DSF/ISO 14708-5
Implants for surgery -- Active implantable medical devices-- Part 5: Circulatory support devices
inactive
| Organization: | DS |
| Status: | inactive |
| Page Count: | 55 |
| ICS Code (Implants for surgery, prosthetics and orthotics): | 11.040.40 |
scope:
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 History
May 6, 2022
Implants for surgery – Active implantable medical devices – Part 5: Circulatory support devices
This document specifies requirements for safety and performance of active implantable circulatory support devices, including type tests, animal studies and clinical evaluation requirements. NOTE –...
September 15, 2015
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...
DSF/ISO 14708-5
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...