NEN EN ISO 14971:2009现行
Medical Devices - Application Of Risk Management To Medical Devices
出版：Nederlands Normalisatie Instituut
专家解读视频
Defines a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.
Supersedes NEN EN 1441 (04/2003) 2007 version corrected and reprinted in March 2009. (10/2009)
NBN EN ISO 14971:2007 - Identical
NF EN ISO 14971:2007 - Identical
NS EN ISO 14971 Ed. 2 (2007) - Identical
UNE EN ISO 14971:2007 - Identical
SS EN ISO 14971 Ed. 2 (2007) - Identical
UNI EN ISO 14971:2008 - Identical
SN EN ISO 14971:2007 - Identical
ONORM EN ISO 14971:2007 - Identical
SN EN ISO 14971:2010 - Identical
ONORM EN ISO 14971:2009 - Identical
SS EN ISO 14971 Ed. 3 (2009) - Identical
BS EN ISO 14971:2012 - Identical
I.S. EN ISO 14971:2012 - Identical
DIN EN ISO 14971 (2013-04) - Identical
ONORM EN ISO 14971:2013 - Identical
NF EN ISO 14971:2013 - Identical
NS EN ISO 14971:2012 - Identical
UNE EN ISO 14971:2012 - Identical
SN EN ISO 14971:2012 - Identical
SS EN ISO 14971 Ed. 4 (2012) - Identical
NBN EN ISO 14971:2012 - Identical
NS EN ISO 14971:2009 - Identical
NBN EN ISO 14971:2009 - Identical
NF EN ISO 14971:2009 - Identical
UNE EN ISO 14971:2009 - Identical
