<p>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.</p>
<p>ISO 14708-5:2010 specifies type tests, animal studies and clinical evaluation requirements.</p>
Registration number (WIID)
52779
Scope
<p>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.</p>
<p>ISO 14708-5:2010 specifies type tests, animal studies and clinical evaluation requirements.</p>
