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ISO 14971:2007

Medical devices — Application of risk management to medical devices

Standard Details

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.

General Information

Status : WITHDRAWN
Standard Type: Main
Document No: ISO 14971:2007
Document Year: 2007
Pages: 82
Edition: 2
  • Section Volume:
  • ISO/TC 210. Quality management and corresponding general aspects for medical devices

Life Cycle

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WITHDRAWN
ISO 14971:2007
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