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ISO 18113-4:2022

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

Oct 6, 2022

General information

60.60     Oct 6, 2022

ISO

ISO/TC 212

International Standard

11.100.10  

English   French  

Buying

Published

Language in which you want to receive the document.

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

PREVIOUSLY

WITHDRAWN
ISO 18113-4:2009

NOW

PUBLISHED
ISO 18113-4:2022
60.60 Standard published
Oct 6, 2022

National adoptions

SSH ISO 18113-4:2022  
DPS

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

60.60 Standard published

DPS/KT 140 more