§90 一つの製品の中に異なるカテゴリーがある場合の適合性評価手続

A question arises on which conformity assessment procedures must be performed in the case of different categories within one product, or mixes of equipment and protective systems according to Article 1(1)(a).

If a product is made of parts which are assigned to different conformity assessment procedures it will be up to the manufacturer to decide how these parts and the whole product shall be placed on the market. The manufacturer can decide to realise the appropriate conformity assessment procedures for each part or for the whole product, even if he decides to place the product as an entirety on the market. In the case of separate conformity assessment procedures for each part of the combined/ assembled equipment ("assembly") the manufacturer may presume conformity of these pieces of equipment and may restrict his own risk assessment of the assembly to those additional ignition and other hazards, which become relevant because of the final combination. If additional hazards are identified a further conformity assessment of the assembly regarding these additional risks is necessary.

If the manufacturer explicitly asks a notified body to assess the entire product, then that conformity assessment procedure, which covers the highest requirements, has to be applied. The notified body shall include into the EU-type examination (if relevant) all aspects of the product. Existing conformity declarations of the manufacturer for parts of the product should be given due consideration.

The notified body should inform the manufacturer about the possibilities of separate conformity assessment procedures for each part of the assembly.

Any certificate issued by the notified body should make clear which aspects of the product have been assessed by the notified body, and which have been assessed by the manufacturer alone.

Example: Vapour recovery pump for petrol stations (a) The pump is sucking the petrol vapour-air mixture from the atmosphere and conveying it in pipework attributed to zone 0. Accordingly, it is connected at its inlet and outlet to a potentially explosive atmosphere classified as zone 0. The pump itself is placed in a zone 1 environment.

Regarding the inlet and outlet connection the pump then must comply with the requirements for category 1 equipment. The corresponding EU-type examination (equipment) must be carried out by a notified body. Regarding the remaining (outer) body and integrated parts of the pump the notified body includes the necessary category 2 assessment into the certification, even if there are only non-electrical ignition sources to be considered.

Both categories shall be indicated in the EU-type examination certificate, making clear which aspects of the product have been assessed by the notified body, and which have been assessed by the manufacturer alone, and in the marking. For those category 2 parts of the pump, which show only non-electrical ignition sources, and which are placed separately on the market, and for which the technical documentation has been communicated to a notified body, an EU declaration of conformity (for equipment) or a written attestation of conformity (for components) of the manufacturer are sufficient.

(b) Often the pump is expected to prevent the passage of a deflagration flame from the inlet to the outlet connection, as typical vapour recovery pumps contain flame arresters in the inlet and outlet pipe. In this case the pump simultaneously may qualify as a protective system (in-line deflagration arrester).

A notified body – after having carried out a corresponding assessment of the flame arresting capability – may then issue a separate EU-type examination certificate for the pump as a protective system. In case that both aspects (equipment and protective system) have been assessed by the same notified body, only one EU-type examination certificate may be issued.