ISO 13485:2016現(xiàn)行
Medical devices - Quality management systems - Requirements for regulatory purposes
出版：International Organization for Standardization
專家解讀視頻
Provides requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
DS EN ISO 13485 : 2016 COR 2016 - Identical
I.S. EN ISO 13485:2016 - Identical
OVE/ONORM EN ISO 13485 : 2017 - Identical
NBN EN ISO 13485 : 2016 - Identical
NEN EN ISO 13485 : 2016 C11 2017 - Identical
EN ISO 13485:2016 - Identical
BS EN ISO 13485 : 2016 - Identical
DS/EN ISO 13485:2016 - Identical
EN ISO 13485 : 2016 COR 2018 - Identical
UNE EN ISO 13485 : 2016 - Identical
AS ISO 13485-2003 - Identical
NBR ISO 13485 : 2016 - Identical
DS EN ISO 13485 : 2016 COR 2016 - Identical
NBR ISO 13485 : 2016 - Identical
CEI UNI EN ISO 13485 : 2012 - Identical
SS-EN ISO 13485:2016 - Identical
CSA ISO 13485 : 2016 - Identical
DS/EN ISO 13485:2016 - Identical
BIS IS/ISO 13485 : 2016 - Identical
BIS IS 15579 : 2005 - Identical
SANS 13485 : 1ED 2004(R2011) - Identical
OVE/ONORM EN ISO 13485 : 2017 - Identical
CSA PLUS 13485 : 2006 - Identical
PN EN ISO 13485 : 2016 - Identical
AS ISO 13485:2017 - Identical
I.S. EN ISO 13485:2016&LC:2016&AC:2018 - Identical
AAMI ISO 13485 : 2016 - Identical
EN ISO 13485:2016 - Identical
EN ISO 13485 : 2016 COR 2018 - Identical
GOST ISO 13485 : 2011 - Identical
CEI UNI EN ISO 13485 : 2012 - Identical
AAMI ISO 13485 : 2016 - Identical
SS-EN ISO 13485:2016 - Identical
SN EN ISO 13485 : 2016 - Identical
I.S. EN ISO 13485:2016&LC:2016&AC:2018 - Identical
PN EN ISO 13485 : 2016 - Identical
CSA ISO 13485 : 2016 - Identical
DIN EN ISO 13485 : 2016 - Identical
UNI CEI EN ISO 13485 : 2012 - Identical
NF EN ISO 13485 : 2016 - Identical
BIS IS/ISO 13485 : 2016 - Identical
DIN EN ISO 13485 E : 2016 - Identical
AS ISO 13485:2017 - Identical
