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).