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
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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