Abstract

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.


General information 

  • Status
     : Withdrawn
    Publication date
     : 2010-02
  • Edition
     : 1
    Number of pages
     : 47
  • Technical Committee
     : ISO/TC 150/SC 6 Active implants
  • ICS
     :
    11.040.40 Implants for surgery, prosthetics and orthotics

Life cycle

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