NF EN ISO 13485:2004被替代
Medical Devices - Quality Management Systems - Requirements For Regulatory Purposes
出版：Association Francaise de Normalisation
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.
Indice de classement: S99-101. PR NF EN ISO 13485 May 2003 (05/2003) Supersedes NFS 99 101. (02/2004) Supersedes NF EN 46001 and NF EN ISO 13488. (10/2007)
ONORM EN ISO 13485:2007 - Identical
NS EN ISO 13485:2003 - Identical
I.S. EN ISO 13485:2003 - Identical
UNI EN ISO 13485:2004 - Identical
NBN EN ISO 13485:2003 - Identical
DIN EN ISO 13485 (2007-10) - Identical
BS EN ISO 13485:2003 - Identical
SN EN ISO 13485:2003 - Identical
DIN EN ISO 13485 (2010-01) - Identical
ONORM EN ISO 13485:2010 - Identical
I.S. EN ISO 13485:2012 - Identical
BS EN ISO 13485:2012 - Identical
NEN EN ISO 13485:2012 - Identical
SS EN ISO 13485 Ed. 3 (2012) - Identical
UNE EN ISO 13485:2012 - Identical
NBN EN ISO 13485:2012 - Identical
NS EN ISO 13485:2012 - Identical
UNE EN ISO 13485:2004 - Identical
SS EN ISO 13485:2003 - Identical
NEN EN ISO 13485:2003 - Identical
ISO 13485:2003 - Identical
