SS-EN-591 › Instructions for use for in vitro diagnostic instruments for professional use
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This standard specifies the requirements for the contents of instructions for use for in vitro diagnostic instruments including apparatus, equipment, calibrators and control materials for professional use, hereafter called IVD instruments. NOTE 1 Instructions for use are essential to enable the safe and proper operation of IVD instruments. 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 591
Revision Level
EDITION 2
Status
Superseded
Publication Date
June 29, 2001
Language(s)
English
Page Count
12
International Equivalent
EN 591:2001(IDT)