90.93 Standard confirmed Feb 20, 2020
CEN
CEN/TC 140 In vitro diagnostic medical devices
European Norm
11.100 Laboratory medicine
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.
Legislation related to this standard
PUBLISHED
EN 13532:2002
90.93
Standard confirmed
Feb 20, 2020