Norm

ISO 14708-2:2005 en

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

  • Deze norm is ingetrokken sinds 22-08-2012

164,52

Over deze norm

Status Ingetrokken
Aantal pagina's 96
Commissie Chirurgische implantaten
Gepubliceerd op 01-10-2005
Taal Engels
This Part 2 specifies requirements that are applicable to those ACTIVE IMPLANTABLE MEDICAL DEVICES intended to treat bradyarrhythmias. 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 2 is also applicable to some non-implantable parts and accessories of the devices (see Note 1). The characteristics of the IMPLANTABLE PULSE GENERATOR or LEAD shall be determined by either the appropriate method detailed in this Part 2 or by any other method demonstrated to have an accuracy equal to, or better than, the method specified. In the case of dispute, the method detailed in this Part 2 shall apply. Any features of an ACTIVE IMPLANTABLE MEDICAL DEVICE intended to treat tachyarrhythmias are covered by another ISO document under development.

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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