Sampling procedures used for acceptance testing of in vitro diagnostic medical devices. Statistical aspects Ingestion-build-232773 Fundamentals and vocabulary

Fundamentals and vocabulary

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

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The test portion is placed between two acrylic plates under a specified pressure in a test device for 4 h at (37 ± 2) °C

Sampling procedures used for acceptance testing of in vitro diagnostic medical devices. Statistical aspects Ingestion-build-232773 Fundamentals and vocabularyBS 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