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 SN EN 1441 (01/2006)

SN EN 1441:1998

SN EN ISO 14971:2010

ONORM EN ISO 14971:2007 - Identical

DIN EN ISO 14971 (2007-07) - Identical

BS EN ISO 14971:2007 - Identical

UNI EN ISO 14971:2008 - Identical

NEN EN ISO 14971:2009 - Identical

UNE EN ISO 14971:2009 - 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

NEN EN ISO 14971:2007 - Identical

ISO 14971:2007 - Identical

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

UNE EN ISO 14971:2007 - Identical

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

I.S. EN ISO 14971:2007 - Identical

NF EN ISO 14971:2007 - Identical

NBN EN ISO 14971:2007 - Identical