Standard

ISO 18113-5:2022

Oct 2022 Current

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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.

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Standard from ISO
Published: October 6 2022
Edition: 2
Document type: IS
Pages
ISBN:

Publisher: ISO
Distributor: ISO
ICS: 11.100.10
International TC: ISO/TC 212

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Revises: ISO 18113-5:2009

ISO 18113-5:2022

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ISO 18113-5:2022

ISO 18113-5:2009

Abstract

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ISO 18113-5:2022

ISO 18113-5:2009

Abstract

Products specifications

Product Relations

Product life cycle