Directive 94/9/EC: different categories within one product, or mixes of equipment and protective systems
Which conformity assessment procedures have to be performed in the case of different categories within one product, or mixes of equipment and protective systems according to Article 1.3 b ?
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 entity on the market. In the case of separate conformity assessment procedures for each part of the assembled equipment (called assembly in the Guidelines to Directive 94/9/EC), 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 has to be applied, which covers the highest requirements. The involved Notified Body shall include into the EC-type examination all aspects of the product. Existing conformity declarations of the manufacturer for parts of the product should be considered.
The Notified Body should inform the manufacturer about the possibilities of separate conformity assessment procedures for each part of the assembly as pointed out by the Guidelines to Directive 94/9/EC.
Any certificate issued by the Notified Body should make clear which aspects of the product have been assessed by the NB, 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 is conveying it in pipe-work 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.
With regard to the inlet and outlet connection the pump then has to comply with the requirements for category 1 equipment. The corresponding EC-type examination (equipment) has to be carried out by a Notified Body.
With regard to 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 EC-type examination certificate, making however clear which aspects of the product have been assessed by the NB, 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 EC 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 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 EC-type examination certificate for the pump as protective system.
In case that both aspects (equipment and protective system) have been assessed by the same Notified Body, only one EC-type examination certificate may be released.