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    • CSA IEC 62366-1:15 (R2020)

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    CSA IEC 62366-1:15 (R2020)

    Medical devices — Part 1: Application of usability engineering to medical devices (Adopted IEC 62366-1:2015, first edition, 2015-02) | Dispositifs médicaux — Partie 1 : Application de l’ingénierie de l’aptitude à l’utilisation aux dispositifs médicaux (norme IEC 62366-1:2015 adoptée, première édition, 2015-02)
    SKU: 2424276 Published by CSA Group Publication Year 2015 Reaffirmed in 2020 140 pages

    Product Details

    • Preface/Scope
    • Updates

    CSA Preface


    This is the first edition of CAN/CSA-IEC 62366-1, Medical devices — Part 1: Application of usability engineering to medical devices, which is an adoption without modification of the identically titled IEC (International Electrotechnical Commission) Standard 62366-1 (first edition, 2015-02). It replaces CAN/CSA-IEC 62366:14 (adopted IEC 62366:2007).


    This first edition of IEC 62366-1, together with the first edition of IEC 62366-2, cancels and replaces the first edition of IEC 62366 published in 2007 and its Amendment 1 (2014). Part 1 has been updated to include contemporary concepts of usability engineering, while also streamlining the process. It strengthens links to ISO 14971:2007 and the related methods of risk management as applied to safety related aspects of medical device user interfaces. Part 2 contains tutorial information to assist manufactures in complying with Part 1, as well as offering more detailed descriptions of usability engineering methods that can be applied more generally to medical devices that go beyond safety related aspects of medical device user interfaces.


    This Standard has been developed in compliance with Standards Council of Canada requirements for National Standards of Canada. It has been published as a National Standard of Canada by CSA Group.


    Scope


    This part of IEC 62366 specifies a PROCESS for a MANUFACTURER to analyse, specify, develop and evaluate the USABILITY of a MEDICAL DEVICE as it relates to SAFETY. This USABILITY ENGINEERING (HUMAN FACTORS ENGINEERING) PROCESS permits the MANUFACTURER to assess and mitigate RISKS 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 1 SAFETY is freedom from unacceptable RISK. Unacceptable RISK can arise from USE ERROR, which can lead to exposure to direct physical HAZARDS or loss or degradation of clinical functionality.


    NOTE 2 Guidance on the application of USABILITY ENGINEERING to MEDICAL DEVICES is available in IEC 62366-22, which addresses not only SAFETY but also aspects of USABILITY not related to SAFETY.


    If the USABILITY ENGINEERING PROCESS detailed in this International Standard has been complied with, then the USABILITY of a MEDICAL DEVICE as it relates to SAFETY is presumed to be acceptable, unless there is OBJECTIVE EVIDENCE to the contrary.


    NOTE 3 Such OBJECTIVE EVIDENCE can subsequently originate from POST-PRODUCTION surveillance.


    --------------------------------------------------------------------------------------------------------------------------------


    Préface CSA


    Ce document constitue la première édition de la CAN/CSA-IEC 62366-1, Dispositifs médicaux — Partie 1 : Application de l’ingénierie de l’aptitude à l’utilisation aux dispositifs médicaux. Il s’agit de l’adoption, sans modification, de la norme IEC (Commission Électrotechnique Internationale) 62366-1 (première édition, 2015-02) qui porte le même titre. Cette norme remplace CAN/CSA-IEC 62366:14 (norme IEC 62366:2007 adoptée).


    La première édition de l’IEC 62366-1, ainsi que la première édition de l’IEC 62366-2, annule et remplace la première édition de l’IEC 62366 parue en 2007 et son Amendement 1 (2014). La Partie 1 a été mise à jour afin d’inclure des concepts contemporains d’ingénierie de l’aptitude à l’utilisation, tout en rationalisant le processus. Elle renforce aussi les liens avec l’ISO 14971:2007 et les méthodes connexes de gestion des risques appliquées aux aspects relatifs à la sécurité des interfaces utilisateur des dispositifs médicaux. La Partie 2 contient des informations didactiques pour aider les fabricants à se conformer à la Partie 1 et fournit des descriptions plus détaillées des méthodes d’ingénierie de l’aptitude à l’utilisation qui peuvent être appliquées d’une façon plus générale aux dispositifs médicaux et qui vont au-delà des aspects relatifs à la sécurité des interfaces utilisateur des dispositifs médicaux.


    Cette norme a été élaborée conformément aux exigences du Conseil canadien des normes concernant les Normes nationales du Canada. Cette norme a été publiée en tant que Norme nationale du Canada par Groupe CSA.


    Domaine d'application


    La présente partie de l'IEC 62366 spécifie un PROCESSUS permettant à un FABRICANT d’analyser, de spécifier, de développer et d'évaluer l'APTITUDE A L’UTILISATION d'un DISPOSITIF MEDICAL, concernant la SECURITE. Ce PROCESSUS D'INGENIERIE DE L’APTITUDE A L'UTILISATION (INGENIERIE DES FACTEURS HUMAINS) permet au FABRICANT d'évaluer et de réduire les RISQUES associés à une UTILISATION CORRECTE et à des ERREURS D’UTILISATION, c’est-à-dire une UTILISATION NORMALE. Il peut être utilisé pour identifier les RISQUES associés à une UTILISATION ANORMALE mais ne les évalue pas et ne les réduit pas.


    NOTE 1 La SECURITE est définie comme l'absence de RISQUE inacceptable. Le RISQUE inacceptable peut provenir d'une ERREUR D'UTILISATION, ce qui peut mener à une exposition à des PHENOMENES DANGEREUX physiques directs ou à une perte ou une dégradation de la fonctionnalité clinique.


    NOTE 2 Des lignes directrices relatives à l'application de l'INGENIERIE DE L’APTITUDE A L'UTILISATION aux DISPOSITIFS MEDICAUX sont disponibles dans l'IEC 62366-22, qui traite non seulement de la SECURITE mais aussi des aspects de l’APTITUDE A L'UTILISATION non relatifs à la SECURITE.


    Si le PROCESSUS D'INGENIERIE DE L’APTITUDE A L'UTILISATION détaillé dans la présente norme internationale a été satisfait, l'APTITUDE A L'UTILISATION d'un DISPOSITIF MEDICAL concernant la SECURITE est alors présumée acceptable, sauf s'il existe une PREUVE TANGIBLE du contraire.


    NOTE 3 Une PREUVE TANGIBLE de ce type peut ensuite provenir de la surveillance POSTPRODUCTION.


    An update to this product is available.


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