ONORM EN ISO 13485:2007被替代
Medical Devices - Quality Management Systems - Requirements For Regulatory Purposes
出版：Osterreichisches Normungsinstitut
專家解讀視頻
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 OVE/ONORM EN ISO 13485 and OVE/ONORM EN ISO 13488. (12/2003) Supersedes ONORM EN 46001 and ONORM EN 46002 (03/2006)
ISO 13485:2003 - Identical
NEN EN ISO 13485:2003 - Identical
SS EN ISO 13485:2003 - Identical
SN EN ISO 13485:2003 - Identical
BS EN ISO 13485:2003 - Identical
DIN EN ISO 13485 (2007-10) - Identical
NF EN ISO 13485:2004 - Identical
NBN EN ISO 13485:2003 - Identical
UNI EN ISO 13485:2004 - Identical
I.S. EN ISO 13485:2003 - Identical
NS EN ISO 13485:2003 - Identical
UNE EN ISO 13485:2004 - Identical
