ISO 14708-5:2010
Implants for surgery — Active implantable medical devices — Part 5: Circulatory support devices
Implants for surgery — Active implantable medical devices — Part 5: Circulatory support devices
Referenced standards
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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.
| Edition | 2010 |
|---|---|
| Standard Part No | 5 |
| Published Date | 2010 |
| Published By | International Standardization Organisation |
| Page Count | 47 |