1. Scope
1.1
This Standard applies to diagnostic imaging and radiation therapy equipment designed to be (a) installed and used in accordance with the Canadian Electrical Code, Part I while connected to supply circuits with nominal system voltages of 750 V and less; and (b) battery powered, insofar as the requirements are applicable.
1.2
This Standard applies to:
a) diagnostic imaging equipment;
b) radiation therapy equipment;
c) lasers for medical applications;
d) ancillary components which are an integral part of the systems of (a), (b), and (c); and (e) stand-alone accessories used in conjunction with the equipment of (a), (b), and (c).
Notes: (1) Diagnostic imaging equipment includes gamma cameras, diagnostic ultrasound units, computerized tomography units, magnetic resonance imaging systems, fluoroscopic devices, radiographic units, therapy simulators, digital subtraction angiography units, and lithotripters. (2) Radiation therapy equipment includes linear electron accelerators, Cobalt 60 teletherapy units, and x-ray therapy equipment.
1.3
This Standard is not intended to apply to equipment, with the exception of lasers, that emits for its intended purpose ultraviolet, infrared, shortwave, or microwave radiation.
1.4
This Standard applies to equipment for (a) medical applications (diagnostic and therapeutic) in the treatment of human beings and animals; and (b) other applications (eg, nondestructive inspection and testing, sterilization of food, drugs, etc).
1.5
This Standard applies to and presents requirements for double¬insulated equipment.
1.6 This Standard does not include the special requirements for equipment to be used in hazardous locations, as defined in the Canadian Electrical Code, Part I. CAN/CSA-C22.2 No. 114-M90 - May 1990 - Page 15
1.7
This Standard does not include specific requirements for means to protect persons from the radiation emitted by equipment. Note: For statutory requirements respecting the design, construction, and functioning of radiation-emitting equipment, users of this Standard are referred to the Atomic Energy Control Act, the Radiation Emitting Devices Act, or the Food and Drugs Act, depending on the type of equipment. For details of these statutory requirements, users should contact: Atomic Energy Control Board P.O. Box 1046 Ottawa, Ontario KIP 5S9 Bureau of Radiation and Medical Devices Health Protection Branch Health and Welfare Canada Ottawa, Ontario KIA OL2
1.8
In this Standard, shall indicates a mandatory requirement; should indicates a recommendation, or that which is advised but not mandatory. Notes accompanying clauses do not include mandatory or alternative requirements. The purpose of a note accompanying a clause is to separate from the text explanatory or informative material that is not properly a part of the Standard.
Notes to figures and tables are considered to be part of the figure or table and are written as mandatory requirements. Terms that have been defined in Clause 2 appear throughout the Standard in capital letters.
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