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ISO 14708-5:2010
M00000054
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ISO 14708-5:2010 Implants for surgery - Active implantable medical devices - Part 5: Circulatory support devices
standard by International Organization for Standardization, 02/01/2010
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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.