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.
Document identifier
ISO 14708-5:2010
Title
Implants for surgery - Active implantable medical devices - Part 5: Circulatory support devices
ISO Category
TC 150/SC 6: Active implants
Publication date
2010-02-01
International Relationship
AAMI/ISO 14708-5:2010/(R)2015
| Price |
185 vnd |
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