Norm

NEN-ISO 14708-6:2010 en

Chirurgische implantaten - Actieve implanteerbare medische hulpmiddelen - Deel 6: Speciale eisen voor actieve implanteerbare medische hulpmiddelen bestemd voor de behandeling van tachyarrhytmia (inclusief implanteerbare defibrillatoren)

179,33

Over deze norm

Status Definitief
Aantal pagina's 110
Commissie Chirurgische implantaten
Gepubliceerd op 01-03-2010
Taal Engels
This part of ISO 14708 specifies requirements that are applicable to IMPLANTABLE CARDIOVERTER DEFIBRILLATORS and the functions of ACTIVE IMPLANTABLE MEDICAL DEVICES intended to treat tachyarrhythmia. The tests that are specified in ISO 14708 are type tests and are to be carried out on samples of a device to show compliance. This part of ISO 14708 is also applicable to some non-implantable parts and accessories of the devices. The characteristics of the IMPLANTABLE PULSE GENERATOR or LEAD shall be determined by either the appropriate method detailed in this part of ISO 14708 or by any other method demonstrated to have accuracy equal to, or better than, the method specified. In the case of dispute, the method detailed in this part of ISO 14708 shall apply.

Details

ICS-code 11.040.40
Nederlandse titel Chirurgische implantaten - Actieve implanteerbare medische hulpmiddelen - Deel 6: Speciale eisen voor actieve implanteerbare medische hulpmiddelen bestemd voor de behandeling van tachyarrhytmia (inclusief implanteerbare defibrillatoren)
Engelse titel Implants for surgery - Active implantable medical devices - Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators)

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