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BS EN ISO 18113-5:2024

Current

Current

The latest, up-to-date edition.

Part 5: In vitro diagnostic instruments for self-testingIn vitro diagnostic medical devices — Information supplied by the manufacturer (labelling)

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

31-07-2024

€243.07
Excluding VAT

Committee
CH/212
DocumentType
Standard
Pages
24
PublisherName
British Standards Institution
Status
Current
Supersedes

This document specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) instruments intended for self-testing. This document is also applicable to apparatus and equipment intended to be used with IVD instruments for self-testing. This document can also be applicable to accessories. This document does not apply to: a) instructions for instrument servicing or repair; b) IVD reagents, including calibrators and control materials for use in control of the reagent; c) IVD instruments for professional use.

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