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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 |