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AAMI/ISO 14971:2019

Medical devices - Application of risk management to medical devices

standard by Association for the Advancement of Medical Instrumentation/International Org. for Standardization, 05/01/2019

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Full Description

Valuable checklist also available to assist with compliance to this standard.

Specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.
 

Product Details

Published:
05/01/2019
ISBN(s):
9781570207181
ANSI:
ANSI Approved
Number of Pages:
49
File Size:
1 file , 720 KB
Note:
This product is unavailable in Ukraine, Russia, Belarus
 

Document History

  1. AAMI/ISO 14971:2019

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    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


    Risk management- Part 1: Application of risk management

    • Historical Version