Abstract
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.
General information
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Status: WithdrawnPublication date: 2010-02Stage: Withdrawal of International Standard [95.99]
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Edition: 1Number of pages: 47
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Technical Committee :ISO/TC 150/SC 6ICS :11.040.40
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Life cycle
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Now
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Revised by
PublishedISO 14708-5:2020