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ISO 18113-5:2022

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing
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ISO 18113-5:2022

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing

PUBLISH DATE 2022
ISO 18113-5:2022

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.

SDO ISO: International Organization for Standardization
Document Number ISO 18113
Publication Date Oct. 1, 2022
Language en - English
Page Count
Revision Level
Supercedes
Committee ISO/TC 212
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