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 published on: 2010-02-01 Edition: 1 (Monolingual) ICS: 11.040.40 Status: Published Stage: 90.20 (2015-01-15) TC/SC: ISO/TC 150/SC 6 Number of Pages: 47
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