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EN ISO 18113-4:2011

Withdrawn

Withdrawn

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009)

Published date

10-19-2011

Withdrawn date

10-31-2014

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ISO 18113-4:2009 specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) reagents for self-testing.ISO 18113-4:2009 also applies to information supplied by the manufacturer with calibrators and control materials intended for use with IVD medical devices for self-testing.ISO 18113-4:2009 can also be applied to accessories, where appropriate.ISO 18113-4:2009 applies to the labels for outer and immediate containers and to the instructions for use.

Committee
CEN/TC 140
DocumentType
Standard
PublisherName
Comite Europeen de Normalisation
Status
Withdrawn
Supersedes

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