International Standard
ISO 18113-5:2022
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testing
Reference number
ISO 18113-5:2022
Edition 2
2022-10
© ISO 2024
International Standard
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Published (Edition 2, 2022)

ISO 18113-5:2022

Format
Language
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 self-testing.

This document is also applicable to apparatus and equipment intended to be used with IVD instruments for self-testing.

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 professional use.

General information

  • Status
     : Published
    Publication date
     : 2022-10
    Stage
    : International Standard published [60.60]
  • Edition
     : 2
    Number of pages
     : 10
  • Technical Committee :
    ISO/TC 212
    ICS :
    11.100.10 
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