ISO 18113-2:2022

International Standard   Current Edition · Approved on 06 October 2022

In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 2: In vitro diagnostic reagents for professional use

ISO 18113-2:2022 Files

English 11 Pages
Current Edition
29.83 BHD

ISO 18113-2:2022 Scope

This document specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) reagents, calibrators and controls intended for professional use.

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 self-testing.

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