UNE EN ISO 14971:2009被替代
Medical Devices - Application Of Risk Management To Medical Devices
出版：Asociacion Espanola de Normalizacion
专家解读视频
Describes 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 UNE EN 1441. (04/2004) 2007 Edition is still active. (12/2009)
UNI EN ISO 14971:2008 - Identical
BS EN ISO 14971:2009 - Identical
I.S. EN ISO 14971:2009 - Identical
NEN EN ISO 14971:2009 - Identical
DIN EN ISO 14971 (2009-10) - Identical
NF EN ISO 14971:2009 - Identical
NBN EN ISO 14971:2009 - Identical
NS EN ISO 14971:2009 - Identical
SS EN ISO 14971 Ed. 3 (2009) - Identical
ONORM EN ISO 14971:2009 - Identical
SN EN ISO 14971:2010 - Identical
ONORM EN ISO 14971:2007 - Identical
SN EN ISO 14971:2007 - Identical
SN EN ISO 14971:2012 - Identical
SS EN ISO 14971 Ed. 4 (2012) - Identical
NBN EN ISO 14971:2012 - Identical
