prSSH EN ISO 18113-5:2024

Pajisje mjekësore për diagnostikimin in vitro - Informacioni i dorëzuar nga prodhuesi (etiketimi) - Pjesa 5: Instrumentet e diagnostikimit in vitro për vetë - testim (ISO 18113-5:2009)

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2022)

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

Related directives

Directives related to this standards.