21/30416037 DC

This standard 21/30416037 DC BS EN ISO 18113-3. In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) is classified in these ICS categories:

• 11.100.10 In vitro diagnostic test systems

This document specifies requirements for information supplied by the manufacturer of IVD instruments intended for professional use.

This document also applies to apparatus and equipment intended to be used with IVD instruments for professional use.

This document can also be applied to accessories.

This document does not apply to:

1. instructions for instrument servicing or repair;

2. IVD reagents, including calibrators and control materials for use in control of the reagent;

3. IVD instruments for self-testing.