Standard Svensk standard · SS-EN 13532

In vitro-diagnostik - Allmänna krav för in vitro-diagnostiska medicintekniska produkter för självtestning

Status: Gällande

Omfattning
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.

Ämnesområden

(11.100.10)


Produktinformation

Språk: Engelska

Framtagen av: Laboratoriemedicin, SIS/TK 331

Internationell titel: General requirements for in vitro diagnostic medical devices for self-testing

Artikelnummer: STD-33975

Utgåva: 1

Fastställd: 2003-04-17

Antal sidor: 9