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About This Item

 

Full Description

This American National Standard specifies a procedure by which a manufacturer can identify the hazards associated with medical devices and their accessories (including in vitro diagnostic medical devices), estimate and evaluate the risks, control these risks, and monitor the effectiveness of the control.
 

Document History

  1. AAMI/ISO 14971:2007/(R)2016


    Medical Devices - Application of Risk Management to Medical Devices

    • Most Recent
  2. AAMI/ISO 14971:2000/A1:2003


    Medical Devices - Application of Risk Management to Medical Devices

    • Historical Version
  3. AAMI 14971

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    Risk management- Part 1: Application of risk management

    • Historical Version