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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.
Reģistrācijas numurs (WIID)
5109
Darbības sfēra
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.
