This Particular Standard applies to CAPACITOR DISCHARGE X-RAY GENERATORS operating in INTERMITTENT MODE for medical RA DIOGRAPHY, in which the electrical energy for LOADING of the X-RAY TUBE is completely or mainly capacitively stored at, and switched in, the high-voltage circuit.
This Particular Standard is confined to those devices which are MEDICAL ELECTRICAL EQUIPMENT and in which
- the storage capacitor is in the high-voltage circuit and has a specified capacitance not exceeding 2 µF,
- the INITIAL X-RAY TUBE VOLTAGE is between 40 kV and 150 kV,
- an overcurrent protection, if provided, would not require a rating exceeding that which corresponds to an apparent power of 3 kVA,
- LOADING of the X-RAY TUBE is controlled in the high-voltage circuit.
This Particular Standard does not exclude CAPACITOR DISCHARGE X- RAY GENERATORS that are capable of operation in CONTINUOUS MODE for DIRECT RADIOSCOPY or INDIRECT RADIOSCOPY. However, for this mode of operation the device will have to comply with the relevant requirements for diagnostic HIGH-VOLTAGE GENERATORS and diagnostic X-RAY EQUIPMENT.
This Particular Standard applies to CAPACITOR DISCHARGE X-RAY GENERATORS 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, 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.
In this Particular Standard, shall indicates a mandatory requirement; should indicates a recommendation, or that which is advised but not mandatory.
Canadian Deviations and Editorial Changes are included in this Standard.