International Standard
ISO 18113-3:2022
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 3: In vitro diagnostic instruments for professional use
Reference number
ISO 18113-3:2022
Edition 2
2022-10
International Standard
Read sample
ISO 18113-3:2022
79868
Published (Edition 2, 2022)

ISO 18113-3:2022

ISO 18113-3:2022
79868
Language
Format
CHF 63
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Abstract

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.

General information

  •  : Published
     : 2022-10
    : International Standard published [60.60]
  •  : 2
     : 10
  • ISO/TC 212
    11.100.10 
  • RSS updates

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