SS-EN-592 › Instructions for use for in vitro diagnostic instruments for self-testing
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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.
To find similar documents by classification:
11.100.10 (In vitro diagnostic test systems)
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Designation Name
SS-EN 592
Revision Level
EDITION 2
Status
Superseded
Publication Date
July 26, 2002
Language(s)
English
Page Count
11
International Equivalent
EN 592:2002(IDT)