Historical
DIN EN 12442-1:2001
Animal tissues and their derivatives utilized in the manufacture of medical devices - Part 1: Analysis and management of risk; English version of DIN EN 12442-1 (FOREIGN STANDARD)
The document applies to medical devices (excluding in-vitro diagnostic medical devices) manufactured utilizing animal tissue or products derived from animal tissue, non-viable or rendered non-viable. It specifies, in conjunction with EN 1441, a procedure to investigate, using available information, the safety of such devices by identifying hazards and estimates the risks associated with the device (risk analysis). It is of particular assistance in areas where appropriate harmonized standards are not available or not used.
CONTENT PROVIDER
Deutsches Institut für Normung [din]
Deutsches Institut für Normung [din]