, the manufacturer shall subject each item of equipment to one of the conformity assessment procedures described in Annex III, according to the conditions given in this Article.Directive 97/23/EC
1.1. Before placing pressure equipment on the market , the manufacturer shall subject each item of equipment to one of the conformity assessment procedures described in Annex III, according to the conditions given in this Article.
1.2. The conformity assessment procedures to be applied to an item of pressure equipment with a view to affixing the CE marking shall be determined by the category, as defined in Article 9, in which the equipment is classified. 1.3. The conformity assessment procedures to be applied for the various categories are as follows:
- category 1
Module A
- category Il
Module A1
Module D1
Module E1
- category III
Module B1 + D
Module B + E
Module B + C1
Module H
- category IV
Module G
Module H1
1.4. Pressure equipment shall be subjected to one of the conformity assessment procedures which may be chosen by the manufacturer among those laid down for the category in which it is classified. The manufacturer may also choose to apply one of the procedures which apply to a higher category, if available.
1.5. In the framework of quality assurance procedures for equipment in categories III and IV referred to in Article 3, section 1.1 (a), section 1.1 (b) first indent and section 1.2, the notified body shall, when performing unexpected visits, take a sample of equipment from the manufacturing or storage premises in order to perform, or have performed, the final assessment as referred to in Annex I, section 3.2.2. To this end, the manufacturer shall inform the notified body of the intended schedule of production. The notified body shall carry out at least two visits during the first year of manufacturing. The frequency of subsequent visits shall be determined by the notified body on the basis of the criteria set out in section 4.4 of the relevant modules.
1.6. In the case of one-off production of vessels and equipment in Category III referred to in Article 3, section 1.2 under the module H procedure, the notified body shall perform or have performed the final assessment, as referred to in Annex I, section 3.2.2, for each unit. To this end, the manufacturer shall communicate the intended schedule of production to the notified body.
2. Assemblies referred to in Article 3 (2) shall be subjected to a global conformity assessment procedure comprising:
assessment of each item of pressure equipment making up the assembly and referred to in Article 3 (1) which has not been previously subjected to a conformity assessment procedure and to a separate CE marking; the assessment procedure shall be determined by the category of each item of equipment;
the assessment of the integration of the various components of the assembly as referred to in sections 2.3, 2.8 and 2.9 of Annex I which shall be determined by the highest category applicable to the equipment concerned other than that applicable to any safety accessories;
the assessment of the protection of an assembly against exceeding the permissible operating limits as referred to in sections 2.10 and 3.2.3 of Annex I shall be conducted in the light of the highest category applicable to the items of equipment to be protected.
3. By way of derogation from paragraphs 1 and 2, the competent authorities may, where justified, allow the placing on the marker and putting into service in the territory of the Member State concerned of individual pressure equipment items and assemblies referred to in Article 1 (2), in respect of which the procedures referred to in paragraphs 1 and 2 of this Article have not been applied and the use of which is in the interests of experimentation.
4. Records and correspondence relating to conformity assessment shall be drawn up in the official language(s) of the Community which may be determined in accordance with the Treaty by the Member State where the body responsible for carrying out these procedures is established, or in a language accepted by that body.