Norm

NEN-EN 45502-2-2:2008 en

Actieve implanteerbare medische hulpmiddelen - Deel 2-2: Bijzondere eisen voor actieve implanteerbare medische hulpmiddelen bestemd voor de behandeling van tachyarrhytmia (inclusief implanteerbare defibrillators)

Volledig inclusief:

110,00

Over deze norm

Status Definitief
Aantal pagina's 104
Commissie Medische elektrische toestellen
Gepubliceerd op 01-04-2008
Taal Engels
This Part 2-2 of EN 45502 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 EN 45502 are type tests and are to be carried out on samples of a device to show compliance. This part of EN 45502 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 particular standard 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 Particular Standard shall apply. Any aspect of an ACTIVE IMPLANTABLE MEDICAL DEVICE intended to treat bradyarrhythmias is covered by EN 45502-2-1 Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (Pacemakers). NOTE 1 The device that is commonly referred

Details

ICS-code 11.040.40
Nederlandse titel Actieve implanteerbare medische hulpmiddelen - Deel 2-2: Bijzondere eisen voor actieve implanteerbare medische hulpmiddelen bestemd voor de behandeling van tachyarrhytmia (inclusief implanteerbare defibrillators)
Engelse titel Active implantable medical devices - Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes impantable defibrillators)
Vervangt
Gewijzigd door
Normatieve verwijzingen
  • 90/385/EEG, Actieve implanteerbare medische hulpmiddelen (pacemaker richtlijn)

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