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.
NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.
WITHDRAWN
SRPS EN 13532:2008
95.99
Withdrawal of Standard
Oct 31, 2014
PUBLISHED
SRPS EN 13532:2014