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Norm

ÖNORM EN 592

Issue date: 2002 05 01

Instructions for use for in vitro diagnostic instruments for self-testing

This European Standard specifies the requirements for the contents of instructions for use for in vitro diagnostic instruments including apparatus and equipment for self-...
Withdrawn: 2010 04 15
§ Legal References
Publisher:
Austrian Standards International
Format:
Digital | 11 Pages
Language:
German | English
Optionally co-design standards:
This European Standard specifies the requirements for the contents of instructions for use for in vitro diagnostic instruments including apparatus and equipment for self-testing which hereafter are called IVD instruments. NOTE 1 Instructions for use are essential to enable the safe and proper operation of IVD instruments by lay persons. NOTE 2 This standard can also be applied to accessories. This standard is not applicable to field repair instructions.
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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
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ÖNORM EN ISO 18113-5
Issue date : 2010 04 15
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009)