Norm

NEN-EN 50061:1991 en

Veiligheid van implanteerbare hartritmeregelaars

  • Deze norm is ingetrokken sinds 24-04-2008

61,30

Over deze norm

Status Ingetrokken
Aantal pagina's 24
Commissie Chirurgische implantaten
Gepubliceerd op 01-08-1991
Taal Engels
This standard specifies safety and other requirements exclusively for all types of wholly implantable cardiac pacemakers. This standard also establishes basic terminology and definitions and includes requirements for the marking of pacemakers and their packaging. In addition, minimum requirements are specified for the ability of pacemakers to withstand environmental stress conditions. Appropiate test methods are given. This standard specifies the requirements for the reliable operation of pacemakers only insofar as they affect safety. It does not cover the antitachyarrythmia and defibrillation functions of pacemakers, nor pacemakers operated by isotopic cells.

Details

ICS-code 11.040.40
Nederlandse titel Veiligheid van implanteerbare hartritmeregelaars
Engelse titel Safety of implantable cardiac pacemakers
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Gewijzigd door
Normatieve verwijzingen
  • 89/336/EEG, Elektromagnetische compatibiliteit

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