GSO ISO 18113-3:2024

ISO 18113-3:2022

Gulf Standard Current Edition · Approved on 14 October 2024

In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 3: In vitro diagnostic instruments for professional use

GSO ISO 18113-3:2024 Files

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GSO ISO 18113-3:2024 Scope

This document specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) instruments intended for professional use.

This document also applies to apparatus and equipment intended to be used with IVD instruments for professional use.

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 self-testing.