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MEDICAL ELECTRICAL EQUIPMENT - PART 1-6: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: USABILITY
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Published date: 12-01-2013
Publisher: Association Francaise de Normalisation
AVANT-PROPOSINTRODUCTION1 Domaine d'application, objet et normes connexes2 Références normatives3 Termes et définitions4 Exigences générales5 Identification, marquage et documentation des APPAREILS EM6 ERREUR D'UTILISATION et APTITUDE A L'UTILISATIONAnnexe A (informative) Guide général et justificationsAnnexe B (informative) Taxinomie des actions de l'OPÉRATEURAnnexe C (informative) Exemples d'ERREURS D'UTILISATION, d'UTILISATIONS ANORMALES et de défauts de conception conduisant potentiellement à des ERREURS D'UTILISATIONAnnexe D (informative) Guide pour le PROCESSUS D'INGÉNIERIE D'APTITUDE A L'UTILISATIONAnnexe E (informative) Exemple de SPECIFICATION DE L'APTITUDE A L'UTILISATIONAnnexe F (informative) Documents de référenceAnnexe ZZ (informative) Couverture des Exigences Essentielles des Directives CEBibliographieIndex des termes définis dans la présente norme collatéraleAnnexe 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.
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