BS EN 13532:2002
General requirements for in vitro diagnostic medical devices for self-testing

Standard No.

BS EN 13532:2002

Release Date

2002

Published By

British Standards Institution (BSI)

Latest

BS EN 13532:2002

Replace

99/563274 DC-1999

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.

BS EN 13532:2002 history

• 2002 BS EN 13532:2002 General requirements for in vitro diagnostic medical devices for self-testing