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

Publisher

British Standards Institution

Committee	CH/212
DocumentType	Standard
Pages	26
PublisherName	British Standards Institution
Status	Current
Supersedes	BS EN ISO 18113-2:2011

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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BS EN ISO 18113-2:2024

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

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