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ISO 14708-5:2010

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ISO 14708-5:2010

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

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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.

Author ISO/TC 150/SC 6 Active implants
Editor ISO
Document type Standard
Format Paper
Edition 1
ICS 11.040.40 : Implants for surgery, prosthetics and orthotics
Number of pages 47
Weight(kg.) 0.1799
Year 2010
Country Switzerland