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EVS-EN ISO 18113-3:2011

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009)

General information

Withdrawn from 01.07.2024
Base Documents
ISO 18113-3:2009; EN ISO 18113-3:2011
Directives or regulations
None

Standard history

Status
Date
Type
Name
01.07.2024
Main
02.11.2011
Main
Main
EVS-EN ISO 18113-3:2010
This part of ISO 18113 specifies requirements for information supplied by the manufacturer of IVD instruments for professional use. This part of ISO 18113 also applies to apparatus and equipment intended to be used with IVD instruments for professional use. This part of ISO 18113 can also be applied to accessories. This part of ISO 18113 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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