24802

AAMI/ISO 13485:1996

Quality systems - Medical devices - Particular requirements for the application of ISO 9001

standard by Association for the Advancement of Medical Instrumentation/International Org. for Standardization , 12/15/1996

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Full Description

This International Standard specifies, in conjunction with ISO 9001, the quality system requirements for the design/development, production and, when relevant, installation and servicing of medical devices.
 

Product Details

Published:
12/15/1996
ANSI:
ANSI Approved
Number of Pages:
10
File Size:
1 file , 120 KB
Note:
This product is unavailable in Ukraine, Russia, Belarus
 

Document History

  1. AAMI/ISO 13485:2016/(R)2019


    Medical devices - Quality management systems - Requirements for regulatory purposes

    • Most Recent

  2. AAMI/ISO 13485:2003/(R)2009


    Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes

    • Historical Version

  3. AAMI/ISO 13485:1996

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    Quality systems - Medical devices - Particular requirements for the application of ISO 9001

    • Historical Version