Implantater til kirurgi, proteser og ortopediske hjelpemidler

Komité: CEN/CLC/JTC 16 (CEN/CENELEC Joint Technical Committee on Active Implantable Medical Devices)
Sluttdato: 12. mar 2019
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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.