DIN EN 12442-1 (2001-01)被替代
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
出版：German Institute for Standardisation (Deutsches Institut für Normung)
专家解读视频
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).
SS EN 12442-1 Ed. 1 (2001) - Identical
NS EN 12442-1 Ed. 1 (2000) - Identical
I.S. EN 12442-1:2000 - Identical
UNI EN 12442-1:2002 - Identical
NBN EN 12442-1:2000 - Identical
NF EN 12442-1:2000 - Identical
ONORM EN 12442-1:2000 - Identical
BS EN 12442-1:2000 - Identical
SN EN 12442-1:2000 - Identical
UNE EN 12442-1:2001 - Identical
NEN EN 12442-1:2000 - Identical
