Sampling procedures used for acceptance testing of in vitro diagnostic medical devices. Statistical aspects Ingestion-build-232773 The test portion is placed

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

This Part contains:

Fundamentals and vocabulary

Annex A (informative) Associated IMS specifications

This European Standard establishes a system of strength classes for general use in structural codes

Sampling procedures used for acceptance testing of in vitro diagnostic medical devices. Statistical aspects Ingestion-build-232773 The test portion is placedBS 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