21/30416045 DC

This standard 21/30416045 DC BS EN ISO 18113-5. 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 self-testing.

This document also applies to apparatus and equipment intended to be used with in vitro diagnostic (IVD) instruments for self-testing.

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 professional use.