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      • CAN/CSA-C22.2 NO. 60601-1-6:11 + A1:15 + A2:21 (R2021) (CONSOLIDATED)

      Codes & Standards - Purchase

      CAN/CSA-C22.2 NO. 60601-1-6:11 + A1:15 + A2:21 (R2021) (CONSOLIDATED)

      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, consolidated with amendment 1:2013 and amendment 2:2020, with Canadian deviations) | 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, consolidée par l’amendement 1:2013 et l’amendement 2:2020, avec exigences propres au Canada)

      SKU: 2429755 Published by CSA Group Publication Year 2022 Reaffirmed in 2021 118 pages

      Product Details

      • Preface/Scope

      CSA Preface


      This is consolidated edition 3.2 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, with Canadian deviations, of the identically titled IEC (International Electrotechnical Commission) Standard 60601-1-6 (edition 3:2010 consolidated with Amendment 1:2013 and Amendment 2:2020). It supersedes the second 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 Group under Part II of the Canadian Electrical Code.


      For brevity, this Standard will be referred to as CAN/CSA-C22.2 No. 60601-1-6 throughout.


      This Standard is intended to be used in conjunction with CAN/CSA-C22.2 No. 60601-1:14, Medical electrical equipment — Part 1: General requirements for basic safety and essential performance (adopted IEC 60601-1:2005, including Amendment 1:2012, with Canadian deviations).


      Where differences exist between this consolidated edition and the published edition and its amendments, those documents will take precedence.


      This Standard is considered suitable for use for conformity assessment within the stated scope of the Standard.


      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 and object


      1.1 * Scope


      This International Standard specifies a PROCESS for a MANUFACTURER to analyse, specify, develop and evaluate the 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, then the USABILITY of ME EQUIPMENT as it relates to BASIC SAFETY and ESSENTIAL PERFORMANCE is presumed to be acceptable, unless there is OBJECTIVE EVIDENCE to the contrary.


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


      1.2 Object


      The object of this collateral standard is to specify general requirements that are in addition to those of the general standard and to serve as the basis for particular standards.


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


      Préface CSA


      Ce document constitue l’édition 3.2 consolidée de 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, avec exigences propres au Canada, de la norme IEC (Commission Électrotechnique Internationale) 60601-1-6 (édition 3:2010 consolidée par l’amendement 1:2013 et l’amendement 2:2020), qui porte le même titre. Cette norme remplace la deuxième édition publiée en 2008 qui portait la désignation CAN/CSA-C22.2 nº 60601-1-6 (norme IEC 60601-1-6:2006 adoptée). Il fait partie d’une série de normes publiées par Groupe CSA qui constituent le Code canadien de l’électricité, Deuxième partie.


      Par souci de brièveté, tout au long de ce document, il sera appelé « CAN/CSA-C22.2 nº 60601-1-6 ».


      Cette norme est conçue pour être utilisée de concert avec CAN/CSA-C22.2 nº 60601-1:14, Appareils électromédicaux — Partie 1 : Exigences générales pour la sécurité de base et les performances essentielles (norme IEC 60601-1:2005 adoptée, avec exigences propres au Canada), y compris l’amendement 1:2012).


      Lorsqu’il y a des différences entre cette édition consolidée et l’édition publiée et ses amendements, ces derniers auront préséance.


      Cette norme est jugée convenable à l’évaluation de la conformité selon le domaine d’application établi dans la norme.


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


      Domaine d'application et objet


      1.1 * Domaine d'application


      La présente Norme internationale spécifie un PROCESSUS destiné à un FABRICANT pour analyser, spécifier, élaborer et évaluer l'APTITUDE A L'UTILISATION, ayant trait à la SECURITE DE BASE et aux PERFORMANCES ESSENTIELLES des APPAREILS ELECTROMEDICAUX, désignés ci-après sous le terme d'APPAREILS EM.


      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-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 D’APTITUDE À L’UTILISATION décrit en détail dans la présente norme collatérale a été respecté, l’APTITUDE À L’UTILISATION des APPAREILS EM, dans la mesure où elle a trait à la SÉCURITÉ DE BASE et aux PERFORMANCES ESSENTIELLES, est présumée acceptable, sauf s'il existe une PREUVE TANGIBLE du contraire.


      NOTE Cette PREUVE TANGIBLE peut provenir ultérieurement du contrôle de la POSTPRODUCTION.


      1.2 Objet

      La présente norme collatérale est destinée à spécifier des exigences générales qui viennent compléter celles de la norme générale et à servir de base pour les normes particulières.

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