NF EN 50061
NF EN 50061

NF EN 50061

July 1988
Standard Cancelled

Safety of implantable cardiac pacemakers

Ce document concernant un accessoire des stimulateurs cardiaques implantables spécifie les dimensions et les exigences de performance de celui-ci avec leurs méthodes d'essais. Il doit être lu conjointement à la norme NF EN 50061 (classement C 74-346 - juillet 1988).

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Main informations

Collections

National standards and national normative documents

Publication date

July 1988

Number of pages

36 p.

Reference

NF EN 50061

ICS Codes

11.040.40   Implants for surgery, prosthetics and orthotics
11.040.60   Therapy equipment

Classification index

C74-346

Print number

1

European kinship

EN 50061:1988
Sumary
Safety of implantable cardiac pacemakers

Ce document concernant un accessoire des stimulateurs cardiaques implantables spécifie les dimensions et les exigences de performance de celui-ci avec leurs méthodes d'essais. Il doit être lu conjointement à la norme NF EN 50061 (classement C 74-346 - juillet 1988).
Replaced standards (2)
NF C74-346
NF C74-346
March 1982
Standard Cancelled
Electromedical equipment. Implantable cardiac pacemakers with electro-chemical power source.

NF C74-346/A1
NF C74-346/A1
December 1983
Standard Cancelled
Additif 1 à la norme NF C 74-346 de mars 1982.

Standard replaced by (2)
NF EN 45502-2-1
NF EN 45502-2-1
May 2004
Standard Current
Active implantable medical devices - Part 2-1 : particular requirements for active implantable medical devices intended to treat bradyarrhythmia (Cardiac pacemakers)

Le présent document spécifie les règles applicables aux DISPOSITIFS MEDICAUX IMPLANTABLES ACTIFS destinés au traitement de la bradyarythmie. Ce document entre dans le champ d'application de la Directive Dispositifs médicaux implantables actifs n° 90/385/CEE.

NF EN 45502-2-2
NF EN 45502-2-2
July 2008
Standard Current
Active implantable medical devices - Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators)

Table of contents
  • AVANT-PROPOS
    2
  • Introduction
    4
  • 1 Domaine d'application
    4
  • 2 Références normatives
    4
  • 3 Définitions
    4
  • 4 Prescriptions
    6
  • 4.1 Connecteur de la sonde
    6
  • 4.2 Connecteur du générateur
    9
  • ANNEXE A (normative) Méthode d'essai de l'isolement électrique du connecteur de la sonde
    11
  • ANNEXE B (informative) Justifications
    13
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