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

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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 18113-3:2011

This document specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) instruments intended for professional use. This document also applies to apparatus and equipment intended to be used with IVD instruments for professional use. 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 self-testing.

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BS EN ISO 18113-3:2024

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

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