ÖNORM EN 12442-3

1.1 This Part of EN 12442 specifies requirements for the validation of elimination and/or inactivation of viruses and/or transmissible agents during the manufacture of medical devices (excluding in-vitro diagnostic medical devices) utilizing materials of animal origin. It is not applicable to bacteria, moulds and yeasts. NOTE 1: Analysis and management of risk and 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 extremely important (see EN 12442-1 and EN 12442-2). NOTE 2: EN 550, EN 552, EN 554, ISO 14160 and EN 1174 may be relevant for bacteria, moulds and yeast (see Bibliography). 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 (e.g. EN ISO 9001 and EN 46001 or EN ISO 9002 and EN 46002, see Bibliography) which may be used to control all stages of manufacture. It is not a requirement of this standard to apply a complete quality system during manufacture but certain elements of such a system are required and these are addressed at appropriate places in the text. 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.