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Norm

ÖNORM EN 376

Issue date: 2002 05 01

Information supplied by the manufacturer with in vitro diagnostic reagents for self-testing

This European Standard specifies the requirements for the information supplied by the manufacturer of in vitro diagnostic reagents for use in self-testing including reag...
Withdrawn: 2010 04 15
§ Legal References
Publisher:
Austrian Standards International
Format:
Digital | 14 Pages
Language:
German | English
Optionally co-design standards:
This European Standard specifies the requirements for the information supplied by the manufacturer of in vitro diagnostic reagents for use in self-testing including reagent products, calibrators, control materials and kits, which hereafter are called IVD reagents. NOTE This standard can also be applied to accessories.
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ÖNORM EN ISO 18113-4
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ÖNORM EN ISO 18113-4
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ÖNORM EN 376
2002 05 01
Information supplied by the manufacturer with in vitro diagnostic reagents for self-testing
Norm
ÖNORM EN 376
1993 03 01
In vitro diagnostic systems - Requirements for labelling of in vitro diagnostic reagents for self-te...
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Norm
ISO 1000:1992
Issue date : 1992 11 12
SI units and recommendations for the use of their multiples and of certain other units
Norm
ÖNORM EN ISO 18113-4
Issue date : 2010 04 15
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009)