Regulation 18 EC verification by batch (statistical method)
Where a manufacturer or his authorised representative established in the Community submits a batch of appliances or fittings to a notified body for verification under this regulation together with an undertaking to pay the appropriate fee, the approved body shall carry out an examination and tests of appliances or fittings in the batch in accordance with paragraph (2) below to establish whether items in the batch—
conform with the relevant EC type-examination certificate; and
satisfy the essential requirements and the provisions of the Directive which apply to it.
The notified body shall examine and carry out tests on appliances or fittings in the batch by reference to a sampling plan designed to ensure—
a standard quality level corresponding to a 95% probability of acceptance with a range of non-conformity between 0.5% and 1.5%; and
a limit quality corresponding to a 5% probability of acceptance with a percentage of non-conformity between 5% and 10%.
If, having carried out the examination, the notified body is satisfied that an EC certificate of conformity should be issued it shall, on payment of the appropriate fee, issue an EC certificate of conformity which—
shall identify any appliance or fitting in the batch with which the notified body is not satisfied having regard to the foregoing provisions of this regulation; and
shall be retained by the manufacturer or his authorised representative established in the Community.
Where the notified body issues an EC certificate of conformity in respect of a batch, the manufacturer or his authorised agent established in the Community—
may supply any appliance or fitting in the batch other than one within subparagraph (b) below; and
shall not supply any appliance or fitting which is identified in the EC certificate of conformity as one with which the notified body was not satisfied.
Where the notified body declines to issue an EC certificate of conformity in respect of a batch,—
the notified body shall take all reasonable steps to ensure that no appliance or fitting in the batch is supplied by any person; and
no person shall supply any appliance or fitting which was comprised in the batch.
If, having regard to the objectives of the Directive, it appears to the notified body that the number of batches of appliances or fittings to which an EC type-examination certificate applies and in respect of which it has declined to issue an EC certificate of conformity is unsatisfactory, it may suspend verification under this regulation in respect of appliances or fittings to which that EC type-examination certificate applies.
In this regulation, “batch” means a number of appliances or fittings—
all of which are of the same model and have the same design characteristics; and
in the case of appliances, to all of which the manufacturer has affixed the EC mark in accordance with regulation 24 and the distinguishing number or mark of the notified body to which the batch is submitted under this regulation.