Sampling procedures used for acceptance testing of in vitro diagnostic medical devices. Statistical aspects Ingestion-build-115288 BS EN ISO 10722 describes

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Sampling procedures used for acceptance testing of in vitro diagnostic medical devices. Statistical aspects Ingestion-build-115288 BS EN ISO 10722 describesBS 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