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NEN-EN 45502-2-3:2010 en

Normomslag

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

Status: Definitief
Publicatiedatum: 01-03-2010 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 that are 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:
    • Nederlandse titel Actieve implanteerbare medische hulpmiddelen - Deel 2-3: Bijzondere eisen voor cochlea en gehoor hersenstam implantaatsystemen
    • Engelse titel Active implantable medical devices - Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems
    • Engelse samenvatting This Part 2-3 of EN 45502 specifies requirements that are applicable to those ACTIVE IMPLANTABLE MEDICAL DEVICES that are 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.
    • Vervangt: NEN-EN 45502-2-3:2006 Ontw. en
  • Auteurs
    • Commissie: Medische elektrische toestellen / S. Lalout
  • Regels & Verwijzingen
    • Richtlijnen
      • 90/385/EEG : Actieve implanteerbare medische hulpmiddelen

 
 

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