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      • CAN/CSA-C22.2 NO. 60601-2-54:11 (R2021)

      Codes & Standards - Purchase

      CAN/CSA-C22.2 NO. 60601-2-54:11 (R2021)

      Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy (Adopted IEC 60601-2-54:2009, first edition, 2009-06) | Appareils électromédicaux - Partie 2-54 : Exigences particulières pour la sécurité de base et les performances essentielles des appareils à rayonnement X utilisés pour la radiographie et la radioscopie (norme IEC 60601-2-54:2009 adoptée, première édition, 2009-06)
      SKU: 2421288 Published by CSA Group Publication Year 2011 Reaffirmed in 2021 166 pages

      Product Details

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      CSA Preface


      This is the first edition of CAN/CSA-C22.2 No. 60601-2-54, Medical electrical equipment — Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy, which is an adoption without modification of the identically titled IEC (International Electrotechnical Commission) Standard 60601-2-54 (first edition, 2009-06). It replaces CAN/CSA-C22.2 No. 60601-2-7-01 (adopted CEI/IEC 60601-2-7:1998) and CAN/CSA-C22.2 No. 601.2.32-98 (adopted CEI/IEC 601-2-32:1994). 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 ME EQUIPMENT and ME SYSTEMS intended to be used for projection RADIOGRAPHY and RADIOSCOPY. IEC 60601-2-43 applies to ME EQUIPMENT and ME SYSTEMS intended to be used for interventional applications and refers to applicable requirements in this particular standard.


      ME EQUIPMENT and ME SYSTEMS intended to be used for bone or tissue absorption densitometry, computed tomography, mammography or dental applications are excluded from the scope of this International Standard. The scope of this International Standard also excludes radiotherapy simulators.


      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 Taking into account economic and social factors, the scope of this particular standard includes ME EQUIPMENT intended to be used for DIRECT RADIOSCOPY. In some countries examinations performed with DIRECT RADIOSCOPY are prohibited.


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


      Préface CSA


      Ce document constitue la première édition de la CAN/CSA-C22.2 nº 60601-2-54, Appareils électromédicaux — Partie 2-54 : Exigences particulières pour la sécurité de base et les performances essentielles des appareils à rayonnement X utilisés pour la radiographie et la radioscopie. Il s’agit de l’adoption, sans modifications, de la norme CEI (Commission Électrotechnique Internationale) 60601-2-54 (première édition, 2009-06), qui porte le même titre. Cette norme remplace la CAN/CSA-C22.2 nº 60601-2-7-01 (norme CEI/IEC 60601-2-7:1998 adoptée) et la CAN/CSA-C22.2 nº 601.2.32-98 (norme CEI/IEC 601-2-32:1994 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 nº 60601-1:08, Appareils électromédicaux — Partie 1 : Exigences générales pour la sécurité de base et les performances essentielles (norme CEI 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 SECURITE DE BASE et aux PERFORMANCES ESSENTIELLES des APPAREILS EM et des SYSTEMES EM destinés à la RADIOGRAPHIE de projection et à la RADIOSCOPIE. La CEI 60601-2-43 est applicable aux APPAREILS EM et aux SYSTEMES EM destinés à être utilisés lors de procédures d'interventions et se réfère aux exigencies applicables de la présente norme particulière.


      Les APPAREILS EM et SYSTEMES EM destinés à l'ostéodensitométrie par absorption, à la tomodensitométrie, à la mammographie ou aux applications dentaires sont exclus du domaine d'application de la présente Norme internationale. Le domaine d'application de la présente Norme internationale exclut également les simulateurs de radiothérapie.


      Si un article ou un paragraphe est spécifiquement destiné à être applicable uniquement aux APPAREILS EM ou uniquement aux SYSTEMES EM, son titre et son contenu l'indiquent. Si cela 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.


      NOTE Le domaine d'application de cette norme particulière, qui prend en compte des facteurs économiques et sociaux, inclut les APPAREILS EM destinés à la RADIOGRAPHIE DIRECTE. Dans certains pays, les examens réalisés à l'aide de la RADIOGRAPHIE DIRECTE sont interdits.

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      CAN/CSA-C22.2 NO. 60601-2-7-01 (R2009)

      CAN/CSA-C22.2 NO. 60601-2-7-01 (R2009) - Medical Electrical Equipment - Part 2-7: Particular Requirements for the Safety of High-Voltage Generators of Diagnostic X-Ray Generators (Adopted IEC 60601-2-7:1998, second edition, 1998-02)

      Withdrawn

      CAN/CSA-C22.2 NO. 601.2.32-98 (R2011)

      CAN/CSA-C22.2 NO. 601.2.32-98 (R2011) - Medical Electrical Equipment - Part 2: Particular Requirements for the Safety of Associated Equipment of X-Ray Equipment (Adopted IEC 601-2-32:1994) | Appareils électromédicaux - Partie 2: Règles particulières de sécurité pour les équipements associés aux équipements à rayonnement X (norme CEI 601-2-32:1994 adoptée)

      Withdrawn

      CAN/CSA-C22.2 NO. 601.2.7-92 (R2001)

      Appareils électromédicaux - Deuxième partie: Règles particulières de sécurité pour générateurs radiologiques de groupes radiogènes de diagnostic (norme CEI 601-2-7:1987 adoptée)

      Withdrawn
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      CAN/CSA-C22.2 NO. 60601-2-54B:11 (R2021)

      Amendment 2:2020 to CAN/CSA-C22.2 NO. 60601-2-54:11 Medical electrical equipment — Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy (Adopted amendment 2:2018 to IEC 60601-2-54:2009 | Modification 2:2020 de CAN/CSA-C22.2 NO. 60601-2-54:11 Appareils électromédicaux — Partie 2-54 : Exigences particulières pour la sécurité de base et les performances essentielles des appareils à rayonnement X utilisés pour la radiographie et la radioscopie (Amendement 2:2018 adoptée de la norme IEC 60601-2-54:2009)

      Active
      Bilingual

      CAN/CSA-C22.2 NO. 60601-2-54A:11 (R2021)

      Amendment 1:2017 to CAN/CSA-C22.2 NO. 60601-2-54:11, Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy (Adopted amendment 1:2015 to IEC 60601-2-54:2009 | Modification 1:2017 de CAN/CSA-C22.2 NO. 60601-2-54:11, Appareils électromédicaux - Partie 2-54 : Exigences particulières pour la sécurité de base et les performances essentielles des appareils à rayonnement X utilisés pour la radiographie et la radioscopie (Amendement 1:2015 adoptée de la norme IEC 60601-2-54:2009)

      Active
      Bilingual

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