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ANSI/AAMI/ISO 14708-5:2010 (R2015)

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

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.

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Association for the Advancement of Medical Instrumentation [aami]

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