BS EN ISO 18113-5:2024

In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling). Part 5: In vitro diagnostic instruments for self-testing | Status: Current

1 Scope This document specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) instruments intended for self-testing. This document is also applicable to apparatus and equipment intended to be used with IVD instruments for self-testing. This document can also be applicable to accessories. This document does not apply to:

1. a) instructions for instrument servicing or repair;
2. b) IVD reagents, including calibrators and control materials for use in control of the reagent;
3. c) IVD instruments for professional use.