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About This Item

 

Full Description

Specifies a process for a manufacturer to identify the hazards and hazardous situations associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the resulting risks, to control these risks, and to monitor the effectiveness of that control. This standard does not specify acceptable risk levels.
 

Document History

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

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    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


    Risk management- Part 1: Application of risk management

    • Historical Version