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    • CSA C22.2 NO. 80601-2-77:19

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    CSA C22.2 NO. 80601-2-77:19

    Medical electrical equipment — Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment (Adopted IEC 80601-2-77:2019, first edition, 2019-07, with Canadian deviations) | Appareils électromédicaux — Partie 2-77 : Exigences particulières pour la sécurité de base et les performances essentielles des appareils chirurgicaux robotiquement assistés (norme IEC 80601-2-77:2019 adoptée, première édition, 2019-07, avec exigences propres au Canada)

    SKU: 2704692 Published by CSA Group Publication Year 2019

    Product Details

    • Preface/Scope
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    CSA Preface


    This is the first edition of CSA C22.2 No. 80601-2-77, Medical electrical equipment — Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment, which is an adoption, with Canadian deviations, of the identically titled IEC (International Electrotechnical Commission) Standard 80601-2-77 (first edition, 2019-07). 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 CSA C22.2 No. 80601-2-77 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 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 standard3 applies, except as follows:


    201.1.1 Scope


    Replacement:


    This part of IEC 80601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ROBOTICALLY ASSISTED SURGICAL EQUIPMENT (RASE) and ROBOTICALLY ASSISTED SURGICAL SYSTEMS (RASS), hereafter referred to as ME EQUIPMENT and ME SYSTEMS together with their INTERACTION CONDITIONS and INTERFACE CONDITIONS. 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.


    If RASE or RASS, or its ACCESSORIES fall within scope of another particular standard, then the particular standard applies in addition to this standard.


    EXAMPLES IEC 60601-2-2[3] for HF SURGICAL EQUIPMENT; IEC 60601-2-18[4] for ENDOSCOPIC EQUIPMENT; IEC 60601-2-22[5] for laser equipment; IEC 60601-2-37[6] for ultrasound equipment; IEC 60601-2-46[7] for operating tables, etc.


    201.1.2 Object


    Replacement:


    The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for ROBOTICALLY ASSISTED SURGICAL EQUIPMENT and ROBOTICALLY ASSISTED SURGICAL SYSTEMS.


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


    Préface CSA


    Ce document constitue la première édition de CSA C22.2 nº 80601-2-77, Appareils électromédicaux — Partie 2-77 : Exigences particulières pour la sécurité de base et les performances essentielles des appareils chirurgicaux robotiquement assistés. Il s’agit de l’adoption, avec exigences propres au Canada, de la norme IEC (Commission Électrotechnique Internationale) 80601-2-77 (première édition, 2019-07), qui porte le même titre. 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 « CSA C22.2 nº 80601-2-77 ».


    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).


    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 générale 3 s'applique, avec les exceptions suivantes:


    201.1.1 Domaine d’application


    Remplacement:


    La présente partie de l'IEC 80601 s'applique à la SECURITE DE BASE et aux PERFORMANCES ESSENTIELLES des APPAREILS CHIRURGICAUX ROBOTIQUEMENT ASSISTES (RASE) et des SYSTEMES D’ELECTROCHIRURGIE ROBOTIQUEMENT ASSISTES (RASS), appelés APPAREILS EM et SYSTEMES EM dans la suite du texte, ainsi qu'à leurs CONDITIONS D’INTERACTION et leurs CONDITIONS D’INTERFACE. Si un article ou un paragraphe est destiné spécifiquement à s’appliquer uniquement aux APPAREILS EM ou aux SYSTEMES EM, le titre et le contenu dudit article ou dudit paragraphe l’indiquent. Si tel 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.


    Si les RASE ou les RASS, ou leurs ACCESSOIRES relèvent du domaine d’application d’une autre norme particulière, ladite norme particulière s’applique en plus de la présente norme.


    EXEMPLES L’IEC 60601-2-2[3] pour les APPAREILS CHIRURGICAUX HF; l’IEC 60601-2-18[4] pour les APPAREILS D'ENDOSCOPIE; l’IEC 60601-2-22[5] pour les appareils à laser; l’IEC 60601-2-37[6] pour les appareils à ultrasons; l’IEC 60601-2-46[7] pour les tables d’opération, etc.


    201.1.2 Objet


    Remplacement:


    La présente norme particulière a pour objet l'établissement d'exigences particulières concernant la SECURITE DE BASE et les PERFORMANCES ESSENTIELLES des APPAREILS CHIRURGICAUX ROBOTIQUEMENT ASSISTES et des SYSTEMES D'ELECTROCHIRURGIE ROBOTIQUEMENT ASSISTES.

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    CSA C22.2 NO. 80601-2-77:19

    Medical electrical equipment — Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment (Adopted IEC 80601-2-77:2019, first edition, 2019-07, with Canadian deviations) | Appareils électromédicaux — Partie 2-77 : Exigences particulières pour la sécurité de base et les performances essentielles des appareils chirurgicaux robotiquement assistés (norme IEC 80601-2-77:2019 adoptée, première édition, 2019-07, avec exigences propres au Canada)

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