Directive 2009/105/EC of the European Parliament and of the Council (repealed)Show full title

CHAPTER II CERTIFICATION

SECTION 1 Certification procedures

Article 8

1. Prior to production of pressure vessels of which the product of PS x V exceeds 50 bar.l, manufactured in accordance with the harmonised standards referred to in Article 5(1), the manufacturer, or his authorised representative established within the Community, shall at his own choice either:

(a) inform an approved inspection body as referred to in Article 9, which, after examining the design and manufacturing schedule referred to in point 3 of Annex II, shall draw up a certificate of adequacy attesting that the schedule is satisfactory; or

(b) submit a prototype vessel for the EC type-examination referred to in Article 10.

2. Prior to production of pressure vessels of which the product of PS x V exceeds 50 bar.l, not manufactured, or manufactured only partly, in accordance with the harmonised standards referred to in Article 5(1), the manufacturer, or his authorised representative established within the Community, shall submit a prototype vessel for the EC type-examination referred to in Article 10.

3. Vessels manufactured in accordance with the harmonised standards referred to in Article 5(1) or with the approved prototype shall, prior to their being placed on the market, be subject:

(a) to the EC verification referred to in Article 11 where the product of PS x V exceeds 3 000 bar.l;

(b) at the choice of the manufacturer, where the product of PS x V does not exceed 3 000 bar.l but exceeds 50 bar.l, either:

(i)

to the EC declaration of conformity referred to in Article 12; or

(ii)

to the EC verification referred to in Article 11.

4. The records and correspondence relating to the certification procedures referred to in paragraphs 1, 2 and 3 shall be drafted in an official language of the Member State in which the approved inspection body is established or in a language accepted by that body.

Article 9

1. Member States shall notify the Commission and the other Member States of the approved inspection bodies which they have appointed to carry out the procedures referred to in Article 8(1), (2) and (3) together with the specific tasks which those bodies have been appointed to carry out and the identification numbers assigned to them beforehand by the Commission.

The Commission shall publish in the Official Journal of the European Union a list of the notified bodies with their identification numbers and the tasks for which they have been notified. The Commission shall ensure that this list is kept up to date.

2. For the purposes of approval of the bodies referred to in paragraph 1, Member States shall meet the minimum criteria set out in Annex III.

3. A Member State which has approved an inspection body shall withdraw approval if it finds that the body no longer meets the minimum criteria set out in Annex III.

It shall immediately inform the Commission and the other Member States accordingly.

SECTION 2 EC type-examination

Article 10

1. EC type-examination is the procedure whereby an approved inspection body ascertains and certifies that a prototype vessel satisfies the provisions of this Directive which apply to it.

2. The application for EC type-examination shall be lodged by the manufacturer or by his authorised representative with a single approved inspection body in respect of a prototype vessel or of a prototype representing a family of vessels. That authorised representative must be established in the Community.

The application shall include:

(a) the name and address of the manufacturer or of his authorised representative and the place of manufacture of the vessels;

(b) the design and manufacturing schedule referred to in point 3 of Annex II.

It shall be accompanied by a vessel which is representative of the production envisaged.

3. The approved inspection body shall carry out the EC type-examination in the manner referred to in the second and third subparagraphs.

It shall examine not only the design and manufacturing schedule in order to check its conformity, but also the vessel submitted.

When examining the vessel, the body shall:

(a) verify that the vessel has been manufactured in conformity with the design and manufacturing schedule and may safely be used under its intended working conditions;

(b) perform appropriate examinations and tests to check that the vessel complies with the essential requirements applicable to it.

4. If the prototype complies with the provisions applicable to it the approved inspection body shall draw up an EC type-examination certificate which shall be forwarded to the applicant. That certificate shall state the conclusions of the examination, indicate any conditions to which its issue may be subject and be accompanied by the descriptions and drawings necessary for identification of the approved prototype.

The Commission, the other approved inspection bodies and the other Member States may obtain a copy of the certificate and, on a reasoned request, a copy of the design and manufacturing schedule and the reports on the examinations and tests carried out.

5. An approved inspection body which refuses to issue an EC type-examination certificate shall so inform the other approved inspection bodies.

An approved inspection body which withdraws an EC type-examination certificate shall so inform the Member State which approved it. The latter shall inform the other Member States and the Commission thereof, giving the reasons for the decision.

SECTION 3 EC verification

Article 11

1. EC verification is the procedure whereby a manufacturer or his authorised representative established within the Community ensures and declares that the vessels which have been checked in accordance with paragraph 3 are in conformity with the type described in the EC type-examination certificate or with the design and manufacturing schedule referred to in point 3 of Annex II having received a certificate of adequacy.

2. The manufacturer shall take all necessary measures for the manufacturing process to ensure that the vessels conform to the type described in the EC type-examination certificate or to the design and manufacturing schedule referred to in point 3 of Annex II. The manufacturer or his authorised representative established within the Community shall affix the ‘CE’ marking to each vessel and draw up a declaration of conformity.

3. The approved inspection body shall carry out the appropriate examinations and tests in order to check the conformity of the vessels with the requirements of this Directive by examination and testing of vessels in accordance with the second to tenth subparagraphs.

The manufacturer shall present his vessels in the form of uniform batches and shall take all necessary measures in order that the manufacturing process ensures the uniformity of each batch produced.

Those batches shall be accompanied by the EC type-examination certificate referred to in Article 10 or, where the vessels are not manufactured in accordance with an approved prototype, by the design and manufacturing schedule referred to in point 3 of Annex II. In the latter case the approved inspection body shall, prior to EC verification, examine the schedule in order to certify its conformity.

When a batch is examined, the approved inspection body shall ensure that the vessels have been manufactured and checked in accordance with the design and manufacturing schedule, and shall perform a hydrostatic test or a pneumatic test of equivalent effect on each vessel in the batch at a pressure Ph equal to 1,5 times the vessel’s design pressure in order to check its soundness. The pneumatic test shall be subject to acceptance of the test safety procedures by the Member State in which the test is performed.

Moreover, the approved inspection body shall carry out tests on test-pieces taken from a representative production test-piece or from a vessel, as the manufacturer chooses, in order to examine the weld quality. The tests shall be carried out on longitudinal welds. However, where differing weld techniques are used for longitudinal and circular welds, the tests shall be repeated on the circular welds.

For the vessels referred to in point 2.1.2 of Annex I, these tests on test-pieces shall be replaced by a hydrostatic test on five vessels taken at random from each batch in order to check that they conform to the essential safety requirements set out in point 2.1.2 of Annex I.

In the case of accepted batches, the approved inspection body shall affix its identification number, or cause that number to be affixed, to each vessel and shall draw up a written certificate of conformity relating to the tests carried out. All vessels in the batch may be placed on the market except for those which have not successfully undergone a hydrostatic test or a pneumatic test.

If a batch is rejected, the approved inspection body shall take appropriate measures to prevent the placing on the market of that batch. In the event of frequent rejection of batches, the approved inspection body may suspend the statistical verification.

The manufacturer may, under the responsibility of the approved inspection body, affix the latter’s identification number during the manufacturing process.

The manufacturer or his authorised representative must be able to supply on request the approved inspection body’s certificates of conformity referred to in the seventh subparagraph.

SECTION 4 EC declaration of conformity

Article 12

1. A manufacturer fulfilling the obligations arising under Article 13 shall affix the ‘CE’ marking provided for in Article 16 to vessels which he declares to be in conformity with:

(a) the design and manufacturing schedule referred to in point 3 of Annex II in respect of which a certificate of adequacy has been drawn up; or

(b) an approved prototype.

2. By the EC declaration of conformity procedure the manufacturer becomes subject to EC surveillance, in cases where the product of PS x V exceeds 200 bar.l.

The purpose of EC surveillance is to ensure, as required by the second paragraph of Article 14, that the manufacturer duly fulfils the obligations arising under Article 13(2). Surveillance shall be performed by the approved inspection body which issued the EC type-examination certificate referred to in the first subparagraph of Article 10(4) where the vessels have been manufactured in accordance with an approved prototype or, if this is not the case, by the approved body to which the design and manufacturing schedule was sent in accordance with Article 8(1)(a).

Article 13

1. Where a manufacturer makes use of the procedure referred to in Article 12, he shall, before commencing manufacture, send the approved inspection body which issued the EC type-examination certificate or the certificate of adequacy a document describing the manufacturing processes and all of the predetermined systematic measures taken to ensure conformity of the pressure vessels to the standards referred to in Article 5(1) or the approved prototype.

2. The document referred to in paragraph 1 shall include:

(a) a description of the means of manufacture and checking appropriate to the construction of the vessels;

(b) an inspection document describing the appropriate examinations and tests to be carried out during manufacture, together with the procedures in respect thereof and the frequency with which they are to be performed;

(c) an undertaking to carry out the examinations and tests in accordance with the inspection document referred to in point (b) and to have a hydrostatic test or, subject to the agreement of the Member State, a pneumatic test carried out on each vessel manufactured at a test pressure equal to 1,5 times the design pressure;

those examinations and tests shall be carried out under the responsibility of qualified staff who are sufficiently independent from production personnel, and shall be the subject of a report;

(d) the addresses of the places of manufacture and storage and the date on which manufacture is to commence.

3. When the product of PS x V exceeds 200 bar.l, manufacturers shall authorise access to the said places of manufacture and storage by the body responsible for EC surveillance, for inspection purposes, and shall allow that body to select sample vessels and shall provide it with all necessary information, and in particular:

(a) the design and manufacturing schedule;

(b) the inspection report;

(c) the EC type-examination certificate or certificate of adequacy, where appropriate;

(d) a report on the examinations and tests carried out.

Article 14

The approved inspection body which issued the EC type-examination certificate or certificate of adequacy shall, before the date on which any manufacture begins, examine both the document referred to in Article 13(1) and the design and manufacturing schedule referred to in point 3 of Annex II, in order to certify its conformity, where vessels are not manufactured in accordance with an approved prototype.

In addition, where the product of PS x V exceeds 200 bar.l, that body shall during manufacture:

(a)

ensure that the manufacturer actually checks series-produced vessels in accordance with Article 13(2)(c);

(b)

take random samples at the places of manufacture or at the place of storage of vessels for inspection purposes.

The approved inspection body shall supply the Member State which approved it and, on request, the other approved inspection bodies, the other Member States and the Commission, with a copy of the inspection report.