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ÖNORM EN ISO 18113-4:2024 10 01

Current

Current

The latest, up-to-date edition.

In vitro diagnostic medical devices - Provision of information by the manufacturer (labelling) - Part 4: Reagents for in vitro diagnostic studies for self-use (ISO 18113-4:2022)

Available format(s)

Hardcopy

Language(s)

German - English

Published date

01-10-2024

€147.32
Excluding VAT

This document specifies requirements for the information provided by the manufacturer of in vitro diagnostic (IVD) reagents, calibration materials, and control materials for self-use investigations.

Committee
ISO/TC 212
DocumentType
Standard
Pages
24
ProductNote
This standard also refers to ISO 14971, ISO 15223-1, ISO 18113-1
PublisherName
Osterreichisches Normungsinstitut/Austrian Standards
Status
Current
Supersedes

Standards Relationship
ISO 18113-4:2022 Identical
EN ISO 18113-4:2024 Identical

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