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Norm

ISO 18113-3:2022

Issue date: 2022 10 06

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

This document specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) instruments intended for professional use. This document al...
Valid
Publisher:
International Organization for Standardization
Format:
Digital | 10 Pages
Language:
English

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.

ISO 18113-3:2022
2022 10 06
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 3:...
Norm
ISO 18113-3:2009
2009 12 09
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 3:...
Norm