SS-EN-13532 › General requirements for in vitro diagnostic medical devices for self-testing
SS-EN-13532
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EDITION 1
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CURRENT
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This European Standard specifies general requirements for in vitro diagnostic medical devices (IVD MDs) for self-testing in order to ensure that IVD MDs for self-testing are safe and suitable for the purposes as specified by the manufacturer. This standard does not address medical aspects of IVD MDs for self-testing.
To find similar documents by classification:
11.100.10 (In vitro diagnostic test systems)
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Designation Name
SS-EN 13532
Revision Level
EDITION 1
Status
Current
Publication Date
April 17, 2003
Language(s)
English
Page Count
9
International Equivalent
EN 13532:2002(IDT)