ÖNORM EN 12442-2

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. 1.2 This Part of EN 12442 does not cover the utilization of human tissues in medical devices. 1.3 This Part of EN 12442 does not describe a quality assurance system for the control of all stages of manufacture. NOTE: Attention is drawn to the standards for quality systems (see EN ISO 9001 and EN 46001 or EN ISO 9002 and EN 46002) which relate to all stages of manufacture. It is not a requirement of this standard to have a complete quality system during manufacture but certain elements of such a system are required. 1.4 This Part of EN 12442 does not consider the effect of any method of elimination and/or inactivation on the suitability of the medical device for its intended use.