Norm

NEN-ISO 14708-2:2012 en

Chirurgische implantaten - Actieve implanteerbare medische hulpmiddelen - Deel 2: Hartritmeregelaars

161,21

Over deze norm

Status Definitief
Aantal pagina's 68
Commissie Chirurgische implantaten
Gepubliceerd op 01-08-2012
Taal Engels
This part of ISO 14708 specifies requirements that are applicable to those ACTIVE IMPLANTABLE MEDICAL DEVICES intended to treat bradyarrhythmias. The tests that are specified in this part of 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 (see NOTE 1). The electrical characteristics of the implantable pulse generator OR LEAD are determined either by the appropriate method detailed in this particular standard or by any other method demonstrated to have an accuracy equal to, or better than, the method specified. In case of dispute, the method detailed in this particular standard applies. Any features of an ACTIVE IMPLANTABLE MEDICAL DEVICE intended to treat tachyarrhythmias are covered by ISO 14708-6.

Details

ICS-code 11.040.40
Nederlandse titel Chirurgische implantaten - Actieve implanteerbare medische hulpmiddelen - Deel 2: Hartritmeregelaars
Engelse titel Implants for surgery - Active implantable medical devices - Part 2: Cardiac pacemakers

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