
Animal Tissues And Their Derivatives Utilized In The Manufacture Of Medical Devices - Part 1: Analysis And Management Of Risk
出版:Nederlands Normalisatie Instituut

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).
To be used in conjunction with EN 1441. (09/2002)
UNI EN 12442-1:2002 - Identical
NBN EN 12442-1:2000 - Identical
NF EN 12442-1:2000 - Identical
ONORM EN 12442-1:2000 - Identical
DIN EN 12442-1 (2001-01) - Identical
BS EN 12442-1:2000 - Identical
SN EN 12442-1:2000 - Identical
I.S. EN 12442-1:2000 - Identical
NS EN 12442-1 Ed. 1 (2000) - Identical
UNE EN 12442-1:2001 - Identical
SS EN 12442-1 Ed. 1 (2001) - Identical