1.1 This Part of EN 12442 specifies requirements for controls on the sourcing, collection and handling (which includes storage and transport) of animals and tissues for the manufacture of medical devices utilizing materials of animal origin other than in vitro diagnostic medical devices.
NOTE 1: Requirements for the risk analysis of the use of materials of animal origin in medical devices are described in EN 12442-1.
NOTE 2: Conventional processes used for sterilization, when used for the treatment of animal tissues for medical devices, have not been shown to be completely effective in inactivating the causative agents of spongiform encephalopathies. Selective sourcing is thus extremely important. Manufacturers should refer to EN 12442-3 for information on the validation of the elimination and/or inactivation of viruses and transmissible agents.