DSF/FPREN ISO 14708-5
Implants for surgery – Active implantable medical devices – Part 5: Circulatory support devices (ISO/FDIS 14708-5:2020)
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| Organization: | DS |
| Status: | active |
| Page Count: | 90 |
| 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
October 18, 2022
Implants for surgery – Active implantable medical devices – Part 5: Circulatory support devices (ISO 14708-5:2020)
This document specifies requirements for safety and performance of active implantable circulatory support devices, including type tests, animal studies and clinical evaluation requirements. NOTE –...
DSF/FPREN ISO 14708-5
Implants for surgery – Active implantable medical devices – Part 5: Circulatory support devices (ISO/FDIS 14708-5:2020)
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...
Implants for surgery – Active implantable medical devices – Part 5: Circulatory support devices (ISO/DIS 14708-5:2019)
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...