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About This Item

 

Full Description

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).

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.]

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Preface CSA

Ce document constitue la deuxieme edition de la CAN/CSA-C22.2 n? 60601-2-40, Appareils electromedicaux - Partie 2-40 : Exigences particulieres pour la securite de base et les performances essentielles des electromyographes et des appareils a potentiel evoque. Il s'agit de l'adoption, avec exigences propres au Canada, de la norme IEC (Commission Electrotechnique Internationale) 60601-2-40 (deuxieme edition, 2016-08) qui porte le meme titre. Il remplace l'edition anterieure, publiee en 2001 qui portait la designation CAN/CSA-C22.2 n? 60601-2-40 (norme IEC 60601-2-40:1998 adoptee). Il fait partie d'une serie de normes publiees par le Groupe CSA qui constituent le Code canadien de l'electricite, Deuxieme partie.

Par souci de brievete, tout au long de ce document, il sera appele .

Cette norme est concue pour etre utilisee de concert avec la CAN/CSA-C22.2 n? 60601-1:14, Appareils electromedicaux - Partie 1 : Exigences generales pour la securite de base et les performances essentielles (norme IEC 60601-1:2005 adoptee, avec exigences propres au Canada, y compris l'amendement 1:2012).

Domaine d'application et objet

L'Article 1 de la norme generale1 s'applique, a l'exception de ce qui suit:

201.1.1 Domaine d'application

Remplacement:

La presente Norme particuliere s'applique a la SECURITE DE BASE et aux PERFORMANCES ESSENTIELLES des ELECTROMYOGRAPHES et des APPAREILS A POTENTIEL EVOQUE, designes ciapres par APPAREILS EM.

NOTE Les appareils de type (retroaction musculaire) pour lesquels le controle de la contraction musculaire est base sur l'electromyographie relevent du domaine d'application de la presente Norme particuliere.

Si un article ou un paragraphe est specifiquement destine a etre 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 a la fois aux APPAREILS EM et aux SYSTEMES EM, selon le cas.

Les APPAREILS EM suivants sont exclus de la liste:

Les APPAREILS EM destines a etre utilises avec les neurostimulateurs electriques transcutanes et les stimulateurs de muscles electriques (APPAREILS EM couverts par l'IEC 60601-2-10).

201.1.2 Objet

Remplacement:

L'objet de la presente Norme particuliere est d'etablir des exigences particulieres pour la SECURITE DE BASE et les PERFORMANCES ESSENTIELLES des ELECTROMYOGRAPHES et des APPAREILS A POTENTIEL EVOQUE [definis en 201.3.201 et 201.3.202.]

 

Document History

  1. CAN/CSA C22.2 NO. 60601-2-40:17

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    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)

    • Most Recent
  2. 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)

    • Historical Version