
Quality systems - Medical devices - Particular requirements for the application of ISO 9002
出版:International Organization for Standardization

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.
NBR ISO 13488 : 2000 - Identical
AS ISO 13488-2002 - Identical
CEI UNI EN ISO 13488 : 3ED 2002 - Identical
DIN EN ISO 13488 : 2001 - Identical
CSA ISO 13488 : 0 - Identical
DIN EN ISO 13488 E : 2001 - Identical
BS EN ISO 13488 : 2001 - Identical
UNI CEI EN ISO 13488 : 2002 - Identical
AAMI ISO 13488 : 1996 - Identical
I.S. EN ISO 13488:2000 - Identical
KS P ISO 13488:2007 - Identical
UNE EN ISO 13488:2001 - Identical
OVE/ONORM EN ISO 13488:2001 - Identical
NF EN ISO 13488:2001 - Identical
UNI CEI EN ISO 13488:2002 - Identical
I.S. EN ISO 13488:2000 - Identical
CSA ISO 13488:1998 (R2001) - Identical
NS EN ISO 13488 Ed. 1 (2001) - Identical
SS EN ISO 13488 Ed. 1 (2001) - Identical
AS ISO 13488-2002 - Identical
AAMI ISO 13488:1996 - Identical
NEN EN ISO 13488:2000 - Identical
JIS Q 13488:1998 - Identical
DIN EN ISO 13488 (2001-02) - Identical
BS EN ISO 13488:2001 - Identical
CEI UNI EN ISO 13488 Ed. 3 (2002) - Identical
SN EN ISO 13488:2001 - Identical
NBR ISO 13488:2000 - Identical