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)

NEN EN 1441:1997

NEN EN ISO 14971:2007

UNE EN ISO 14971:2009 - Identical

NF EN ISO 14971:2009 - Identical

NBN EN ISO 14971:2009 - Identical

NS EN ISO 14971:2009 - Identical

NBN EN ISO 14971:2012 - Identical

SS EN ISO 14971 Ed. 4 (2012) - Identical

SN EN ISO 14971:2012 - Identical

UNE EN ISO 14971:2012 - Identical

NS EN ISO 14971:2012 - Identical

NF EN ISO 14971:2013 - Identical

ONORM EN ISO 14971:2013 - Identical

DIN EN ISO 14971 (2013-04) - Identical

I.S. EN ISO 14971:2012 - Identical

BS EN ISO 14971:2012 - 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

UNI EN ISO 14971:2008 - Identical

SS EN ISO 14971 Ed. 2 (2007) - Identical

UNE EN ISO 14971:2007 - Identical

NS EN ISO 14971 Ed. 2 (2007) - Identical

NF EN ISO 14971:2007 - Identical

NBN EN ISO 14971:2007 - Identical