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      • Home
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      • CSA C22.2 NO. 60601-2-44:10 (R2019)

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      CSA C22.2 NO. 60601-2-44:10 (R2019)

      Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography (Adopted IEC 60601-2-44:2009, third edition, 2009-02) | Appareils électromédicaux - Partie 2-44: Exigences particulières pour la sécurité de base et les performances essentielles des équipements à rayonnement X de tomodensitométrie (norme IEC 60601-2-44:2009 adoptée, troisième édition, 2009-02)
      SKU: 2420265 Published by CSA Group Publication Year 2010 Reaffirmed in 2019 119 pages

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      CSA Preface


      This is the second edition of CAN/CSA-C22.2 No. 60601-2-44, Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography, which is an adoption without modification of the identically titled IEC (International Electro technical Commission) Standard 60601-2-44 (third edition, 2009-02). It supersedes the previous edition, published in 2003 as CAN/CSA-C22.2 No. 60601-2-44, Medical electrical equipment - Part 2-44: Particular requirements for the safety of X-ray equipment for computed tomography (adopted IEC 60601-2-44:2001). It is one in a series of Standards issued by CSA under Part II of the Canadian Electrical Code.


      This Standard is intended to be used in conjunction with CAN/CSA-C22.2 No. 60601-1:08, Medical electrical equipment — Part 1: General requirements for basic safety and essential performance (adopted IEC 60601-1:2005, 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


      Replacement:


      This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of CT SCANNERS, hereafter also referred to as ME EQUIPMENT.


      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.


      NOTE 1 See also 4.2 of the general standard.


      The scope of this document is limited to CT SCANNERS intended to be used for both head and body characterised by an ENCLOSURE of the X-ray source (s) and imaging detector(s) in a common protective cover in the shape of a toroid. It includes safety requirements for the XRAY GENERATORS used in CT SCANNERS, including those where HIGH-VOLTAGE GENERATORS are integrated with an X-RAY TUBE ASSEMBLY.


      NOTE 2 Requirements for X-RAY GENERATORS and for ASSOCIATED EQUIPMENT, which were previously specified in IEC 60601-2-7 and IEC 60601-2-32, have been included in either IEC 60601-1:2005 (Ed3) or this edition of IEC 60601-2-44. Therefore IEC 60601-2-7 and IEC 60601-2-32 are not part of the 3rd edition scheme for COMPUTED TOMOGRAPHY.


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


      Préface CSA


      Ce document constitue la deuxième édition de la CAN/CSA-C22.2 nº 60601-2-44, Appareils électromédicaux - Partie 2-44 : Exigences particulières pour la sécurité de base et les performances essentielles les équipements à rayonnement X de tomodensitométrie. Il s'agit de l'adoption, sans modifications, de la norme CEI (Commission Électrotechnique Internationale) 60601-2-44 (troisième édition, 2009-02), qui porte le même titre. Cette norme remplace l'édition précédente publiée en 2003 et intitulée CAN/CSA-C22.2 nº 60601-2-44, Appareils électromédicaux - Partie 2-44 : Règles particulières de sécurité pour les équipements à rayonnement X de tomodensitométrie (norme CEI 601-2-44:2001 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 est conçue pour être utilisée de concert avec la norme CAN/CSA-C22.2 nº60601-1:08, 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).


      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


      Remplacement:


      La présente Norme internationale s'applique à la SÉCURITÉ DE BASE et aux PERFORMANCES ESSENTIELLES des TOMODENSITOMETRES, également désignés ci-après sous le terme APPAREILS EM.


      Si un article ou un paragraphe est spécifiquement destiné à être applicable uniquement aux APPAREILS EM ou uniquement aux SYSTÈMES EM, le titre et le contenu de cet article ou de ce 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 SYSTÈMES EM, selon le cas.


      NOTE 1 Voir aussi 4.2 de la norme générale.


      Le domaine d'application du présent document est limité aux tomodensitomètres destinés à être utilisés pour les examens de la tête et du corps caractérisés par une ENVELOPPE de la (des) source(s) de rayonnement X et du (des) détecteur(s) d'imagerie dans un couvercle de protection commun de forme toroïdale. Cette norme comprend les exigences de sécurité des GENERATEURS RADIOLOGIQUES utilisés dans les TOMODENSITOMETRES, y compris celles pour les GENERATEURS HAUTE TENSION lorsqu'ils sont intégrés avec une GAINE ÉQUIPÉE.


      NOTE 2 Les exigences applicables aux GROUGES RADIOGÈNES et aux APPAREILS ASSOCIÉS, qui étaient auparavant spécifiées dans la CEI 60601-2-7 et dans la CEI 60601-2-32, ont été incorporées soit dans la CEI 60601-1:2005 (Ed3) soit dans la présente édition de la CEI 60601-2-44. Ainsi les CEI 60601-2-7 et 60601-2-32 ne font pas partie du groupe de publications liées à la 3ème édition, concernant la TOMODENSITOMÉTRIE.

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      CAN/CSA-C22.2 NO. 60601-2-44-03(R07)

      Medical Electrical Equipment - Part 2-44: Particular Requirements for the Safety of X-Ray Equipment for Computed Tomography (Adopted IEC 60601-2-44:2001, second edition, 2001-06)

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      CSA C22.2 NO. 60601-2-44B:10 (R2019)

      Amendment 2:2018 to CSA C22.2 NO. 60601-2-44:10, Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography (Adopted amendment 2:2016 to IEC 60601-2-44:2009) | Modification 2:2018 de CSA C22.2 NO. 60601-2-44:10, Appareils électromédicaux - Partie 2-44: Exigences particulières pour la sécurité de base et les performances essentielles des équipements à rayonnement X de tomodensitométrie (Amendement 2:2016 adoptée de la norme CEI 60601-2-44:2009)

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      CSA C22.2 NO. 60601-2-44A:10 (R2019)

      Amendment 1:2014 to CSA C22.2 NO. 60601-2-44:10, Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography (Adopted amendment 1:2012 to IEC 60601-2-44:2009) | Modification 1:2014 de CSA C22.2 NO. 60601-2-44:10, Appareils électromédicaux - Partie 2-44: Exigences particulières pour la sécurité de base et les performances essentielles des équipements à rayonnement X de tomodensitométrie (Amendement 1:2012 adoptée de la norme CEI 60601-2-44:2009)

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