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ISO 14708-5:2010

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 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.

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International Organization for Standardization [iso]

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