SS EN 12442-1 Ed. 1 (2001)被替代
Animal Tissues And Their Derivatives Utilized In The Manufacture Of Medical Devices - Part 1: Analysis And Management Of Risk
出版：Standardiserings-Kommissionen I Sverige
專家解讀視頻
Applicable to medical devices (excluding in-vitro diagnostic medical devices) made using animal tissue or products derived from animal tissue which are or have been rendered non-viable. Specifies a procedure to investigate, using available information the safety of such devices by identifying hazards and estimating risks associated with the device (risk analysis).
BS EN 12442-1:2000 - Identical
DIN EN 12442-1 (2001-01) - Identical
SN EN 12442-1:2000 - Identical
ONORM EN 12442-1:2000 - Identical
NEN EN 12442-1:2000 - Identical
I.S. EN 12442-1:2000 - Identical
UNI EN 12442-1:2002 - Identical
NS EN 12442-1 Ed. 1 (2000) - Identical
UNE EN 12442-1:2001 - Identical
NF EN 12442-1:2000 - Identical
NBN EN 12442-1:2000 - Identical
