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About This Item

 

Full Description

1.1

Scope

This Standard applies to X-RAY SOURCE ASSEMBLIES and X-RAY TUBE ASSEMBLIES for medical diagnosis, and to components thereof, specified for use in medical X-RAY EQUIPMENT, including equipment for COMPUTED TOMOGRAPHY, that incorporates a specified HIGH-VOLTAGE GENERATOR complying with CSA Standard CAN/CSA-C22.2 No. 601.2.7 or CAN/CSA-C22.2 No. 601.2.15.

This Particular Standard applies to X-RAY SOURCE ASSEMBLIES and X-RAY TUBE ASSEMBLIES for medical diagnosis, and to components thereof, hereinafter referred to as EQUIPMENT, designed to be installed and used in accordance with the rules of the Canadian Electrical Code, Part I.

The requirements of this Particular Standard are in addition to those of CSA Standard CAN/CSA-C22.2 No. 601.1, Medical Electrical Equipment, Part 1: General Requirements for Safety, and its supplement C22.2 No. 601.1S1 (adopted amendment 1 to IEC 601-1), hereinafter referred to as the General Standard. For the purposes of testing and approving EQUIPMENT covered within the scope of this Particular Standard, the EQUIPMENT must meet the combined requirements, as applicable, of both this Particular Standard and the General Standard.

Canadian Deviations and Editorial Changes are included in this Standard. /

1.1

Domaine d'application

Cette Norme s'applique aux ENSEMBLES RADIOGENES A RAYONNEMENT X et aux GAINES EQUIPEES pour diagnostic medical et aux composants de ceux-ci, specifies pour utilisation dans un EQUIPEMENT A RAYONNEMENT X, y compris les equipements pour TOMODENSITOMETRIE, qui comprennent un GENERATEUR RADIOLOGIQUE specifie en conformite avec la norme CAN/CSA-C22.2 no 601.2.7 ou CAN/CSA-C22.2 n o 601.2.15.

Cette Norme Particuliere s'applique aux ENSEMBLES RADIOGENES A RAYONNEMENT X et aux GAINES EQUIPEES pour diagnostic medical et aux composants de ceux-ci ci-apres appeles APPAREILS. Ces APPAREILS doivent etre concus pour etre installes et utilises conformement au Code canadien de l'electricite, Premiere partie.

Les prescriptions enoncees dans cette Norme Particuliere s'ajoutent a celles de la norme CAN/CSA-C22.2 no 601.1, Appareils electromedicaux - Premiere partie: Regles generales de securite, et de son supplement CAN/CSA-C22.2 no 601.1S1 (adoption de l'amendement 1 a la norme CEI 601-1), denommee ci- apres . En ce qui a trait a la mise a l'essai et a l' approbation d'APPAREILS conformement a la presente norme, les APPAREILS doivent, le cas echeant, satisfaire a la fois aux prescriptions de la Norme Particuliere et a celles de la Norme Generale.

Cette Norme contient des prescriptions propres au Canada et des modifications d'ordre redactionnel.