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SSH ISO 18113-4:2022

In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 4: In vitro diagnostic reagents for self-testing

Aug 29, 2023

General information

60.60     Aug 29, 2023

DPS

DPS/KT 140

International Standard

11.100.10  

English  

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Published

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Scope

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.

Life cycle

NOW

PUBLISHED
SSH ISO 18113-4:2022
60.60 Standard published
Aug 29, 2023

Related project

Adopted from ISO 18113-4:2022 IDENTICAL