Historical
DIN EN 12442-3:2001
Animal tissue and their derivatives utilized in the manufacture of medical devices - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible agents; English version of DIN EN 12442-3 (FOREIGN STANDARD)
The document specifies requirements for the validation of elimination and/or inactivation of viruses and/or transmissible agents during the manufacture of medical devices incorporating materials of animal origin. It is not applicable to bacteria, moulds and yeasts. Note 1: Conventional methods used for sterilization, when used for the treatment of animal tissues for medical devices, have not been shown to be completely effective in inactivating th causative agents of spongiform encephalopathies. Selective sourcing is consequently of great importance.
CONTENT PROVIDER
Deutsches Institut für Normung [din]
Deutsches Institut für Normung [din]