NF EN 60601-1-6 : 2010 AMD 1 2015
Current
The latest, up-to-date edition.
MEDICAL ELECTRICAL EQUIPMENT - PART 1-6: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: USABILITY
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)
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| DocumentType |
Standard
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| PublisherName |
Association Francaise de Normalisation
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| Status |
Current
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| Standards | Relationship |
| UNE-EN 60601-1-6:2010 | Identical |
| BS EN 60601-1-6 : 2010 | Identical |
| EN 60601-1-6:2010/A1:2015 | Identical |
| IEC 60601-1-6:2010+AMD1:2013 CSV | Identical |
| DIN EN 60601-1-6 : 2016 | Identical |
| I.S. EN 60601-1-6:2010 | Identical |
| 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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