NS EN ISO 14971:2012現行
Medical Devices - Application Of Risk Management To Medical Devices (Iso 14971:2007, Corrected Version 2007-10-01)
出版：Norwegian Standards (Norges Standardiseringsforbund)
專家解讀視頻
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 NS EN 1441. (11/2006)
NEN EN ISO 14971 : 2007 + COR 2012 - Identical
EN ISO 14971 : 2012 - Identical
ISO 14971 : 2007(R2010) - Identical
BS EN ISO 14971 : 2012 - Identical
EN ISO 14971:2012 - Identical
ONORM EN ISO 14971:2013 - Identical
NF EN ISO 14971:2013 - Identical
UNI EN ISO 14971:2008 - Identical
ONORM EN ISO 14971:2009 - 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
BS EN ISO 14971:2012 - Identical
I.S. EN ISO 14971:2012 - Identical
NF EN ISO 14971:2009 - Identical
DIN EN ISO 14971 (2009-10) - Identical
NEN EN ISO 14971:2009 - Identical
