F1SCHEDULE 7(Annex II to the Directive)

Annotations:

CONFORMITY ASSESSMENT PROCEDURES

1

type examination may be carried out in any of the following manners—

  • — examination of a specimen, representative of the production envisaged, of the complete instrument (production type);

  • — assessment of the adequacy of the technical design of the instrument through examination of the technical documentation and supporting evidence referred to in point 1.3, plus examination of specimens, representative of the production envisaged, of one or more critical parts of the instrument (combination of production type and design type);

  • — assessment of the adequacy of the technical design of the instrument through examination of the technical documentation and supporting evidence referred to in point 1.3, without examination of a specimen (design type).