ISO-14971 › Historical Revision Information
Medical devices - Application of risk management to medical devices
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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.
To find similar documents by classification:
11.040.01 (Medical equipment in general)
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Document Number
ISO-14971
Revision Level
2ND EDITION
Status
Superseded
Publication Date
March 1, 2007
Committee Number
ISO/TC 210