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NF EN 60601-1-6 : 2010 AMD 1 2015

Current

Current

The latest, up-to-date edition.

MEDICAL ELECTRICAL EQUIPMENT - PART 1-6: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: USABILITY

Published date

12-01-2013

AVANT-PROPOS
INTRODUCTION
1 Domaine d'application, objet et normes connexes
2 Références normatives
3 Termes et définitions
4 Exigences générales
5 Identification, marquage et documentation des
  APPAREILS EM
6 ERREUR D'UTILISATION et APTITUDE A L'UTILISATION
Annexe A (informative) Guide général et justifications
Annexe B (informative) Taxinomie des actions de
          l'OPÉRATEUR
Annexe C (informative) Exemples d'ERREURS D'UTILISATION,
          d'UTILISATIONS ANORMALES et de défauts de conception
          conduisant potentiellement à des ERREURS
          D'UTILISATION
Annexe D (informative) Guide pour le PROCESSUS
          D'INGÉNIERIE D'APTITUDE A L'UTILISATION
Annexe E (informative) Exemple de SPECIFICATION
          DE L'APTITUDE A L'UTILISATION
Annexe F (informative) Documents de référence
Annexe ZZ (informative) Couverture des Exigences
          Essentielles des Directives CE
Bibliographie
Index des termes définis dans la présente norme collatérale
Annexe ZA (normative) Références normatives à d'autres
          publications internationales avec les publications
          européennes correspondantes

Defines requirements for a PROCESS to analyse, design, verify and validate the USABILITY, as it relates to BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT, hereafter referred to as ME EQUIPMENT.

DevelopmentNote
Indice de classement: C74-016PR. PR NF EN 60601-1-6 January 2005. (01/2005) PR NF EN 60601-1-6 April 2006. (04/2006) PR NF EN 60601-1-6 November 2009. (11/2009)
DocumentType
Standard
PublisherName
Association Francaise de Normalisation
Status
Current

NF EN 60601-1-8 : 2007 AMD 11 2018 MEDICAL ELECTRICAL EQUIPMENT - PART 1-8: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: GENERAL REQUIREMENTS, TESTS AND GUIDANCE FOR ALARM SYSTEMS IN MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS
NF EN ISO 10651-6 : 2009 LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 6: HOME-CARE VENTILATORY SUPPORT DEVICES
NF EN 60601-1 : 2007-01 MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE
NF EN ISO 17510-1 : 2009 SLEEP APNOEA BREATHING THERAPY - PART 1: SLEEP APNOEA BREATHING THERAPY EQUIPMENT
NF EN 60601-1-10 : 2008 AMD 1 2015 MEDICAL ELECTRICAL EQUIPMENT - PART 1-10: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR THE DEVELOPMENT OF PHYSIOLOGIC CLOSED-LOOP CONTROLLERS

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