I.S. EN 46001:1997被替代
Quality Systems - Medical Devices - Particular Requirements for the Application of en iso 9001
出版：National Standards Authority of Ireland
专家解读视频
Specifies the quality system requirements for the design/development, production, and where relevant, installation and servicing of medical devices.
To be used in conjunction with I.S. EN ISO 9001.
(02/2002)
UNE EN 46001:1996 - Identical
NF EN 46001:1996 - Identical
BS EN 46001:1997 - Identical
ONORM EN 46001:1996 - Identical
DIN EN 46001 (1996-09) - Identical
SN EN 46001:1997 - Identical
SS EN 46001 Ed. 2 (1997) - Identical
