Medical electrical equipment - Part 2: Particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis
This National Standard of Canada is equivalent to International Standard IEC 601-2-28:1993. 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.