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    • CAN/CSA-IEC 62366:14

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    CAN/CSA-IEC 62366:14

    Medical devices - Application of usability engineering to medical devices (Adopted IEC 62366:2007, first edition, 2007-10) | Dispositifs médicaux - Application de l'ingénierie de l'aptitude à l'utilisation aux dispositifs médicaux (norme CEI 62366:2007 adoptée, première édition , 2007-10)
    SKU: 2422976 Published by CSA Group Publication Year 2014 240 pages Withdrawn

    Product Details

    • Preface/Scope
    Preface

    This is the first edition of CAN/CSA-IEC 62366, Medical devices - Application of usability engineering to medical devices, which is an adoption without modification of the identically titled IEC (International Electrotechnical Commission) Standard 62366 (first edition, 2007-10). For brevity, this Standard will be referred to as CAN/CSA-IEC 62366 throughout. 

    Scope

    This International Standard specifies a PROCESS for a MANUFACTURER to analyse, specify, design, VERIFY and VALIDATE USABILITY, as it relates to SAFETY of a MEDICAL DEVICE. This USABILITY ENGINEERING PROCESS assesses and mitigates RISKS caused by USABILITY problems associated with CORRECT USE and USE ERRORS, i.e. NORMAL USE. It can be used to identify but does not assess or mitigate RISKS associated with ABNORMAL USE. 

    NOTE For the purposes of this standard, USABILITY (see 3.17) is limited to characteristics of the USER INTERFACE. 

    If the USABILITY ENGINEERING PROCESS detailed in this International Standard has been complied with and the acceptance criteria documented in the USABILITY VALIDATION plan have been met (see 5.9), then the RESIDUAL RISKS, as defined in ISO 14971, associated with USABILITY of a MEDICAL DEVICE are presumed to be acceptable, unless there is OBJECTIVE EVIDENCE to the contrary (see 4.1.2). 

    This International Standard does not apply to clinical decision-making relating to the use of a MEDICAL DEVICE. 
    ----------------------------------------------------------------------------------

    Préface 

    Ce document constitue la première édition de la CAN/CSA-IEC 62366, Dispositifs médicaux - Application de l'ingénierie de l'aptitude à l'utilisation aux dispositifs médicaux. Il s'agit de l'adoption, sans modification, de la norme CEI (Commission Électrotechnique Internationale) 62366 (première édition, 2007-10) qui porte le même titre. Par souci de brièveté, tout au long de ce document, il sera appelé «CAN/CSA-IEC 62366». 

    Domaine d'application

    La présente Norme internationale spécifie un PROCESSUS permettant à un FABRICANT d'analyser, de spécifier, de concevoir, de VÉRIFIER et de VALIDER L'APTITUDE A L'UTILISATION concernant la SECURITE d'un DISPOSITIF MEDICAL. Ce PROCESSUS D'INGENIERIE DE L'APTITUDE A L'UTILISATION évalue et réduit les RISQUES provoqués par les problèmes D'APTITUDE A L'UTILISATION associés à une UTILISATION CORRECTE et à des ERREURS D'UTILISATION, c'est-àdire une UTILISATION NORMALE. Il peut être utilisé pour identifier mais n'évalue pas et ne réduit pas les RISQUES associés à une UTILISATION ANORMALE. 

    NOTE Pour les besoins de la présente norme, L'APTITUDE À L'UTILISATION (voir 3.17) se limite aux caractéristiques DE L'INTERFACE UTILISATEUR. 

    Si le PROCESSUS D'INGENIERIE DE L'APTITUDE A L'UTILISATION détaillé dans la présente Norme internationale a été satisfait et si les critères d'acceptation documentés dans le plan de VALIDATION DE L'APTITUDE A L'UTILISATION ont été satisfaits (voir 5.9), les RISQUES RESIDUELS définis dans l'ISO 14971 associés à L'APTITUDE A L'UTILISATION d'un DISPOSITIF MÉDICAL sont alors présumés acceptables, sauf s'il existe une PREUVE TANGIBLE du contraire (voir 4.1.2). 

    La présente Norme internationale ne s'applique pas à la prise de décision clinique relative à l'utilisation d'un DISPOSITIF MEDICAL.
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