Standard Svensk standard · SS-EN 13975

In vitro-diagnostik - Statistisk acceptanskontroll för in vitro-diagnostiska medicintekniska produkter - Statistiska överväganden

Status: Gällande

Omfattning
This European Standard specifies sampling procedure requirements for acceptance testing of finished in vitro diagnostic medical devices, which require EC verification by a notified body. Two different provisions are addressed: a) verification by testing attributes and/or variables on a statistical basis; b) verification by testing a homogeneous batch which has been defined by appropriate means of process validation and in-process control. This standard specifies requirements and criteria for testing procedures to establish and verify the homogeneity of processes and products. This standard is also applicable for drawing up sampling plans for finished products according to the requirements laid down for manufacturers' product certification and production quality systems.

Ämnesområden

(11.100.10)


Produktinformation

Språk: Engelska

Framtagen av: Laboratoriemedicin, SIS/TK 331

Internationell titel: Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects

Artikelnummer: STD-34406

Utgåva: 1

Fastställd: 2003-08-01

Antal sidor: 13