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NEN-EN 45502-2-3:2006 Ontw. en

Actieve implanteerbare medische hulpmiddelen - Deel 2-3: Bijzondere eisen voor cochlea-implantaatsystemen

Status: Ingetrokken
Publicatiedatum: 01-06-2006 Bekijk een preview
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  • Omschrijving

    • This Part 2-3 of EN 45502, specifies requirements that are applicable to those ACTIVE IMPLANTABLE MEDICAL DEVICES intended to treat hearing impairment via electrical stimulation of the auditory pathways. Devices, which treat hearing impairment via means other than electrical stimulation are not covered by this European Standard. 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.

  • Details
    • ICS - code(s) 13.320: Alarm- en waarschuwingssystemen
    • Nederlandse titel Actieve implanteerbare medische hulpmiddelen - Deel 2-3: Bijzondere eisen voor cochlea-implantaatsystemen
    • Engelse titel Active implantable devices implants - Part 2-3: Particular requirements for cochlear implant systems
    • Engelse samenvatting This Part 2-3 of EN 45502, specifies requirements that are applicable to those ACTIVE IMPLANTABLE MEDICAL DEVICES intended to treat hearing impairment via electrical stimulation of the auditory pathways. Devices, which treat hearing impairment via means other than electrical stimulation are not covered by this European Standard. 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.
    • Vervangen door: , NEN-EN 45502-2-3:2010 en
    • Intrekkingsdatum 03-03-2010
  • Auteurs
    • Commissie: Medische elektrische toestellen / S. Lalout
  • Regels & Verwijzingen
    • Richtlijnen
      • 90/385/EEG : Actieve implanteerbare medische hulpmiddelen (pacemaker richtlijn)

 
 

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