
Quality Systems - Medical Devices - Particular Requirements For The Application Of En Iso 9003
出版:Standardiserings-Kommissionen I Sverige

专家解读视频
Defines, in conjunction with EN ISO 9003:1994, the quality system requirements for the final inspection and test of medical devices excluding in vitro diagnostic medical devices and active implantable medical devices, and is applicable when a medical device supplier's quality system is assessed in accordance with regulatory requirements.
NEN EN 46003:1999 - Identical
UNE EN 46003:2000 - Identical
NS EN 46003 Ed. 1 (1999) - Identical
I.S. EN 46003:2000 - Identical
NF EN 46003:1999 - Identical
NBN EN 46003 Ed. 1 (2000) - Identical
DIN EN 46003 (1999-10) - Identical
BS EN 46003:1999 - Identical
SN EN 46003:1999 - Identical