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      • CSA C22.2 NO. 60601-2-40:17 (R2022)

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      CSA C22.2 NO. 60601-2-40:17 (R2022)

      Medical electrical equipment - Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment (Adopted IEC 60601-2-40:2016, second edition , 2016-08, with Canadian deviations) | Appareils électromédicaux — Partie 2-40 : Exigences particulières pour la sécurité de base et les performances essentielles des électromyographes et des appareils à potentiel évoqué (norme IEC 60601-2-40:2016 adoptée, deuxième édition, 2016-08, avec exigences propres au Canada)
      SKU: 2701520 Published by CSA Group Publication Year 2017 Reaffirmed in 2022

      Product Details

      • Preface/Scope
      • Items Included

      CSA Preface


      This is the second edition of CAN/CSA-C22.2 No. 60601-2-40, Medical electrical equipment — Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment, which is an adoption, with Canadian deviations, of the identically titled IEC (International Electrotechnical Commission) Standard 60601-2-40 (second edition, 2016-08). It supersedes the previous edition, published in 2001 as CAN/CSA-C22.2 No. 60601-2-40 (adopted IEC 60601-2-40:1998). 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. 60601-2-40 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).


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


      This Standard was reviewed for Canadian adoption by the CSA Technical Committee on Consumer and Commercial Products, under the jurisdiction of the CSA Strategic Steering Committee on Requirements for Electrical Safety, and has been formally approved by the Technical Committee. Due to the medical content of this Standard, it was also approved by the CSA Technical Committee on Application of Electricity in Health Care, under the jurisdiction of the CSA Strategic Steering Committee on Health Care Technology & Systems.


      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


      Clause 1 of the general standard1 applies, except as follows:


      201.1.1 Scope


      Replacement:


      This particular standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ELECTROMYOGRAPHS and EVOKED RESPONSE EQUIPMENT, hereafter referred to as ME EQUIPMENT.


      NOTE Myofeedback equipment, where the capturing of muscle contraction is based on electromyography, is within the scope of this particular standard.


      If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.


      The following ME EQUIPMENT is excluded:


      ME EQUIPMENT intended for transcutaneous electrical nerve stimulators and electrical muscle stimulators (ME EQUIPMENT covered by IEC 60601-2-10.)


      201.1.2 Object


      Replacement:


      The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for ELECTROMYOGRAPHS and EVOKED RESPONSE EQUIPMENT [as defined in 201.3.201 and 201.3.202.]


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


      Préface CSA


      Ce document constitue la deuxième édition de la CAN/CSA-C22.2 nº 60601-2-40, Appareils électromédicaux — Partie 2-40 : Exigences particulières pour la sécurité de base et les performances essentielles des électromyographes et des appareils à potentiel évoqué. Il s’agit de l’adoption, avec exigences propres au Canada, de la norme IEC (Commission Électrotechnique Internationale) 60601-2-40 (deuxième édition, 2016-08) qui porte le même titre. Il remplace l’édition antérieure, publiée en 2001 qui portait la désignation CAN/CSA-C22.2 nº 60601-2-40 (norme IEC 60601-2-40:1998 adoptée). Il fait partie d’une série de normes publiées par le 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 60601-2-40».


      Cette norme est conçue pour être utilisée de concert avec la 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).


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


      Cette norme a été révisée en vue de son adoption au Canada par le Comité technique CSA sur les produits grand public et commerciaux, sous l’autorité du Comité directeur stratégique CSA sur les exigences en matière de sécurité électricité, et a été officiellement approuvée par le Comité technique. En raison de son contenu médical, la norme a également été approuvée par le Comité technique CSA sur les installations électriques dans les établissements de santé, sous l’autorité du Comité directeur stratégique CSA sur la technologie et les systèmes de soins de santé.


      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 et objet


      L’Article 1 de la norme générale1 s’applique, à l'exception de ce qui suit:


      201.1.1 Domaine d'application


      Remplacement:


      La présente Norme particulière s’applique à la SECURITE DE BASE et aux PERFORMANCES ESSENTIELLES des ELECTROMYOGRAPHES et des APPAREILS A POTENTIEL EVOQUE, désignés ciaprès par APPAREILS EM.


      NOTE Les appareils de type «Myofeedback» (rétroaction musculaire) pour lesquels le contrôle de la contraction musculaire est basé sur l'électromyographie relèvent du domaine d’application de la présente Norme particulière.


      Si un article ou un paragraphe est spécifiquement destiné à être applicable uniquement aux APPAREILS EM ou uniquement aux SYSTEMES EM, le titre et le contenu de cet article ou de ce paragraphe l’indiquent. Si ce n’est pas le cas, l'article ou le paragraphe s’applique à la fois aux APPAREILS EM et aux SYSTEMES EM, selon le cas.


      Les APPAREILS EM suivants sont exclus de la liste:


      Les APPAREILS EM destinés à être utilisés avec les neurostimulateurs électriques transcutanés et les stimulateurs de muscles électriques (APPAREILS EM couverts par l’IEC 60601-2-10).


      201.1.2 Objet


      Remplacement:


      L’objet de la présente Norme particulière est d’établir des exigences particulières pour la SECURITE DE BASE et les PERFORMANCES ESSENTIELLES des ELECTROMYOGRAPHES et des APPAREILS A POTENTIEL EVOQUE [définis en 201.3.201 et 201.3.202.]


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      CSA C22.2 NO. 60601-2-40:17 (R2022)

      Medical electrical equipment - Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment (Adopted IEC 60601-2-40:2016, second edition , 2016-08, with Canadian deviations) | Appareils électromédicaux — Partie 2-40 : Exigences particulières pour la sécurité de base et les performances essentielles des électromyographes et des appareils à potentiel évoqué (norme IEC 60601-2-40:2016 adoptée, deuxième édition, 2016-08, avec exigences propres au Canada)

      Active
      Bilingual

      CAN/CSA-C22.2 NO. 60601-2-40-01 (R2014)

      Medical Electrical Equipment - Part 2-40: Particular Requirements for the Safety of Electromyographs and Evoked Response Equipment (Adopted CEI/IEC 60601-2-40:1998, first edition, 1998-02) | Appareils électromédicaux - Partie 2-40: Règles particulières de sécurité pour les électromyographes et les appareils à potentiel évoqué (norme CEI/IEC 60601-2-40:1998 adoptée, première édition, 1998-02)

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