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Publication details

Publication CODE Title
ISO 14971:2007 (2007-03) MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
 
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Description
ISO 14971:2007 specifies 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. The requirements of ISO 14971:2007 are applicable to all stages of the life-cycle of a medical device.
Class  C990  (IEC PUBLICATIONS IEC PUBLICATIONS)
Available files
EN version

FR version

Status
Status IEC PUBLICATION
Situation Withdrawn
Replaced by  ISO 14971:2019
Replaces  ISO 14971:2000
Replaces  ISO 14971:2000/AMD1:2003
Origin
Committee TC 62/SC 62A
COMMON ASPECTS OF ELECTRICAL EQUIPMENT USED IN MEDICAL PRACTICE
Responsible De heer VAN HECKE Luk
Approval
BEC Approval 2007-03-31
Registration 175580
NBN Status New
IEC publication date 2007-03-31
IEC file modification date 2017-02-16