NF EN 60601-1-9
NF EN 60601-1-9

NF EN 60601-1-9

July 2008
Standard Current

Medical electrical equipment - Part 1-9 : general requirements for basic safety and essential performance - Collateral Standard : requirements for environmentally conscious design

Le présent document s'applique à la réduction des IMPACTS ENVIRONNEMENTAUX négatifs des APPAREILS ELECTROMEDICAUX, désignés ci-après sous le terme APPAREILS EM. Ce document entre dans le champ d'application de la Directive n° 93/42/CEE du 14/06/1993 relative aux dispositifs médicaux.

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Main informations

Collections

National standards and national normative documents

Thematics

QSE, Sécurité

Publication date

July 2008

Number of pages

35 p.

Reference

NF EN 60601-1-9

ICS Codes

13.020.30   Environmental impact assessment
11.040.01   Medical equipment in general

Classification index

C74-019

Print number

1

International kinship

IEC 60601-1-9:2007

European kinship

EN 60601-1-9:2008
Sumary
Medical electrical equipment - Part 1-9 : general requirements for basic safety and essential performance - Collateral Standard : requirements for environmentally conscious design

Le présent document s'applique à la réduction des IMPACTS ENVIRONNEMENTAUX négatifs des APPAREILS ELECTROMEDICAUX, désignés ci-après sous le terme APPAREILS EM. Ce document entre dans le champ d'application de la Directive n° 93/42/CEE du 14/06/1993 relative aux dispositifs médicaux.
Table of contents
  • AVANT-PROPOS
    2
  • INTRODUCTION
    5
  • 1 Domaine d'application, objet et normes connexes
    6
  • 1.1 Domaine d'application
    6
  • 1.2 Objet
    6
  • 1.3 Normes connexes
    6
  • 2 Références normatives
    7
  • 3 Termes et définitions
    7
  • 4 Protection de l'ENVIRONNEMENT
    9
  • 4.1 Identification des ASPECTS ENVIRONNEMENTAUX
    9
  • 4.2 Détermination des ASPECTS ENVIRONNEMENTAUX significatifs
    9
  • 4.3 Information en provenance de la CHAINE D'APPROVISIONNEMENT
    10
  • 4.4 Réduction des IMPACTS ENVIRONNEMENTAUX négatifs
    10
  • 4.5 Informations environnementales
    10
  • Annexe A (informative) Guide général et justifications
    12
  • Annexe B (informative) Guide pour le marquage et exigences d'étiquetage pour les APPAREILS EM
    27
  • Annexe ZA (normative) Références normatives à d'autres publications internationales avec les publications européennes correspondantes
    28
  • Annexe ZZ (informative) Couverture des Exigences Essentielles des Directives CE
    29
  • Bibliographie
    30
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