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ISO 14708-5:2010

Implants for surgery — Active implantable medical devices — Part 5: Circulatory support devices

Standard Details

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Status : WITHDRAWN
Standard Type: Main
Document No: ISO 14708-5:2010
Document Year: 2010
Pages: 47
Edition: 1
  • ICS:
  • 11.040.40 Implants for surgery, prosthetics and orthotics

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WITHDRAWN
ISO 14708-5:2010
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