Sampling procedures used for acceptance testing of in vitro diagnostic medical devices. Statistical aspects Ingestion-build-232773 Annex A (informative) Associated IMS

Annex A (informative) Associated IMS specifications

Its scope is defined in terms of three dimensions: the types of assessment to which it applies

This Part contains:

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Sampling procedures used for acceptance testing of in vitro diagnostic medical devices. Statistical aspects Ingestion-build-232773 Annex A (informative) Associated IMSBS EN 13975: 2003 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 European