| 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:
|
| (a) |
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;
|
| (b) |
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;
|
| (c) |
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 market 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. |
|
Article 11
European approval for materials
|
| 1. |
European approval for materials, as defined in Article
1, section 2.9, shall be issued at the request of one or more manufacturers
of materials or equipment, by one of the notified bodies referred to in
Article 12 specifically designated
for that task. The notified body shall determine and perform, or arrange
for the performance of, the appropriate inspections and tests to certify
the conformity of the types of material with the corresponding requirements
of this Directive; in the case of materials recognized as being safe to
use before 29 November 1999, the notified body shall take account of the
existing data when certifying such conformity.
|
| 2. |
Before issuing European approval for materials, the notified body shall
inform the Member States and the Commission by sending them the appropriate
information. Within three months, a Member State or the Commission may
refer the matter to the Standing Committee set up by Article 5 of Directive
83/189/EEC, giving its reasons. In that case, the Committee shall issue
an opinion as a matter of urgency.
The notified body shall issue the European approval for materials taking
into account, where appropriate, the opinion of the Committee and the comments
submitted.
|
| 3. |
A copy of the European approval for pressure equipment materials shall
be sent to the Member States, the notified bodies and the Commission. The
Commission shall publish and keep up to date a list of European approvals
for materials in the Official Journal of the European Communities.
|
| 4. |
The materials used for the manufacture of pressure equipment conforming
with European approvals for materials, the references of which have been
published in the Official Journal of the European Communities, shall be
presumed to conform to the applicable essential requirements of Annex
I. |
|
