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DS/ISO 14708-5

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

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Organization: DS
Publication Date: 15 September 2015
Status: inactive
Page Count: 56
ICS Code (Implants for surgery, prosthetics and orthotics): 11.040.40
scope:

ISO 14708-5:2010 specifies requirements for safety and performance of active implantable circulatory support devices. It is not applicable to extracorporeal perfusion devices, cardiomyoplasty, heart restraint devices and counter-pulsation devices, such as extra- or intra-aortic balloon pumps. ISO 14708-5:2010 specifies type tests, animal studies and clinical evaluation requirements.

Document History

May 6, 2022
Implants for surgery – Active implantable medical devices – Part 5: Circulatory support devices
This document specifies requirements for safety and performance of active implantable circulatory support devices, including type tests, animal studies and clinical evaluation requirements. NOTE –...
DS/ISO 14708-5
September 15, 2015
Implants for surgery – Active implantable medical devices – Part 5: Circulatory support devices
ISO 14708-5:2010 specifies requirements for safety and performance of active implantable circulatory support devices. It is not applicable to extracorporeal perfusion devices, cardiomyoplasty, heart...
Implants for surgery -- Active implantable medical devices-- Part 5: Circulatory support devices
ISO 14708-5:2010 specifies requirements for safety and performance of active implantable circulatory support devices. It is not applicable to extracorporeal perfusion devices, cardiomyoplasty, heart...
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