GreatNorthCollective/greatnorth-canada-federal-laws-text huggingface dataset:
Radiation Emitting Devices Regulations — 15
15 Cabinet X-ray equipment, being X-ray generating devices, not including analytical X-ray equipment or baggage inspection X-ray devices, that have the X-ray tube permanently installed in a cabinet and are designed primarily for the examination of material, part or all of which is placed within the cabinet.
Radiation Emitting Devices Regulations — 1
1 In this Part, maximum test voltage means (a) 127 volts, if the television receiver is designed to operate from a 110-120 volt power source, or (b) 110 per cent of the maximum voltage from which the television receiver is designed to operate, if the television receiver is designed to operate otherwise than from a 110-120 volt power source; ( tension maximale d’essai ) service control means a control that is installed on a television receiver by the manufacturer thereof for the purpose of adjustment and that, under normal usage, is not accessible to the user of the receiver; ( commande interne ) user control means a control that is provided on or external to a television receiver by the manufacturer thereof for the purpose of adjustment and that for a fully assembled television receiver under normal usage, is accessible to the user. ( commande externe )
Radiation Emitting Devices Regulations — (a)
maximum test voltage means (a) 127 volts, if the television receiver is designed to operate from a 110-120 volt power source, or (b) 110 per cent of the maximum voltage from which the television receiver is designed to operate, if the television receiver is designed to operate otherwise than from a 110-120 volt power source; ( tension maximale d’essai )
Radiation Emitting Devices Regulations — Radiation Emitting Devices Regulations
service control means a control that is installed on a television receiver by the manufacturer thereof for the purpose of adjustment and that, under normal usage, is not accessible to the user of the receiver; ( commande interne )
Radiation Emitting Devices Regulations — Radiation Emitting Devices Regulations
user control means a control that is provided on or external to a television receiver by the manufacturer thereof for the purpose of adjustment and that for a fully assembled television receiver under normal usage, is accessible to the user. ( commande externe )
Radiation Emitting Devices Regulations — 2
2 (1) Every television receiver shall be designed and constructed in such a way that (a) under normal conditions of use, and (b) on failure or malfunction of any one component or subsequent failure or malfunction of other components caused by that failure or malfunction, it functions in accordance with the standards of functioning described in section 3 for as long as the receiver has its original components or has replacement components recommended by the manufacturer. (2) Without limiting the generality of subsection (1), the components of a receiver that emit X-rays shall have sufficient shielding to enable the receiver to comply with the standards of functioning set out in section 3. (3) Where the shielding required by subsection (2) necessitates the use of individual shields, such shields shall either (a) be non-removable, or interlocked; or (b) bear a radiation warning sign that is permanently affixed and clearly visible under the conditions of servicing, and cautions against operation of the receiver when the shield is removed. (4) Subject to subsection (6), every television receiver shall bear on the rear external surface of its cabinet or case, a permanent label that sets out, with respect to the receiver (a) the name and address of the manufacturer; (b) the model number; (c) the city and country of manufacture or a code by which that city and country are identified and the key to which is supplied by the manufacturer to the Minister before the sale of the receiver; (d) the month and year of manufacture, without abbreviation, with the year shown as a four-digit number; (e) the brand name of the receiver; (f) the chassis family designation; and (g) the serial number. (5) The permanent label required by subsection (4) shall be clearly visible at any time. (6) Where a television receiver is manufactured for sale under the trade name of a person who is not the manufacturer of the receiver, the trade name and the address of that person may, for the purposes of paragraph (4)(a), be substituted for the name and address of the manufacturer if the name and address of the manufacturer are permanently affixed to the inside of the cabinet or case of the receiver and are clearly visible under conditions of servicing. (7) and (8) [Revoked, SOR/94-40, s. 1]
Radiation Emitting Devices Regulations — 3
3 Every television receiver shall function in such a way that (a) when the receiver (i) is fully assembled, (ii) is used with any supply voltage up to the maximum test voltage, (iii) is used with any settings of the user controls and service controls, and (iv) displays a synchronous raster covering at least 60 per cent of the viewable screen area, the emission of ionizing radiation therefrom is such that the exposure rate of X-rays, when averaged over a period of five minutes, to an object having a 10 square centimetre cross section and centred at five centimetres from any accessible external surface of the television receiver does not exceed 0.5 milliroentgen per hour; and (b) when the receiver, without its cabinet or case, or any part of the chassis, cabinet or case, (i) is used with any supply voltage up to the maximum test voltage, (ii) is used with any settings of the user controls and service controls, and (iii) displays a synchronous raster covering at least 60 per cent of the viewable screen area, the emission of ionizing radiation therefrom is such that the exposure rate of X-rays, when averaged over a period of five minutes, to an object having a 10 square centimetre cross section and centred at 10 centimetres from the surface of any component of the receiver does not exceed 2.5 milliroentgen per hour.
Radiation Emitting Devices Regulations — 1
ectification type means the process by which the X-ray generator of dental X-ray equipment converts high voltage to X-ray tube voltage. ( type de redressement ) transportable , in relation to dental X-ray equipment, means that the equipment is constructed so that, once it is placed into service, it is capable of being moved from one place to another. ( transportable ) X-ray field means the area on a surface that is intersected by a radiation beam whose boundary is determined by the points where the air kerma drops to 25% of the air kerma at the centre of the area. ( champ de rayonnement X ) X-ray image receptor means a device that converts incident X-rays into a visible image or into a form that can be made into a visible image. ( récepteur d’image radiologique )
Radiation Emitting Devices Regulations — Radiation Emitting Devices Regulations
aluminum means aluminum that has a degree of purity of 99.9% or higher and a density of 2.70 g/cm 3 . ( aluminium )
Radiation Emitting Devices Regulations — Radiation Emitting Devices Regulations
aluminum equivalent means the attenuation equivalent of an object, expressed in thickness of aluminum. ( équivalent en aluminium )
Radiation Emitting Devices Regulations — Radiation Emitting Devices Regulations
coefficient of variation means the ratio of the estimated standard deviation to the mean value of a series of measurements, determined by the formula The coefficient of variation, determined by the formula “C equals S divided by X bar, which is also equal to one divided by X bar multiplied by, open square bracket, sum from i equals one to n, open parentheses, X sub i minus X bar, close parentheses, squared, divided by n minus one, close square bracket, to the power of one half”. where C is the coefficient of variation; S is the estimated standard deviation; X is the mean value of the measurements; X i is the value of the i th measurement; and n is the number of measurements. ( coefficient de variation )
Radiation Emitting Devices Regulations — Radiation Emitting Devices Regulations
dental volumetric reconstruction means reconstruction of the three-dimensional attenuation distribution of all or part of the irradiated volume from a series of two-dimensional projections that are produced by an X-ray beam on an X-ray image receptor moving around the head of a patient. ( reconstruction dentaire volumétrique )
Radiation Emitting Devices Regulations — Radiation Emitting Devices Regulations
deviation , in respect of any parameter of dental X-ray equipment, means the percentage error between the measured value and the value indicated either on the equipment or in the accompanying information. ( variation )
Radiation Emitting Devices Regulations — Radiation Emitting Devices Regulations
digital X-ray image receptor means an X-ray image receptor that has a conversion method which is electrically powered. The conversion method may include single-step direct conversion or multi-step indirect conversion. ( récepteur numérique d’image radiologique )
Radiation Emitting Devices Regulations — Radiation Emitting Devices Regulations
effective image reception area means the part of the image reception area that is configured to receive an X-ray pattern that can be processed for display or storage. ( surface réceptrice de l’image efficace )
Radiation Emitting Devices Regulations — Radiation Emitting Devices Regulations
extra-oral , in relation to dental radiography, means that the X-ray image receptor is located outside the oral cavity. ( extra-oral )
Radiation Emitting Devices Regulations — Radiation Emitting Devices Regulations
hand-held , in respect of transportable dental X-ray equipment, means that the equipment, once it is placed into service, is held in or supported by the hand. ( portatif )
Radiation Emitting Devices Regulations — Radiation Emitting Devices Regulations
intra-oral , in relation to dental radiography, means that all or part of the X-ray image receptor is located inside the oral cavity. ( intra-oral )
Radiation Emitting Devices Regulations — Radiation Emitting Devices Regulations
irradiation time means the duration of an irradiation, measured as the interval between the instant when the air kerma rate rises for the first time to a value of 50% of the peak value and the instant when it drops for the last time below 50% of the peak value. ( temps d’irradiation )
Radiation Emitting Devices Regulations — Radiation Emitting Devices Regulations
lead equivalent means the attenuation equivalent of an object, expressed in thickness of lead. ( équivalent en plomb )
Radiation Emitting Devices Regulations — (a)
loading factor means a factor the value of which influences the X-ray tube load. It includes the following: (a) in the case of an X-ray beam that is produced by the discharge of the capacitor through an X-ray tube, the X-ray tube voltage and the amount of capacitor charge; (b) in the case of a field emission device in which the emission of electrons from the cathode is due solely to the action of an electric field, the X-ray tube voltage and the number of pulses; and (c) in any other case, the X-ray tube voltage and either (i) the X-ray tube current and irradiation time, or (ii) the current time product. ( paramètre de charge )
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mode of operation means the technical state that is defined by a configuration of several predetermined loading factors and other settings for radiography or radioscopy, selectable simultaneously by the operation of a single control. ( mode de fonctionnement )
Radiation Emitting Devices Regulations — Radiation Emitting Devices Regulations
rectification type means the process by which the X-ray generator of dental X-ray equipment converts high voltage to X-ray tube voltage. ( type de redressement )
Radiation Emitting Devices Regulations — Radiation Emitting Devices Regulations
transportable , in relation to dental X-ray equipment, means that the equipment is constructed so that, once it is placed into service, it is capable of being moved from one place to another. ( transportable )
Radiation Emitting Devices Regulations — Radiation Emitting Devices Regulations
X-ray field means the area on a surface that is intersected by a radiation beam whose boundary is determined by the points where the air kerma drops to 25% of the air kerma at the centre of the area. ( champ de rayonnement X )
Radiation Emitting Devices Regulations — Radiation Emitting Devices Regulations
X-ray image receptor means a device that converts incident X-rays into a visible image or into a form that can be made into a visible image. ( récepteur d’image radiologique )
Radiation Emitting Devices Regulations — 2
General requirements 2 The manufacturer, distributor and importer must ensure that all of the following information accompanies each piece of dental X-ray equipment: (a) the manufacturer’s name and civic address, and its postal address if different; (b) the model designation of the equipment; (c) the installation instructions; (d) any radiological safety procedures and additional precautions that are necessary because of any unique features of the equipment; (e) instructions for use that include (i) a description of the influence of the main settings or selections that are available to the operator on the radiation dose to the patient, (ii) if protection of the operator is affected by distance from the equipment, information on the impact of distance on the radiation dose, and (iii) all information necessary to minimize the operator’s exposure to radiation; (f) maintenance instructions; (g) procedures for quality control testing to be performed on the equipment, including how often the tests are to be performed and the acceptance criteria; (h) for each X-ray tube assembly, (i) the nominal focal spot sizes, (ii) the cooling curves for the anode and for the X-ray tube housing, (iii) the X-ray tube rating charts, and (iv) the focal spot position; (i) the duty cycles, its rectification type and its generator rating; (j) the nominal line voltage, the maximum line current and the line voltage regulation that are necessary to operate the equipment at the maximum line current; (k) the loading factors that constitute the maximum line current condition for the X-ray generator; (l) the recommended loading factors for each patient size; (m) when combinations of loading factors are indicated on the control panel by either a single reference to the combination or the value of only one of the loading factors that makes up the combination, the values of all the loading factors for each combination; (n) if the equipment can operate in automatic exposure control mode, (i) the accuracy limits of the automatic exposure control, (ii) the nominal shortest irradiation time in that mode, and (iii) the reproducibility of the air kerma relative to the range of loading factors, as the loading factors are adjusted by the automatic exposure control; (o) if the equipment can operate in a mode other than automatic exposure control mode, the operating range and the maximum deviation for any setting within the operating range for each loading factor; (p) if the equipment is battery-powered, the minimum state of charge that is necessary for it to operate; (q) if removable protective devices are specified for use with the equipment by the manufacturer, information about their effectiveness, application and use; (r) if dosimetric indications are displayed on the equipment, information and instructions on how to check and maintain their accuracy; and (s) for transportable equipment, recommendations for secure storage of the equipment against theft and unauthorized use.
Radiation Emitting Devices Regulations — 3
Additional requirements — intra-oral equipment 3 In addition to the requirements set out in section 2, the manufacturer, distributor and importer must ensure that all of the following additional information accompanies each piece of intra-oral dental X-ray equipment: (a) the shape and dimensions of the exit field; (b) in the case of equipment that has a digital X-ray image receptor, (i) a description of the minimum performance criteria for the device that is used to display the images for diagnostic purposes, (ii) the nominal X-ray image receptor air kerma range that is needed for the intended use, and (iii) recommendations for typical loading factors at specified distances between the focal spot and the skin to achieve the air kerma referred to in subparagraph (ii); (c) the method by which the distance between the focal spot and the skin can be determined using the indicator specified in paragraph 7 (f); (d) if the air kerma is indicated on the equipment, the maximum deviation; (e) if the air kerma is not indicated on the equipment, (i) the air kerma at a given distance from the focal spot for every selectable combination of loading factors, and (ii) the maximum deviation of the air kerma; (f) a method to calculate the dose area product using the air kerma and the exit field size; and (g) in the case of hand-held equipment, (i) values for the leakage radiation at the operator’s position and the method to assess the leakage radiation, (ii) guidance on how to avoid image degradation caused by motion of the X-ray source assembly during loading and the methods to assess the degradation, and (iii) the designation of a significant zone of occupancy, as follows: (A) dimensions of at least 60 cm x 60 cm with a height of at least 200 cm, (B) a drawing that indicates the boundaries of the zone in relation to clearly recognizable features of the equipment, (C) at least one profile of stray radiation in the zone with respect to the height above the floor — under representative operating conditions indicated — and that includes the point that receives the highest dose, and (D) a description of the testing methodology used to determine the profiles of stray radiation, including instructions for achieving the loading factors used in the testing if they are controlled only by an automatic control system.
Radiation Emitting Devices Regulations — 4
Additional requirements — extra-oral equipment 4 In addition to the requirements set out in section 2, the manufacturer, distributor and importer must ensure that all of the following additional information accompanies each piece of extra-oral dental X-ray equipment: (a) a description of the geometric relationship between the focal spot, X-ray beam dimensions, patient position and image reception area; (b) if the air kerma is indicated on the equipment, the maximum deviation; (c) if the air kerma is not indicated on the equipment, (i) the air kerma at the entrance of the X-ray image receptor for every selectable combination of loading factors, and (ii) the maximum deviation of the air kerma; (d) the maximum deviation of the dose area product; (e) instructions on how to identify the location and dimensions of the effective image reception area; (f) for equipment in which any of the loading factors set out in items 1 to 3 and 5, column 1, of the table to subsection 30 (1) vary during an irradiation, instructions on how to measure the deviation and on how to compare it with the maximum deviation set out in column 2 of that table; and (g) if a precalculated or measured current time product is indicated on the equipment, the lowest current time product or the combinations of loading factors that result in the lowest current time product.
Radiation Emitting Devices Regulations — 5
Presentation 5 The manufacturer, distributor and importer must ensure that all information that is required by this Part to be displayed on dental X-ray equipment is set out in a permanent, clear and legible manner on the specified surface of the equipment when it is fully assembled for use.
Radiation Emitting Devices Regulations — 6
Function of controls 6 The manufacturer must ensure that all controls, warning lights and other indicators on the control panel are clearly labelled as to their function.
Radiation Emitting Devices Regulations — 7
Displayed information 7 The manufacturer must ensure that all of the following information is displayed on dental X-ray equipment: (a) on the external surface of the control panel, (i) a statement that unauthorized use of the equipment is prohibited, (ii) a warning that hazardous X-rays are emitted when the equipment is in use, and (iii) one of the X-ray warning symbols set out in section 8 ; (b) on an external surface of the equipment, (i) the name of its manufacturer, (ii) its model designation, (iii) its serial number, (iv) the date of its manufacture, and (v) the country where it was manufactured; (c) on or near the external surface of the control panel — when combinations of loading factors are indicated on the control panel by either a single reference to the combination or the value of only one of the loading factors that makes up the combination — the values of all the loading factors for each combination; (d) on the external surface of the X-ray source assembly, with respect to the X-ray tube, (i) the name of its manufacturer, (ii) the model designation, (iii) its serial number, and (iv) the country of its manufacture; (e) on the external surface of the X-ray source assembly, the permanent filtration of the X-ray source assembly, expressed at a specified X-ray tube voltage either in millimetres of aluminum equivalent or as the thickness of any other material, together with its chemical symbol; (f) on the external surface of the X-ray source assembly, a mark that indicates the location along the X-ray beam axis of the focal spot on the anode target; (g) on the surface of any detachable beam-limiting device, (i) the name of its manufacturer, (ii) its model designation, (iii) its serial number, (iv) its quality equivalent filtration, if it is more than 0.2 mm aluminum equivalent, expressed at a specified X-ray tube voltage either in millimetres of aluminum equivalent or as the thickness of another material together with its chemical symbol, and (v) in the case of intra-oral equipment, its exit field size; (h) on the external surface of every fixed layer of material in the path of the X-ray beam incident on the patient — excluding any added filters and non-removable materials in the X-ray tube assembly — the quality equivalent filtration, if it is more than 0.2 mm aluminum equivalent, expressed at a specified X-ray tube voltage either in millimetres of aluminum equivalent or as the thickness of another material together with its chemical symbols; and (i) on the external surface of the X-ray tube housing of hand-held intra-oral equipment, the words “WARNING: Hand-held operation increases operator radiation exposure due to proximity. See manufacturer safety information.” « ATTENTION : L’utilisation de l’appareil en mode portatif augmente l’exposition de l’opérateur au rayonnement en raison de la proximité. Consultez les renseignements de sécurité du fabricant. »
Radiation Emitting Devices Regulations — Radiation Emitting Devices Regulations
“WARNING: Hand-held operation increases operator radiation exposure due to proximity. See manufacturer safety information.”
Radiation Emitting Devices Regulations — Radiation Emitting Devices Regulations
« ATTENTION : L’utilisation de l’appareil en mode portatif augmente l’exposition de l’opérateur au rayonnement en raison de la proximité. Consultez les renseignements de sécurité du fabricant. »