99.60 Withdrawal effective Dec 15, 2007
CEN
CEN/TC 316 Medical products utilizing cells, tissues and/or their derivatives
European Norm
11.120.01 Pharmaceutics in general
This part of EN 12442 applies to medical devices (excluding in-vitro diagnostic medical devices) manufactured utilizing animal tissue or products derived from animal tissue, which are 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 estimating the risks associated with the device (risk analysis).
Legislation related to this standard
WITHDRAWN
EN 12442-1:2000
99.60
Withdrawal effective
Dec 15, 2007
WITHDRAWN
EN ISO 22442-1:2007