
Quality Systems - Medical Devices - Particular Requirements For The Application Of En Iso 9002
出版:Asociacion Espanola de Normalizacion

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 UNE-EN 46002. (08/2003)
ISO 13488:1996 - Identical
NEN EN ISO 13488:2000 - Identical
SS EN ISO 13488 Ed. 1 (2001) - Identical
SN EN ISO 13488:2001 - Identical
NS EN ISO 13488 Ed. 1 (2001) - Identical
I.S. EN ISO 13488:2000 - Identical
NF EN ISO 13488:2001 - Identical
DIN EN ISO 13488 (2001-02) - Identical
BS EN ISO 13488:2001 - Identical