BS EN 13532:2002

This standard BS EN 13532:2002 General requirements for in vitro diagnostic medical devices for self-testing is classified in these ICS categories:

• 11.100.10 In vitro diagnostic test systems

This 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.