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EVS-EN ISO 18113-2:2010

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use

General information
Withdrawn from 02.11.2011
Base Documents
ISO 18113-2:2009; EN ISO 18113-2:2009
Directives or regulations
None
Standard history
Status
Date
Type
Name
02.11.2011
Main
Main
EVS-EN 375:2001
This part of ISO 18113 specifies requirements for information supplied by the manufacturer of IVD reagents for professional use. This part of ISO 18113 also applies to information supplied by the manufacturer with calibrators and control materials intended for use with IVD medical devices for professional use. This part of ISO 18113 can also be applied to accessories. This part of ISO 18113 applies to the labels for outer and immediate containers and to the instructions for use. This part of ISO 18113 does not apply to a) IVD instruments or equipment, b) IVD reagents for self-testing.
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Standard monitoring