered by the State in accordance with the provisions of national law, or the controls are carried out directly by the Member State.

7. The staff of the body shall be subject to professional secrecy in relation to any information obtained in the performance of their duties (except to the competent administrative authorities of the State in which they carry out their activities), with the provisions of this Royal Decree or in any provision of national law that develops it.

ANNEX V

CE Marked

CE marking shall be constituted by the symbol "CE" according to the following logo:

(VIEW PAGE 20559 IMAGE)

In case the size of the CE marking is reduced or increased, the proportions of this logo should be retained.

The different elements of the CE marking must have the same vertical dimension, which cannot be less than 5 millimetres.

ANNEX VI

Declaration of Compliance

The "CE" declaration of compliance will include the following data:

Name, surname and address of the manufacturer or his authorised representative established in the Community.

Description of the team under pressure or set.

Procedure used for conformity assessment.

For sets, description of the pressure equipment that make up the assembly and indication of the procedure used for conformity assessment.

If applicable, name and address of the notified body that has carried out the check.

Where appropriate, the reference to the "EC type" examination certificate, the EC design examination certificate or the EC certificate of conformity.

If applicable, name and address of the notified body that controls the manufacturer's quality assurance system.

Where appropriate, the reference to the harmonised standards that have been applied.

Where appropriate, any other technical specifications that have been used.

Where appropriate, the reference to other Community Directives that have been applied.

Identification of the signatory with powers to bind the manufacturer or his authorised representative established in the Community.