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    • Household & Commercial (Appliances, HVAC, Lighting, Others) - Canadian Electrica
    • CAN/CSA-C22.2 NO. 60601-1-6:11 (R2021)

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    CAN/CSA-C22.2 NO. 60601-1-6:11 (R2021)

    Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability (Adopted IEC 60601-1-6:2010, third edition, 2010-01) | Appareils électromédicaux - Partie 1-6: Exigences générales pour la sécurité de base et les performances essentielles - Norme collatérale: Aptitude à l'utilisation (norme IEC 60601-1-6:2010 adoptée, troisième édition, 2010-01)
    SKU: 2421437 Published by CSA Group Publication Year 2011 Reaffirmed in 2021 73 pages

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    CSA Preface


    This is the third edition of CAN/CSA-C22.2 No. 60601-1-6, Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability, which is an adoption without modification of the identically titled IEC (International Electrotechnical Commission) Standard 60601-1-6 (third edition, 2010-01). It supersedes the previous edition, published in 2008 as CAN/CSA-C22.2 No. 60601-1-6 (adopted IEC 60601-1-6:2006). It is one in a series of Standards issued by CSA under Part II of the Canadian Electrical Code.


    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 International Standard specifies a PROCESS for a MANUFACTURER to analyse, specify, design, VERIFY and VALIDATE USABILITY, as it relates to BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT, hereafter referred to as ME EQUIPMENT.


    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.


    If the USABILITY ENGINEERING PROCESS detailed in this collateral standard has been complied with and the acceptance criteria documented in the USABILITY VALIDATION plan have been met (see 5.9 of IEC 62366:2007), then the RESIDUAL RISKS, as defined in ISO 14971, associated with USABILITY of ME EQUIPMENT are presumed to be acceptable, unless there is OBJECTIVE EVIDENCE to the contrary (see 4.1.2 of IEC 62366:2007).


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


    Préface CSA


    Ce document constitue la troisième édition de la CAN/CSA-C22.2 nº 60601-1-6, Appareils électromédicaux - Partie 1-6 : Exigences générales pour la sécurité de base et les performances essentielles - Norme collatérale : Aptitude à l'utilisation. Il s'agit de l'adoption, sans modifications, de la norme CEI (Commission Électrotechnique Internationale) 60601-1-6 (troisième édition, 2010-01), qui porte le meme titre. Cette norme remplace l'édition précédente publiée en 2008 qui portait la designation CAN/CSA-C22.2 nº 60601-1-6 (norme CEI 60601-1-6:2006 adoptée). Cette norme fait partie d'une série de normes publiées par CSA lesquelles constituent le Code canadien de l'électricité, Deuxième partie.


    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 Norme internationale spécifie un PROCESSUS destiné à un FABRICANT pour analyser, spécifier, concevoir, VÉRIFIER et VALIDER l'APTITUDE À L'UTILISATION, ayant trait à la SÉCURITÉ DE BASE et aux PERFORMANCES ESSENTIELLES des APPAREILS ÉLECTROMÉDICAUX, désignés ci-après sous le terme d'APPAREILS EM.


    Ce PROCESSUS D'INGÉNIERIE DE L'APTITUDE À L'UTILISATION évalue et réduit les RISQUES provoqués par les problèmes D'APTITUDE À L'UTILISATION associés à une UTILISATION CORRECTE et à des ERREURS D'UTILISATION, c'est-à-dire une UTILISATION NORMALE. Il peut être utilisé pour identifier mais n'évalue pas et ne réduit pas les RISQUES associés à une UTILISATION ANORMALE.


    Si le PROCESSUS D'INGÉNIERIE DE L'APTITUDE À L'UTILISATION détaillé dans la présente norme collatérale a été satisfait et si les critères d'acceptation documentés dans le plan de VALIDATION DE L'APTITUDE À L'UTILISATION ont été satisfaits (voir le 5.9 de la CEI 62366:2007), les RISQUES RÉSIDUELS définis dans l'ISO 14971 associés à l'APTITUDE À L'UTILISATION d'un APPAREIL EM sont alors présumés acceptables, sauf s'il existe une PREUVE TANGIBLE du contraire (voir le 4.1.2 de la CEI 62366:2007).

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    CAN/CSA-C22.2 NO. 60601-1-6-08

    CAN/CSA-C22.2 NO. 60601-1-6-08 - Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability (Adopted IEC 60601-1-6:2006, second edition, 2006-12)

    Withdrawn

    CAN/CSA-C22.2 NO. 60601-1-6-05

    Medical Electrical Equipment - Part 1-6: General Requirements for Safety - Collateral Standard: Usability (Adopted CEI/IEC 60601-1-6:2004, first edition, 2004-06) | Appareils électromédicaux - Partie 1-6: Règles générales de sécurité - Norme collatérale: Aptitude à l'utilisation (norme CEI/IEC 60601-1-6:2004 adoptée, première édition, 2004-06)

    Withdrawn
    items 1 - of 2 result(s)
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    CAN/CSA-C22.2 NO. 60601-1-6:11/A2:21 (R2021)

    Amendment 2:2021 to CAN/CSA-C22.2 NO. 60601-1-6:11, Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability (Adopted amendment 1:2020 to IEC 60601-1-6:2010) | Modification 2:2021 de CAN/CSA-C22.2 NO. 60601-1-6:11, Appareils électromédicaux - Partie 1-6: Exigences générales pour la sécurité de base et les performances essentielles - Norme collatérale: Aptitude à l'utilisation (Amendement 1:2020 adoptée de la norme IEC 60601-1-6:2010)

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    CAN/CSA-C22.2 NO. 60601-1-6:11/A1:15 (R2021)

    Amendment 1:2015 to CAN/CSA-C22.2 NO. 60601-1-6:11, Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability (Adopted amendment 1:2013 to IEC 60601-1-6:2010) | Modification 1:2015 de CAN/CSA-C22.2 NO. 60601-1-6:11, Appareils électromédicaux - Partie 1-6: Exigences générales pour la sécurité de base et les performances essentielles - Norme collatérale: Aptitude à l'utilisation (Amendement 1:2013 adoptée de la norme IEC 60601-1-6:2010)

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