1126325

AAMI/ISO 14971:2000/A1:2003

Medical Devices - Application of Risk Management to Medical Devices

standard by Association for the Advancement of Medical Instrumentation/International Org. for Standardization, 08/26/2003

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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.

Includes Amendment 1, Rationale for Requirements, June 2003.
 

Product Details

Published:
08/26/2003
ISBN(s):
1570201498
ANSI:
ANSI Approved
Number of Pages:
57
File Size:
1 file , 250 KB
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


    Medical Devices - Application of Risk Management to Medical Devices

    • Historical Version

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

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    Medical Devices - Application of Risk Management to Medical Devices

    • Historical Version

  4. AAMI 14971


    Risk management- Part 1: Application of risk management

    • Historical Version