ISO 18113-4:2022

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

Publication date: Oct 6, 2022

General information

Current stage: 60.60 Effective date: Oct 6, 2022

Originator: ISO

Owner: ISO/TC 212

Type: International Standard

ICS: 11.100.10

Languages: English French

Buying

Status: Published

PDF - EC$183.61

Paper - EC$183.61

PDF and Paper - EC$367.22

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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

PREVIOUSLY

Revises
ISO 18113-4:2009

NOW

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

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