
Quality Systems - Medical Devices - Particular Requirements For The Application Of En Iso 9002
出版:Standardiserings-Kommissionen I Sverige

专家解读视频
Specifies in conjunction with ISO 9002, the quality system requirements for the production, installation and servicing of medical devices when relevant. It applies when there is a need to assess a medical device supplier's quality system.
Supersedes SS EN 46002 (07/2006)
ISO 13488:1996 - Identical
NEN EN ISO 13488:2000 - Identical
UNE EN ISO 13488:2001 - Identical
NS EN ISO 13488 Ed. 1 (2001) - Identical
NF EN ISO 13488:2001 - Identical
SN EN ISO 13488:2001 - Identical
I.S. EN ISO 13488:2000 - Identical
DIN EN ISO 13488 (2001-02) - Identical
BS EN ISO 13488:2001 - Identical