885619

AAMI 14971

Risk management- Part 1: Application of risk management

standard by Association for the Advancement of Medical Instrumentation, 10/16/2000

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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.
 

Product Details

Published:
10/16/2000
ANSI:
ANSI Approved
Number of Pages:
41
File Size:
1 file , 190 KB
Note:
This product is unavailable in Russia, Ukraine, 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


    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

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    Risk management- Part 1: Application of risk management

    • Historical Version