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BS EN ISO 18113-2:2024

Current

Current

The latest, up-to-date edition.

In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) In vitro diagnostic reagents for professional use

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

12-06-2024

€243.07
Excluding VAT

Committee
CH/212
DocumentType
Standard
Pages
26
PublisherName
British Standards Institution
Status
Current
Supersedes

This document specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) reagents, calibrators and controls intended for professional use. 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 self-testing.

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