Norm

NEN-ISO 14708-5:2010 en

Chirurgische implantaten - Actieve implanteerbare medische hulpmiddelen - Deel 5: Circulerende steun hulpmiddelen

143,10

Over deze norm

Status Definitief
Aantal pagina's 47
Commissie Chirurgische implantaten
Gepubliceerd op 01-02-2010
Taal Engels
This part of ISO 14708 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. This part of ISO 14708 specifies type tests, animal studies and clinical evaluation requirements.

Details

ICS-code 11.040.40
Nederlandse titel Chirurgische implantaten - Actieve implanteerbare medische hulpmiddelen - Deel 5: Circulerende steun hulpmiddelen
Engelse titel Implants for surgery - Active implantable medical devices - Part 5: Circulatory support devices

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