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AAMI/ISO 14708-5:2010/(R)2015 [ Withdrawn ]

Implants for surgery - Active implantable medical devices - Part 5: Circulatory support devices

standard by Association for the Advancement of Medical Instrumentation/International Org. for Standardization , 04/01/2010

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Full Description

AAMI/ISO 14708-5 specifies requirements for safety and performance of active implantable circulatory support devices. Excluded from this scope are intra-aortic balloon pumps, external corporeal perfusion devices and cardiomyplasty. This standard specifies type tests, animal studies and clinical evaluation requirements that are to be carried out to show compliance with this standard.
 

Product Details

Published:
04/01/2010
ISBN(s):
1570203784
ANSI:
ANSI Approved
Number of Pages:
62
File Size:
1 file , 470 KB
Same As:
ISO 14708-5:2010
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This product is unavailable in Ukraine, Russia, Belarus
 

Document History

  1. AAMI/ISO 14708-5:2010/(R)2015

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    Implants for surgery - Active implantable medical devices - Part 5: Circulatory support devices

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  2. AAMI TIR26:2000


    Ventricular assist and heart replacement systems

    • Historical Version