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ANSI/AAMI/ISO 14708-5:2010

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

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. Specifies type tests, animal studies and clinical evaluation requirements.

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Association for the Advancement of Medical Instrumentation [aami]

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