NEN-ISO 14708-5
Implants for surgery - Active implantable medical devices - Part 5: Circulatory support devices
active, Most Current
| Organization: | NEN |
| Publication Date: | 1 February 2010 |
| Status: | active |
| Page Count: | 56 |
| ICS Code (Implants for surgery, prosthetics and orthotics): | 11.040.40 |
scope:
This part of ISO 14708 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. This part of ISO 14708 specifies type tests, animal studies and clinical evaluation requirements.
Document History
NEN-ISO 14708-5
February 1, 2010
Implants for surgery - Active implantable medical devices - Part 5: Circulatory support devices
This part of ISO 14708 specifies requirements for safety and performance of active implantable circulatory support devices. It is not applicable to extracorporeal perfusion devices, cardiomyoplasty,...