Standard

ISO 18113-4:2022

Oct 2022 Current

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Abstract

This document specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) reagents, calibrators, and controls intended for self-testing. This document can also be applicable to accessories. This document is applicable to the labels for outer and immediate containers and to the instructions for use. This document does not apply to: a) IVD instruments or equipment; b) IVD reagents 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 18113-4:2009

ISO 18113-4:2022

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ISO 18113-4:2022

ISO 18113-4:2009

Abstract

Products specifications

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ISO 18113-4:2022

ISO 18113-4:2009

Abstract

Products specifications

Product Relations

Product life cycle