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AAMI/ISO 14971:2007/(R)2016

Medical Devices - Application of Risk Management to Medical Devices

standard by Association for the Advancement of Medical Instrumentation/International Org. for Standardization, 04/23/2007

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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.
 

Product Details

Published:
04/23/2007
ANSI:
ANSI Approved
Number of Pages:
86
File Size:
1 file , 1.8 MB
Same As:
ISO 14971:2007
Note:
This product is unavailable in Ukraine, Russia, Belarus
 

Document History

  1. AAMI/ISO 14971:2019


    Medical devices - Application of risk management to medical devices

    • Most Recent

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

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    Medical Devices - Application of Risk Management to Medical Devices

    • Historical Version

  3. AAMI/ISO 14971:2000/A1:2003


    Medical Devices - Application of Risk Management to Medical Devices

    • Historical Version

  4. AAMI 14971


    Risk management- Part 1: Application of risk management

    • Historical Version