SN EN ISO 13485:2003被替代
Medical Devices - Quality Management Systems - Requirements For Regulatory Purposes
出版：Swiss Standards
专家解读视频
Describes the 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 requirements and regulatory requirements applicable to medical devices and related services.
Supersedes SN EN ISO 13488. (09/2004) Supersedes SN EN 46003. (11/2007)
NF EN ISO 13485:2004 - Identical
I.S. EN ISO 13485:2003 - Identical
ONORM EN ISO 13485:2007 - Identical
ISO 13485:2003 - Identical
NBN EN ISO 13485:2012 - Identical
SS EN ISO 13485 Ed. 3 (2012) - Identical
NS EN ISO 13485:2012 - Identical
NEN EN ISO 13485:2012 - Identical
UNE EN ISO 13485:2012 - Identical
NF EN ISO 13485:2012 - Identical
NBN EN ISO 13485:2003 - Identical
NS EN ISO 13485:2003 - Identical
ONORM EN ISO 13485:2010 - Identical
BS EN ISO 13485:2003 - Identical
DIN EN ISO 13485 (2007-10) - Identical
UNI EN ISO 13485:2004 - Identical
UNE EN ISO 13485:2004 - Identical
SS EN ISO 13485:2003 - Identical
NEN EN ISO 13485:2003 - Identical
