Reference number
ISO 14971:2007
© ISO 2024
ISO 14971:2007
Medical devices — Application of risk management to medical devices
Edition 2
2007-03
Withdrawn
Withdrawn (Edition 2, 2007)

Abstract

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     : Withdrawn
    Publication date
     : 2007-03
    Corrected version (en)
     : 2007-09
    Corrected version (fr)
     : 2007-09
    Stage
    : Withdrawal of International Standard [95.99]
  • Edition
     : 2
    Number of pages
     : 82
  • Technical Committee :
    ISO/TC 210
    ICS :
    11.040.01 
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Life cycle

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