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Norm

ISO 18113-3:2022

Ausgabedatum: 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...
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Herausgeber:
International Organization for Standardization
Format:
Digital | 10 Seiten
Sprache:
Englisch

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