prSSH EN ISO 18113-4:2024

Pajisje mjekësore për diagnostikimin in vitro - Informacioni i dorëzuar nga prodhuesi (etiketimi) - Pjesa 4: Reagentët diagnostike për pajisjet in vitro për vetë - testim (ISO 18113-4:2009)

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2022)

Scope

This document specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) reagents, calibrators, and controls intended for self-testing.
This document can also be applicable to accessories.
This document is applicable to the labels for outer and immediate containers and to the instructions for use.
This document does not apply to:
a) IVD instruments or equipment;
b) IVD reagents for professional use.

Related directives

Directives related to this standards.