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ISO 18113-4:2022

Current

Current

The latest, up-to-date edition.

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

Available format(s)

Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users

Language(s)

English, French

Published date

06-10-2022

€60.00
Excluding VAT

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.

DocumentType
Standard
Pages
11
PublisherName
International Organization for Standardization
Status
Current
Supersedes

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