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Royal Decree 108/2016, Of 18 March, Establishing The Essential Safety Requirements For The Marketing Of Simple Pressure Vessels Are Set.

Original Language Title: Real Decreto 108/2016, de 18 de marzo, por el que se establecen los requisitos esenciales de seguridad para la comercialización de los recipientes a presión simples.

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(d) The maximum service pressure of the container shall be less than or equal to 30 bar and the product of such pressure by the capacity of the container (PS × V) shall not exceed 10,000 bar.L.

e) The minimum service temperature shall not be less than -50 ° C or the maximum temperature, greater than 300 ° C for steel containers or at 100 ° C, for aluminium or aluminium alloy containers.

3. This royal decree does not apply to:

(a) The vessels specifically designed for nuclear use in which a failure can produce a radioactivity emission.

(b) Containers specifically designed for the equipment or propulsion of ships or aircraft.

c) Fire extinguishers.

Article 2. Definitions.

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

1. Marketing: Any supply, paid or free, of a container for distribution or use on the European Union market in the course of a commercial activity.

2. Market Introduction: The first placing on the European Union market of a container.

3. Manufacturer: A natural or legal person who manufactures a vessel or who is responsible for the design or manufacture of the container and places such a vessel on its registered name or trade mark.

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

5. Importer: Any natural or legal person established in the European Union who places in the market of the European Union a vessel from a third country.

6. Distributor: Any natural or legal person integrated in the distribution chain, other than the manufacturer or importer, who places a container on the market.

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

8. Technical specification: A document that defines the technical requirements of a canister.

9. Harmonised standard: harmonised standard as defined in point (c) of point 1 of Article 2 of Regulation (EU) No 1025/2012.

10. Accreditation: Accreditation under the definition of Article 2 (10) of Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008.

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

12. Conformity assessment: The process by which it is assessed whether the essential safety requirements of this royal decree are met in relation to a container.

13. Conformity assessment body: A body that performs conformity assessment activities, including calibration, testing, certification and inspection.

14. Recovery: Any measure to obtain the return of a container already made available to the end user.

15. Withdrawal: Any measure intended to prevent the placing on the market of a vessel in the supply chain.

16. European Union harmonisation legislation: All European Union legislation to harmonise the conditions for the placing on the market of containers.

17. CE marking: A marking by which the manufacturer indicates that the vessel is in conformity with all applicable requirements laid down in the harmonisation legislation of the European Union providing for its placement.

18. Notified control bodies: Those who comply with the provisions of Royal Decree 2200/1995 of 28 December 1995 on the Regulation of the Infrastructure for the Quality and Safety of Industry and Article 21 of this Royal Decree a decree, and are notified to the European Commission and the other Member States to carry out the conformity assessment tasks referred to in Articles 14 and 15.

Article 3. Marketing and commissioning.

1. Only those vessels which, properly installed, maintained and used in accordance with their destination, comply with the requirements of this royal decree may be placed on the market and put into service.

2. The provisions of this royal decree shall apply without prejudice to the national and regional rules laid down to ensure the protection of persons and, in particular, workers using such vessels, provided that this does not suppose modifications of such containers in an unspecified form in this royal decree.

Article 4. Essential requirements.

1. Vessels of which the product of PS × V exceeds 50 bar.L shall comply with the essential safety requirements set out in Annex I.

2. Vessels of which the product of PS × V is less than or equal to 50 bar.L shall be designed and manufactured in accordance with the latest developments in this field in one of the Member States.

Article 5. Free movement.

It shall not be possible to prohibit, restrict or impede the placing on the market and putting into service of simple pressure vessels which comply with this royal decree.

CHAPTER II

Obligations of economic operators

Article 6. Obligations of manufacturers.

1. When placing on the market vessels of which the product of PS × V exceeds 50 bar.L, manufacturers shall ensure that they have been designed and manufactured in accordance with the essential safety requirements set out in Annex I.

By placing on the market vessels of which the product of PS × V is less than or equal to 50 bar.L, manufacturers shall ensure that they have been designed and manufactured in accordance with the latest developments in this field. Member States.

2. For vessels of which the product of PS × V is greater than 50 bar.L, manufacturers shall draw up the technical documentation referred to in Annex II and ensure that the relevant procedure for the assessment of the product is carried out. compliance referred to in Article 13.

When it has been demonstrated by this procedure that a vessel of which the product of PS × V exceeds 50 bar.L meets the applicable requirements, manufacturers shall draw up an EU declaration of conformity and affix the marking. EC and the entries set out in point 1 of Annex III.

Manufacturers shall ensure that vessels of which the product of PS × V is less than or equal to 50 bar.L bear the inscriptions set out in point 1 of Annex III.

3. Manufacturers shall keep the technical documentation and the EU declaration of conformity for a>2. This royal decree applies to simple pressure vessels ("containers"). Serial manufactured with the following characteristics:

(a) The containers shall be welded, intended to be subjected to a relative internal pressure greater than 0,5 bar and to contain air or nitrogen, and shall not be used for flame.

(b) The parts and assemblies that contribute to the resistance of the pressure vessel shall be manufactured, either of non-alloy steel, or of non-alloy aluminium or of untempered aluminium alloys.

c) The container shall consist of the following elements:

c.1) Well by a cylindrical part of circular cross section, closed by pumped funds having their concavity outwards or by flat bottoms having the same axis of revolution as the cylindrical part.

c.2) Well for two pumped funds that have the same axis of revostrate the conformity of the container with the present royal decree, at least in Spanish. At the request of the Autonomous Communities or the Ministry of Industry, Energy and Tourism, they shall cooperate in any action aimed at avoiding the risks posed by the vessels which they have placed on the market.

Article 9. Obligations of distributors.

1. When placing a container on the market, distributors shall act with due diligence in relation to the requirements of this royal decree.

2. Before placing on the market a vessel of which the product of PS x V exceeds 50 bar.L, the distributors shall ensure that the vessel bears the CE marking and the inscriptions provided for in point 1 of Annex III is accompanied by the required documents and the instructions and safety information referred to in point 2 of Annex III, at least in Spanish, and that the manufacturer and the importer have complied with the requirements laid down in Article 6; paragraphs 5 and 6, and in Article 8 (3) respectively.

Where a distributor considers or has reason to believe that a vessel of which the product of PS x V is greater than 50 bar.L is not in conformity with the essential safety requirements of Annex I, it shall not introduce such a vessel into the market until it is compliant. In addition, where the vessel presents a risk, the distributor shall inform the manufacturer or the importer thereof, as well as the autonomous communities in which they placed them on the market.

Before placing on the market a vessel of which the product of PS × V is less than or equal to 50 bar.L, distributors shall ensure that it bears the inscriptions provided for in point 1.2 of Annex III and is accompanied by the instructions and safety information referred to in point 2 of Annex III, at least in Spanish, and that the manufacturer and the importer have complied with the requirements laid down in Article 6 (5) and (6) and Article 8; paragraph 3, respectively.

3. Where they are responsible for a vessel of which the product of PS x V exceeds 50 bar.L, distributors shall ensure that the conditions of their storage or transport do not jeopardise compliance with the essential safety requirements. of Annex I.

4. Distributors who consider or have reason to believe that a vessel they have placed on the market is not in conformity with this royal decree shall ensure that the corrective measures necessary to bring it into conformity are taken, and may be withdrawn. the market or recover it, if necessary. In addition, where the vessel presents a risk, distributors shall immediately inform the autonomous communities in which they placed it on the market and provide details, in particular, of non-compliance and corrective measures. adopted.

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

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

For the purposes of this Royal Decree, it shall be considered a manufacturer and shall therefore be subject to the obligations of the manufacturer in accordance with Article 6, an importer or distributor who places a vessel on the market. with its trade name or mark or modify a container that has already been placed on the market so that its compliance with this royal decree may be affected.

Article 11. Identification of economic operators.

At the request of the Autonomous Communities or the Ministry of Industry, Energy and Tourism, the economic agents will identify:

a) Any economic agent that has supplied them with a container.

b) Any economic agent to which they have supplied a container.

Economic operators should be able to provide such information for 10 years after they have been supplied with the container and for 10 years after they have supplied the container.

CHAPTER III

Conformity of containers with a product of PS × V exceeding 50 bar.L

Article 12. Presumption of conformity of vessels of which the product of PS x V exceeds 50 bar.L.

Containers of which the product of PS x V exceeds 50 bar.L which are in conformity with harmonised standards or parts thereof the references of which have been published in the Official Journal of the European Union shall be presumed to be in conformity with the the essential safety requirements referred to in Annex I to which those standards or parts thereof apply.

Article 13. Procedures for the assessment of conformity.

1. Before manufacture, the containers of which the product of PS × V exceeds 50 bar.L shall be subject to the EU-type examination (Module B) set out in point 1 of Annex II, as follows:

(a) For containers manufactured in accordance with the harmonised standards referred to in Article 12, in one of the following ways, at the choice of the manufacturer:

a.1) Assessment of the adequacy of the technical design of the container, by examining the technical documentation and supporting documentation, without examining a sample (module B: type of design).

a.2) Assessment of the adequacy of the technical design of the vessel by examination of the technical documentation and supporting documentation, with examination of a model of vessel representative of the intended production of the vessel full container (module B: production type).

(b) In respect of containers not manufactured or manufactured only partially in accordance with the harmonised standards referred to in Article 12, the manufacturer shall present a representative vessel model for examination. of the intended production of the complete container and the technical documentation and supporting documentation for the examination and assessment of the adequacy of the technical design of the container (module B: type of production).

2. Before placing on the market, the containers shall be subjected to one of the following procedures:

(a) Where the product of PS × V exceeds 3,000 bar.L, to the conformity with the type based on the internal control of the production plus supervised test of the vessels (Module C1), as set out in point 2 of Annex II.

(b) Where the product PS × V is less than or equal to 3,000 bar.L and more than 200 bar.L, at the choice of the manufacturer, one of the following:

b.1) Conformity with the type based on the internal control of the most supervised production of the vessels (Module C1) set out in point 2 of Annex II.

b.2) Conformity with the type based on the internal control of the production plus supervised control of the years after the vessel has been placed on the market, importers shall keep a copy of the EU declaration of conformity at the disposal of the vessels. autonomous communities or the Ministry of Industry, Energy and Tourism and shall ensure that, upon request, such authorities receive a copy of the technical documentation.

9. In response to a reasoned request from the Autonomous Communities or the Ministry of Industry, Energy and Tourism, importers shall provide all necessary information and documentation, in paper or electronic form, to demonried out, ensuring the transparency and the possibility of reproduction of these procedures, and of strategies and appropriate procedures to distinguish between tasks carried out as a control body and any other activity.

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

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

The personnel performing the compliance assessment tasks will have:

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

2. A satisfactory knowledge of the requirements of the assessments you make and the authority needed to perform them.

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

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

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

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

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

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

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

Article 21. Subsidiaries and subcontracting of notified bodies.

1. Where the notified control body subcontracts specific tasks related to conformity assessment or has recourse to a subsidiary, it shall ensure that the subcontractor or the subsidiary complies with the requirements laid down in Article 20 and inform the Ministry of Industry, Energy and Tourism accordingly.

2. The notified control body shall assume full responsibility for the tasks performed by the subcontractors or the subsidiaries, irrespective of where they are based.

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

4. The notified inspection body shall keep at the disposal of the autonomous communities and the Ministry of Industry, Energy and Tourism the relevant documents concerning the assessment of the qualifications of the subcontractor or the subsidiary, as well as the work carried out in accordance with point 3.2 of Annex I and Annex II.

Article 22. Request for notification.

1. The control bodies shall submit a request for notification to the competent authority of the autonomous community where it has been established in accordance with the Regulation on the Infrastructure for Quality and Safety of Industrial Royal Decree 2200/1995 of 28 December.

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

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

Article 23. Notification to the European Commission and to the other Member States.

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

2. The notification shall include information on the conformity assessment activities, the conformity assessment module (s), the vessel (s) concerned and the relevant accreditation certificate (s).

3. The inspection body may carry out its activities whenever the European Commission and the other Member States do not object within two weeks of the notification. After this deadline will be considered a notified body of control, only for the purposes of this royal decree.

4. Each control body, even when notified under various European Union rules and legal acts, shall have an identification number assigned by the European Commission, which shall be published on a list, and together with the activities of the European Commission. for which you have been notified.

Article 24. Changes to the notification.

1. If it is found that a notified control body no longer complies with the requirements laid down in Article 20, or is failing to fulfil its obligations, the Ministry of Industry, Energy and Tourism may restrict, suspend or withdraw the notification, depending on the case, depending on the seriousness of the non-compliance with the requirements or obligations, and inform the European Commission, the other Member States and the Autonomous Communities.

2. In the event of withdrawal, restriction or suspension of the notification or the notified body having ceased its activity, the competent authority of the autonomous community in which it carries out its activity shall take appropriate measures to ensure that the files from that body are processed by another notified body, as appropriate or mtified, independently to perform the tasks of the body itself or be carried out on its behalf and under its responsibility. At all times, in respect of each conformity assessment procedure and for each type or category of vessels for which it has been notified, the conformity assessment body shall have the following:

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

2. of the descriptions of the procedures under which conformity assessment is carisional measures taken, and the latter shall inform the European Commission and the other Member States of such measures, which in the event of Disagreement with them may raise objections in this respect.

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

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

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

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

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

7. The autonomous communities shall ensure that appropriate restrictive measures are taken without delay in respect of the vessel concerned, such as the withdrawal from the market of the container.

8. Where a restrictive measure adopted on a non-compliant vessel is received from a Member State or the European Commission, the Ministry of Tourism and Trade shall inform the Autonomous Communities of the measure in question and, in the case of They will be able to raise their objections to the measure. Those objections shall be analysed and, where appropriate, referred to the European Commission.

Article 31. The safeguard procedure of the European Union.

1. If, upon completion of the procedure laid down in Article 30.3 and 4, objections are raised against measures taken, or if the European Commission considers that such measures are contrary to European Union law, the the safeguard procedure of the European Union.

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

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

Article 32. Compliant containers that present a risk.

1. If, after an assessment pursuant to Article 30.1, a vessel is found to be a vessel, although in accordance with this royal decree, it presents a risk to the health or safety of persons, to domestic animals or to property, the relevant economic operator shall be required to take all appropriate measures to ensure that the vessel concerned does not present that risk when it is placed on the market or to withdraw it from the market or to recall it within the reasonable time, proportional to the nature of the risk to be determined.

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

3. The Ministry of Industry, Energy and Tourism shall immediately inform the European Commission and the other Member States thereof. The information provided shall include all available details, in particular the data necessary to identify the container in question and determine its origin, the supply chain of the vessel, the nature of the risk posed and the nature and duration of the measures taken. The European Commission will assess these measures and take a decision on this to be communicated to all Member States and the economic operators involved.

Article 33. Formal non-compliance.

1. Without prejudice to Article 30, if one of the following situations is found, the relevant economic operator shall be required to remedy the lack of conformity in question:

(a) The CE marking has been affixed in violation of Article 30 of Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 or Article 16 of this Royal Decree.

b) CE marking has not been placed.

(c) The identification number of the notified body involved in the production control phase has been placed, in breach of Article 16 or not placed in the place of the notified body.

(d) The inscriptions referred to in point 1 of Annex III have not been placed or have been placed in breach of Article 16 or point 1 of Annex III.

e) The EU declaration of compliance is not set.

f) The EU declaration of compliance was not set correctly.

g) The technical documentation is not available or incomplete.

h) The information referred to in Article 6 (6) or Article 8 (3) is either false or incomplete.

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

2. If the lack of conformity referred to in paragraph 1 persists, the Autonomous Communities shall take all appropriate measures to restrict or prohibit the placing on the market of the vessel or to ensure that it is recovered or withdrawn from the market.

CHAPTER VI

Sanctioning Regime

Article 34. Sanctioning regime.

The breaches of the provisions of this royal decree will apply to them the regime of infringements and penalties laid down in Title V of Law 21/1992, of 16 July, of Industry.

First transient disposition. Placing on the market or putting into service of vessels placed on the market before 20 April 2016.

The placing on the market or putting into service of vessels regulated by the previous rules which are in conformity with the same and which have been placed on the market before 20 April 2016 shall not be prevented.

Second transient disposition. Certificates issued in advance pursuant tant corrective measures are taken in relation to all the vessels concerned which it has placed on the market throughout the European Union.

4. If the relevant economic operator does not take appropriate corrective action, the autonomous communities shall take all appropriate provisional measures to prohibit or restrict the placing on the national market of the vessel, to withdraw it. of that market or recover it.

The autonomous communities concerned shall inform the Ministry of Industry, Energy and Tourism of the provhen designing the container, the manufacturer shall define the scope of use and choose:

a.1) The minimum service temperature Tmin.

a.2) The maximum service temperature Tmax

a.3) The maximum PS service pressure.

However, if a minimum service temperature greater than -10 ° C is selected, the characteristics required of the materials shall be met at -10 ° C.

(b) In addition, the manufacturer shall take into account the following provisions:

b.1) It will be possible to inspect the inside of the containers.

b.2) It will be possible to purge the canisters.

b.3) The mechanical characteristics shall persist during the period of use of the container for the intended purpose.

b.4) The containers shall be suitably protected against corrosion, in accordance with their prescribed purpose.

(c) The manufacturer shall take into account that, under the intended conditions of use:

c.1) The vessels shall not be subjected to tensions which may impair their employment security.

c.2) The internal pressure shall not exceed, on a permanent basis, the maximum service pressure PS; however, a momentary overpressure of up to 10% shall be permitted.

d) Circumferential or longitudinal joints shall be made by welding at full penetration or by means of welds of equivalent efficacy. Non-Hemispheric pumped funds shall be provided with a cylindrical edge.

2.1 Thickness of the walls. If the PS × V container is less than or equal to 3,000 bar.L, the manufacturer shall select one of the methods described in paragraphs 2.1.1 and 2.1.2 to determine the thickness of the container walls; if the PS × V container is greater than 3,000 bar.L or if the maximum service temperature exceeds 100 ° C, the thickness shall be determined by the method described in paragraph 2.1.1.

However, the actual thickness of the wall of the glass and the bottoms shall be at least equal to 2 mm for the steel containers and 3 mm for the aluminium or aluminium alloy containers.

2.1.1 Method of calculation. The minimum thickness of the parts under pressure shall be calculated on the basis of the intensity of the stresses and taking into account the following provisions:

a) The calculated pressure to be taken into account will be greater than or equal to the maximum service pressure PS selected.

b) The overall permissible membrane voltage shall be less than or equal to the lower of the 0.6 RET or 0.3 Rmvalues. To determine the permissible voltage, the manufacturer shall use the RET and Rm values minimum guaranteed by the manufacturer of the material.

However, when the cylindrical part of the container comprises one or more longitudinal welds carried out by means of non-automatic procedure, the thickness calculated in accordance with the procedure specified in the first subparagraph shall be multiplied by the coefficient 1,15.

2.1.2 Experimental Method. The thickness of the walls shall be determined in such a way as to allow the containers to withstand at room temperature a pressure at least 5 times greater than the maximum service pressure, with a lower permanent circumferential deformation factor equal to 1%.

3. Manufacturing processes

The vessels shall be constructed and subjected to production controls in accordance with points 2, 3 or 4 of Annex II.

3.1 Preparing the components. The preparation of the components (e.g. conformed and chambered) shall not cause defects in the surface, cracks or changes in the mechanical characteristics of the components which may impair the safety of the containers.

3.2 Welding of pressure-subjected parts. Welds and adjacent areas shall have characteristics similar to that of the welded material and shall be free from surface or internal defects, which are detrimental to the safety of the vessels.

The welds will be made by welders or specialized operators with the appropriate degree of fitness, according to the authorized welding methods. Such authorisations and ratings shall be carried out by notified bodies.

In addition, the manufacturer shall ensure, during manufacture, the constancy of the quality of the welds by performing, in accordance with the appropriate modalities, the necessary tests. Such tests shall be the subject of a report.

4. Putting into service of the containers

The containers shall be accompanied by the instructions drawn up by the manufacturer, as set out in point 2 of Annex III.

ANNEX II

Compliance assessment procedures

1. EU-type examination

(Module B)

1.1 The EU-type examination is the part of a conformity assessment procedure whereby a notified body examines the technical design of a vessel and verifies and attests that its technical design complies with the requirements of the requirements of this Directive which apply to it.

1.2 The EU type examination shall be carried out in any of the following forms in accordance with Article 13:

The assessment of the adequacy of the technical design of the container, by examination of the technical documentation and supporting documentation referred to in point 1.3, plus the examination of a container model, representative of the intended production of the entire container (type of production).

The assessment of the adequacy of the technical design of the container, by examination of the technical documentation and supporting documentation referred to in point 1.3, without examining a vessel model (type of design).

1.3 The manufacturer shall submit an EU-type examination application to a single notified body of his choice.

This request will include:

(a) The name and address of the manufacturer and, if the application is submitted by the authorised representative, also the name and address of the authorised representative.

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

c) The technical documentation. The technical documentation shall allow the conformity of the vessel with the applicable requirements of this Directive to be assessed and shall include an appropriate risk assessment and assessment. It shall specify the applicable requirements and shall, in so far as it is relevant for the assessment, design, manufacture and operation of the vessel, shall include, where appropriate, at least the following elements:

c.1) A general description of the canister.

c.2) Design and manufacturing plans, and components schemas, etc.

c.3) The descriptions and explanations necessary for the understanding aluminium or aluminium alloy suitable and compatible with the materials used for the manufacture of the parts under pressure.

Such materials shall have, at the minimum service temperature, a fracture elongation and an appropriate bending energy.

1.4 Parts not under pressure. All parts of the containers not under pressure and joined by welding shall be of materials compatible with that of the components to which they are welded.

2. Design of the containers

(a) W 1.7 and 1.9, provided that they are specified in his mandate.

2. Conformity to the type based on internal control of the most supervised production of the vessels

(Module C1)

2.1 The conformity with the type based on the internal control of the production plus supervised test of the vessels is the part of a conformity assessment procedure whereby the manufacturer complies with the obligations set out in points 2.2, 2.3 and 2.4, and ensures and declares, under its sole responsibility, that the vessels concerned are in conformity with the type described in the EU-type examination certificate and fulfil the requirements of the This Directive applies to them.

2.2 Manufacturing. The manufacturer shall take all necessary measures to ensure that the manufacturing process and its monitoring ensure the conformity of the containers manufactured with the type described in the EU-type examination certificate and with the requirements of the present Directive that they apply to them.

Before manufacturing starts, the manufacturer shall provide the notified body of his/her choice with all the necessary information and in particular:

a) The technical documentation to include equally:

Certificates relating to the appropriate qualification of the welding operating method and the welders or operators in charge of welding.

The inspection sheet of the materials used for the manufacture of the parts and components that contribute to the pressure vessel resistance.

A report on examinations and tests performed.

(b) The inspection file describing the appropriate examinations and tests with their procedures and frequency of execution, to be carried out in the manufacturing process.

c) The EU type examination certificate.

2.3 Container control.

2.3.1 For each container manufactured, the notified body shall carry out appropriate examinations and tests to verify the conformity of the containers with the type described in the EU-type examination certificate and with the corresponding requirements of this Directive in accordance with the following points:

(a) The manufacturer shall present its containers in homogeneous batches and shall take all necessary measures to ensure that the manufacturing process ensures the homogeneity of the lots produced.

(b) When examining a batch, the notified body shall verify that the containers have been manufactured and checked in accordance with the technical documentation and, in order to verify their resistance, shall submit each container of the batch to a hydrostatic test or a pneumatic test whose effectiveness is equivalent to a pH pressure equal to 1,5 times the calculation pressure. The pneumatic test shall depend on whether or not the safety procedures of the test are accepted by the Member State in which the test is carried out.

(c) In addition, in order to verify the quality of the welds, the notified body shall carry out tests on samples taken, at the choice of the manufacturer, of a sample representative of the production or of a vessel. The tests shall be carried out on longitudinal welds. However, when a different welding method is used in the longitudinal and circumferential welds, the tests shall also be performed with the circumferential welds.

(d) In the case of containers subject to the experimental method referred to in point 2.1.2 of Annex I, the tests of the samples shall be replaced by a hydrostatic test carried out with five randomly selected vessels of each lot, in order to verify their compliance with the essential safety requirements set out in point 2.1.2 of Annex I.

(e) In the accepted lots, the notified body shall affix or cause the identification number to be affixed to each vessel and shall extend a certificate of conformity concerning the tests carried out. All the containers in the lot may be placed on the market, except for containers declared unfit in the hydrostatic test or the pneumatic test.

(f) If a lot is rejected, the notified body shall take the necessary measures to prevent the placing on the market of the lot in question. In the case of frequent batch rejections, the notified body may suspend the statistical verification.

g) The manufacturer shall be able to issue, if requested by the competent authorities, the certificates of conformity of the notified body referred to in point (e).

2.3.2 The notified body shall provide a copy of its inspection report to the Member State which has notified it and, if so requested, to the other notified bodies, to the other Member States and to the Commission.

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

2.4 CE marking and EU declaration of conformity.

2.4.1 The manufacturer shall affix the CE marking to each vessel that is in conformity with the type described in the EU-type examination certificate and satisfies the applicable requirements of this Directive.

2.4.2 The manufacturer shall draw up an EU declaration of conformity for each vessel model and keep it at the disposal of the national authorities for a period of 10 years after the vessel has been introduced into the vessel. market. The EU declaration of conformity shall identify the container for which it has been drawn up.

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

2.5 Authorized Representative. The manufacturer's obligations referred to in point 2.4 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in his mandate.

3. Compliance with the type based on internal control of the production plus monitored control of the vessels at random intervals

(Module C2)

3.1 The conformity with the type based on the internal control of the production plus supervised control at random intervals of the vessels is the part of a conformity assessment procedure whereby the the manufacturer fulfils the obligations set out in points 3.2, 3.3 and 3.4, and ensures and declares, under his sole responsibility, that the vessels concerned are in conformity with the type described in the EU-type examination certificate and comply with the requirements of the requirements of this Directive that apply to them.

3.2 Manufacturing.

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

3.2.2 Before manufacturing starts, the manufacturer shall provide the notified body of his/her choice with all the necessary information and in e manufacturer until the end of the validity of the examination certificate. certificate.

1.9 The manufacturer shall keep at the disposal of the national authorities a copy of the EU-type examination certificate, its annexes and additions, as well as the technical documentation for a period of 10 years after the date of the introduction of the container into the market.

1.10 The manufacturer's authorised representative may submit the application referred to in point 1.3 and fulfil the obligations referred to in pointsthe CE marking to each vessel in accordance with the type described in the EU type-examination certificate and satisfy the applicable requirements of this Directive.

4.3.2 The manufacturer shall draw up an EU declaration of conformity for each vessel model and keep it at the disposal of the national authorities for a period of 10 years after the vessel has been introduced into the vessel. market. The EU declaration of conformity shall identify the container for which it has been drawn up.

4.3.3 A copy of the EU declaration shall be made available to the competent authorities upon request.

4.4 Authorized Representative. The manufacturer's obligations referred to in point 4.3 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in his mandate.

ANNEX III

Inscriptions, instructions, definitions, and symbols

1. EEC marking markings

1.1 The vessels of which the PS × V container is greater than 50 bar.L shall bear the CE marking provided for in Annex II to Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 and the last two figures for the year of affixing of the CE marking.

1.2 The containers or their descriptive plate shall bear at least the following inscriptions:

a) Maximum service pressure (PS in bar).

b) The maximum service temperature (Tmax in ° C).

c) The minimum service temperature (Tmin in ° C).

d) The capacity of the canister (V in L).

e) The name, registered trade name or trademark and address of the manufacturer.

f) The type and serial number or batch of the canister.

1.3 When a descriptive plate is used, it will be designed in such a way that it cannot be reused and will include a free space that allows other data to be included.

2. Security instructions and information

The instructions will contain the following information:

a) The details mentioned in point 1.2, except the serial number of the container.

b) The use to which the canister is intended.

c) The maintenance and installation conditions required to ensure the safety of the containers.

3. Definitions and symbols

3.1 Definitions:

(a) The calculation pressure 'P' is the relative pressure chosen by the manufacturer and used to determine the thickness of the parts of the container under pressure.

b) The maximum service pressure "PS" is the maximum relative pressure that can be exerted under normal conditions of container utilization.

c) The minimum service temperature "Tmin" is the lowest stabilized temperature of the container wall under normal conditions of use.

d) The maximum service temperature "Tmax" is the highest stable temperature of the container wall under normal conditions of use.

e) The elasticity limit "RET" is the value, at the maximum service temperature Tmax:

e.1) Well of the upper limit of elasticity ReH, for materials that present an upper and lower limit of elasticity.

e.2) Well of the conventional elasticity limit of 0.2% Rp0.2

e.3) Well of the conventional elasticity limit of 1.0% Rp1.0 for non-alloy aluminum.

(f) Container categories: The containers are part of the same category if they differ only from the model as to the diameter, provided that the requirements referred to in points 2.1.1 and 2.1.2 of Annex I are complied with; or as to the length of its cylindrical part within the following limits:

f.1) When the model is constituted, in addition to the funds, by one or more swerve, the variants shall comprise at least one virola.

f.2) When the model is made up of only two pumped funds, the variants shall not comprise swerve.

Length variations that involve modifications of the openings and/or tubules, shall be indicated in the plan of each variant.

g) The batches of containers shall be up to 3,000 containers of the same model.

h) There is serial manufacturing, in accordance with this Directive, when several containers of the same model are manufactured according to a continuous manufacturing process for a given period, in accordance with a common design and by means of The same manufacturing procedures.

i) Inspection file: Document in which the manufacturer of the materials certifies that the container supplied conforms to the characteristics of the order and in which it exposes the results of routine control tests manufacture, and in particular the chemical composition and mechanical characteristics, carried out both in containers manufactured in the same production process and in the supply, but not necessarily in the containers delivered.

3.2 Symbols:

PS

A

Breakage (Lo = 5.65).

%

80 mm

Breakage (Lo = 80 mm).

%

KCV

Break Energy by flexing.

J/cm2

P

Calculation pressure.

bar

bar

h

Hydrostatic test pressure or tire.

bar

R p0.2

Conventional elasticity limit 0.2%.

N/mm2

R eT

elasticity limit to the maximum service temperature.

N/mm2

R eH

Upper elasticity limit.

N/mm2

R

d.4) The address of the places of manufacture and storage, as well as the date on which manufacture begins.

Before the start of manufacture, the notified body shall examine these documents in order to certify their conformity with the EU type-examination certificate.

4.3 CE marking and EU declaration of conformity.

4.3.1 The manufacturer shall affix ub>m

Resistance to traction.

N/mm2

R m, max

Maximum Resistance to the traction.

N/mm2

R p1.0

Conventional Limit elasticity of 1.0%.

N/mm2

max

Maximum temperature of service.

° C

min

Minimum Service Temperature.

° C

V

Canister capacity.

L

ANNEX IV

EU Declaration of Conformity (n. XXXX) (1)

(1) The manufacturer will be optional to assign a number to the compliance declaration.

1. Canister canister/model (canister, type, batch, or serial number):

2. Name and address of the manufacturer and, where applicable, that of his authorised representative:

3. This declaration of conformity is issued under the sole responsibility of the manufacturer:

4. Purpose of the declaration (identification of the container allowing its traceability; if necessary for the identification of the container, an image may be included):

5. The purpose of the statement described above is in accordance with the relevant harmonisation legislation of the European Union:

6. References to the relevant harmonised standards used, or references to the other technical specifications for which conformity is declared:

7. The notified body ... (name, number) ... has made ... (description of the intervention) ... and issue the certificate: ...

8. Additional information:

Signed on behalf of:

(Place and date of issue):

(Name, charge) (signature):