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Monitoring of Manufacturers in Explosion Protection

Working Group 3.64


  • Office for Sek1-Ex in the conformity assessment department (KBS) of PTB
  •  Manufacturing surveillance of Ex-manufacturers within the scope of Directive 2014/34/EU    (ATEX) and the IECEx-system
  •  Laboratory inspections and witness tests as a precondition for the acknowledgement of    manufacturer measurements according to IECEx OD 024 in connection with a type  examination to issue an IECEx CoC.

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    Manufacturing surveillance:


    The requirements to a quality management system for Ex-manufacturers are described in

    EN ISO/IEC 80079-34 and hence form the basis for manufacturing surveillance according to Directive 2014/34/EU    (ATEX) as well as the IECEx-system. For the conformity assessment procedure (Chapter II, Article 8) to be carried out by the manufacturer, Directive 2014/34/EU (ATEX) generally requires compliance with two annexes of this Directive in each case. In addition to the procedure of the EU-type examination according to annex III the procedure of quality assurance of the production process according to annex IV has to be applied in most cases for equipment of equipment category 1. Equipment of equipment category 2 is mostly subject to the procedure of product quality assurance according to annex VII.Annexes IV and VII of the Directive require surveillance of the measures for quality assurance under the responsibility of the notified body. The inspection of the production site by the notified body is absolutely necessary. This so-called Ex-audit – when performed by PTB – is always based on a valid system certificate according to ISO 9001 of theEx-manufacturer.Uniformity respecting the implementation of annexes IV and VII of the ATEX Directive is achieved by application of the “GUIDELINES ON THE MANAGEMENT OF ASSESSMENT AND SURVEILLANCE PROGRAMMES FOR PRODUCT COVERED BYANNEX IV AND VII OF THE ATEX DIRECTIVE“


    Laboratoty inspection:

    The IECEx Operational Document OD 024 was published in October 2010 in order to regulate the acknowledgement of manufacturer measurements within the scope of IECEx-certificates (CoC’s) according to IECEx02.

    Basically, Document OD 024 distinguishes between two possible test procedures:

    1. Witness-test of an Ex-product performed by an employee of the manufacturer, supervised by an employee or representative of Ex-TL (PTB).

    2. On-site test of an Ex-product performed by an employee or representative of Ex-TL (PTB) at the manufacturing location using own test equipment or test equipment provided by the manufacturer.

    Furthermore, the range of services of working group 3.64 includes the performance of initial or sequential laboratory inspections to evaluate the appropriateness of the test facilities as well as the competence of the test personnel at the manufacturer for the intended scope of testing.




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