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EVS-EN ISO 18113-3:2010

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

General information
Withdrawn from 02.11.2011
Base Documents
ISO 18113-3:2009; EN ISO 18113-3:2009
Directives or regulations
None
Standard history
Status
Date
Type
Name
02.11.2011
Main
Main
EVS-EN 591:2001
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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Standard monitoring
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