Standard Swedish standard · SS-EN 13532

General requirements for in vitro diagnostic medical devices for self-testing

Status: Valid

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Standard Swedish standard · SS-EN 13532

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Scope

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.

Subjects

In vitro diagnostic test systems (11.100.10)

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General requirements for in vitro diagnostic medical devices for self-testing

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