Standards with which the entities referred to in Article 41 have to comply

Activities related to testing for type-approval, to be carried out in accordance with the regulatory acts listed in Annex IV to this Directive: 1.1. Category A (tests performed in own facilities): EN ISO/IEC 17025: 2005 on the general requirements for the competence of testing and calibration laboratories. A technical service designated for category A activities may carry out or supervise the tests provided for in the regulatory acts for which it has been designated, in the facilities of a manufacturer or of a third party. 1.2. Category B (supervising of tests performed in the manufacturer’s facilities or in the facilities of a third party: EN ISO/IEC 17020: 2004 on the general criteria for the operation of various types of bodies performing inspection. Before performing or supervising any test in the facilities of a manufacturer or of a third party, the technical service shall check that the tests facilities and measurement devices comply with the appropriate requirements of the standard referred to in point 1.1. Activities related to Conformity of Production 2.1. Category C (procedure for the Initial Assessment and surveillance audits of the manufacturer’s quality management system): EN 45012: 1998 on the general requirements for bodies operating assessment and certification/registration of quality systems. 2.2. Category D (inspection or testing of production samples or supervision thereof): EN ISO/IEC 17020: 2004 on the general criteria for the operation of various types of bodies performing inspection.

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Source: EUR-Lex (Cellar) · retrieved 2026-10-28 · Text as adopted (Official Journal); later amendments are not incorporated in this text.