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  • Status :  Withdrawn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
  • :
    ISO/TC 150/SC 6
    Active implants
  • 11.040.40
    Implants for surgery, prosthetics and orthotics

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