Norm

NEN-EN 50077:1994 en

Vlakke connector voor implanteerbare hartritmeregelaars

49,30

Over deze norm

Status Definitief
Aantal pagina's 10
Commissie Chirurgische implantaten
Gepubliceerd op 01-09-1994
Taal Engels
This standard specifies a connector assembly to be used to connect implantable pacemaker leads to implantable pulse generators. Essential dimensions and performance requirements are specified, together with appropriate test methods. However, this standard does not address all aspects of the functional compatibility and reliability of different leads and pulse generators assembled into a pacemaker system: in particular, this standard does not specify certain essential features, such as the means of fastening the connector assembly, or the materials of construction. This standard supplements EN 50061 only for those pacemaker components which are claimed by their labelling to be fitted with an IS-1 connector assembly part. It does not replace any requirement in EN 50061 regarding leads.

Details

ICS-code 11.040.40
Nederlandse titel Vlakke connector voor implanteerbare hartritmeregelaars
Engelse titel Low-profile connector for implantable cardiac pacemakers
Normatieve verwijzingen
  • 90/385/EEG, Actieve implanteerbare medische hulpmiddelen (pacemaker richtlijn)

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