GreatNorthCollective/greatnorth-canada-federal-laws-text huggingface dataset:
Radiation Emitting Devices Regulations — 8
Warning symbol 8 The X-ray warning symbol must have the following characteristics: (a) it must be displayed in two contrasting colours; (b) it must be visible and identifiable from a distance of 1 m; (c) it must be at least 2 cm high and at least 2 cm wide; (d) it must bear the words “CAUTION: X-RAYS — ATTENTION : RAYONS X ”; and (e) it must conform to one of the following: (i) the X-ray warning symbol: Warning symbol consisting of an inverted triangle that contains a tube with a circle in the middle of it from which three dashed lines emerge. (ii) the symbol ISO 361 in the report of the International Electrotechnical Commission entitled Graphical symbols for electrical equipment in medical practice , Publication IEC TR 60878: 2015, Third Edition, illustrated as follows: Warning symbol consisting of three black blades around a black circle. (iii) the symbol ISO 7010-W003 in the report of the International Electrotechnical Commission entitled Graphical symbols for electrical equipment in medical practice , Publication IEC TR 60878: 2015, Third Edition, illustrated as follows: Warning symbol consisting of a yellow triangle bordered by a black line and containing three black blades around a black circle.
Radiation Emitting Devices Regulations — 9
Control panel 9 The control panel of dental X-ray equipment must have all of the following features: (a) a visual indicator that warns the operator when one further actuation of a control will initiate the emission of X-rays; (b) a visual indicator that warns the operator when X-rays are being emitted and that is clearly visible during the emission; (c) if the equipment can emit X-rays while not in automatic exposure control mode, controls and visual indicators that enable the operator to select the loading factors or mode of operation before initiation of the irradiation; (d) if more than one X-ray source assembly is controlled by the same control panel, a visual indicator that shows, before initiation of the irradiation, which of the X-ray source assemblies is connected and ready to emit X-rays; (e) if the equipment allows for the selection of added filters by remote control or an automatic system, a visual indicator that shows which filter has been selected; (f) if the equipment is battery-powered, a visual indicator that shows whether the battery is adequately charged for the proper operation of the equipment; (g) for extra-oral equipment, an indicator that displays the dose area product; and (h) for extra-oral equipment, an indicator that displays the air kerma at the entrance of the X-ray image receptor, unless the air kerma is already provided in the accompanying information required by section 4 .
Radiation Emitting Devices Regulations — 10
Irradiation switch — functions 10 (1) Every irradiation switch of dental X-ray equipment must enable all of the following functions: (a) to initiate and to end an irradiation; (b) to permit the emission of X-rays only when the operator exerts continuous pressure on the switch; (c) to operate in a way that it is not possible to initiate an irradiation without first releasing the switch by which the previous irradiation was initiated; and (d) except in the case of hand-held intra-oral equipment, to permit the operator to stand at least 2 m from the X-ray source assembly when the X-ray tube is energized. Hand-held intra-oral equipment (2) Hand-held intra-oral equipment must also be equipped with a second irradiation switch, whether attached or remote, that gives the operator the option to stand at least 2 m from the X-ray source assembly when the equipment is supported on a stand.
Radiation Emitting Devices Regulations — 11
Protected area 11 Dental X-ray equipment, except transportable equipment, must have a means to permit initiation of an irradiation by the operator from an area that is protected from radiation by structural shielding or distance.
Radiation Emitting Devices Regulations — 12
Audible signal 12 Dental X-ray equipment must emit a signal, clearly audible to the operator, that indicates the end of an irradiation.
Radiation Emitting Devices Regulations — 13
Line voltage fluctuations 13 Dental X-ray equipment must have a means appropriate to its rectification type to compensate for variations in X-ray tube voltage that are caused by line voltage fluctuations.
Radiation Emitting Devices Regulations — 14
X-ray tube 14 The X-ray tube of dental X-ray equipment must be securely affixed to and aligned within the X-ray tube housing.
Radiation Emitting Devices Regulations — 15
X-ray source assembly 15 The X-ray source assembly of dental X-ray equipment must maintain its required position or trajectory without drift or vibration during operation.
Radiation Emitting Devices Regulations — 16
Multiple X-ray source assemblies 16 If more than one X-ray source assembly of dental X-ray equipment is controlled by the same control panel, the equipment must have a visual indicator on or near each X-ray tube housing that shows which of the X-ray source assemblies has been selected.
Radiation Emitting Devices Regulations — 17
Filtration 17 (1) Dental X-ray equipment must have radiation-absorbing filters that meet the following requirements: (a) the filters must be securely affixed to the exit port of the X-ray tube housing or to the beam-limiting device, or to both; and (b) the filters must provide the following degree of attenuation of the X-ray beam: (i) for each X-ray tube voltage peak value set out in column 1 of the table to this subsection, a first half-value layer of aluminum that is not less than the value set out in column 2, and (ii) in any other case, a first half-value layer of aluminum that is not less than the value obtained by linear interpolation or extrapolation from that table. TABLE Column 1 Column 2 Item X-ray Tube Voltage — Peak Value (kV) First Half-value Layer of Aluminum (mm) 1 60 2.2 2 70 2.5 3 80 2.9 4 90 3.2 5 100 3.6 6 110 3.9 7 120 4.3 8 130 4.7 9 140 5.0 10 150 5.4 Total filtration — intra-oral equipment (2) Despite paragraph (1)(b), if intra-oral dental X-ray equipment operates at a maximum nominal X-ray tube voltage of 70 kV or less, it may have a total filtration of at least 1.5 mm aluminum equivalent.
Radiation Emitting Devices Regulations — 18
Automatic exposure control 18 Dental X-ray equipment that has an automatic exposure control must have the following features: (a) a means to automatically end the irradiation when, (i) in the case of extra-oral equipment, either (A) the product of the X-ray tube voltage, X-ray tube current and irradiation time exceeds 64 kJ per irradiation, or (B) the current time product exceeds 640 mAs per irradiation, and (ii) in the case of intra-oral equipment, either (A) the product of the X-ray tube voltage, X-ray tube current and irradiation time exceeds 3.2 kJ per irradiation, or (B) the current time product exceeds 32 mAs per irradiation; (b) a visual indicator or audible signal to warn the operator that the irradiation has ended because one of the limits set out in paragraph (a) has been reached; and (c) a reset control that must be activated manually once one of the limits set out in paragraph (a) has been reached and before another irradiation under automatic exposure control can be initiated.
Radiation Emitting Devices Regulations — 19
Minimum distance — focal spot to skin 19 The minimum distance between the focal spot and the skin must be (a) 15 cm, in the case of extra-oral equipment; and (b) 20 cm, in the case of intra-oral equipment.
Radiation Emitting Devices Regulations — 20
Maximum deviation — focal spot to image receptor 20 If the distance between the focal spot and the X-ray image receptor of extra-oral dental X-ray equipment is adjustable, the equipment must have a visual indicator that shows the distance that is selected and that has a maximum deviation of 5%.
Radiation Emitting Devices Regulations — 21
Beam-limiting device — extra-oral equipment 21 (1) Extra-oral dental X-ray equipment must have a beam-limiting device that meets the following requirements: (a) when used for dental volumetric reconstruction with a circular image reception area, the device must operate so that (i) the X-ray field does not exceed the boundary of the effective image reception area by more than 2 cm, measured along any diameter, and (ii) at least 90% of the area of the X-ray field overlaps the effective image reception area; (b) when used for dental volumetric reconstruction with a rectangular image reception area, the device must operate so that (i) along each of the two axes of the image reception area, the edges of the X-ray field do not exceed the corresponding edges of the effective image reception area by more than 2 cm or 3% of the indicated distance between the focal spot and the image receptor, whichever is larger, when the image reception plane is perpendicular to the X-ray beam axis, and (ii) the sum of the discrepancies on both axes does not exceed 3 cm or 4% of the indicated distance between the focal spot and the X-ray image receptor, whichever is larger; (c) when used for projection radiography, the device must operate so that the X-ray field does not exceed the boundary of the effective image reception area; and (d) when used for narrow beam scanning radiography, the device must operate so that (i) along the axis of the image reception area that is parallel to the direction of the scanning, the X-ray field does not exceed the boundary of the effective image reception area by more than 1 mm on each side, and (ii) along the axis of the image reception area that is perpendicular to the direction of the scanning, the X-ray field does not exceed boundary of the effective image reception area. Beam-limiting device — intra-oral equipment (2) Intra-oral dental X-ray equipment must have a beam-limiting device that meets the following requirements: (a) the device limits the X-ray field to a circle of not more than 6 cm diameter, measured at the point at which the beam exits the equipment; (b) if the device has an optional means to limit the exit field to a rectangular shape, it must operate so that the rectangle fits inside that circle; (c) if the device has a rectangular exit field, it must operate so that the exit field can rotate with respect to the X-ray beam axis; and (d) in the case of equipment that has an integrated direct digital X-ray image receptor, the device has a means to limit the X-ray field to a rectangular shape that does not exceed the boundary of the effective image reception area by more than 1 cm in the diagonal.
Radiation Emitting Devices Regulations — 22
Incremental settings 22 When irradiation times are 0.08 s or greater, the range of settings for the X-ray tube current, irradiation time or current time product of dental X-ray equipment must be in increments that are not greater than the decimal multiples and submultiples of 1.00, 1.25, 1.60, 2.00, 2.50, 3.20, 4.00, 5.00, 6.30 and 8.00.
Radiation Emitting Devices Regulations — 23
Modes of operation 23 Dental X-ray equipment that has more than one mode of operation must be constructed in accordance with the following requirements: (a) in the case of extra-oral equipment that does not have an integrated direct digital X-ray image receptor, the step size of the adjustment between adjacent settings of the current time product must not be greater than 1.6 mAs; and (b) in the case of intra-oral equipment, (i) the step size of the adjustment between adjacent settings of the current time product must not be greater than 1.6 mAs, and (ii) the ratio of the maximum to minimum current time product settings must be at least 4:1.
Radiation Emitting Devices Regulations — 24
Current time product 24 For each selectable X-ray tube voltage of intra-oral dental X-ray equipment, the ratio of the maximum to minimum current time product settings must be at least 16:1.
Radiation Emitting Devices Regulations — 25
Primary shielding 25 Extra-oral dental X-ray equipment must have primary protective shielding that completely overlaps the X-ray field and that provides the following minimum attenuation: (a) 0.5 mm lead equivalent, in the case of a nominal X-ray tube voltage of 90 kV or less; and (b) 2 mm lead equivalent, in the case of a nominal X-ray tube voltage of more than 90 kV.
Radiation Emitting Devices Regulations — 26
Attenuation equivalent 26 All parts of extra-oral dental X-ray equipment that are located in the path of the X-ray beam between the patient and the X-ray image receptor must, when taken together, have an attenuation of not more than 1.2 mm aluminum equivalent, as determined at the highest X-ray tube voltage of the equipment.
Radiation Emitting Devices Regulations — 27
Hand-held intra-oral equipment 27 Hand-held intra-oral dental X-ray equipment must have all of the following features: (a) a permanently affixed backscatter shield that has an attenuation of at least 0.25 mm lead equivalent, as determined at a nominal X-ray tube voltage of 70 kV; (b) a means to prevent unauthorized operation; and (c) a means to allow the equipment to be supported in a way that it maintains its position so that it is not necessary for the operator to hold the equipment during operation.
Radiation Emitting Devices Regulations — 28
X-ray tube voltage 28 The minimum nominal X-ray tube voltage of dental X-ray equipment must be at least 60 kV.
Radiation Emitting Devices Regulations — 29
Functioning requirements 29 Dental X-ray equipment must function in accordance with sections 30 to 35 under the following conditions: (a) the unloaded line voltage must not vary by more than 1% of its nominal value; and (b) the line voltage must be regulated so that it does not vary by more than 6% when the line is fully loaded at the maximum rated line current of the equipment.
Radiation Emitting Devices Regulations — 30
Loading factors 30 (1) Subject to subsection (2), for any combination of loading factors, the measured value of a loading factor set out in column 1 of the table to this subsection must not deviate from the indicated value by more than the amount set out in column 2. TABLE Column 1 Column 2 Item Loading Factor Maximum Deviation 1 X-ray tube voltage 10% 2 X-ray tube current 20% 3 Irradiation time for extra-oral dental X-ray equipment 5% + 50 ms 4 Irradiation time for intra-oral dental X-ray equipment 5% or 20 ms, whichever is greater 5 Current time product for extra-oral dental X-ray equipment 10% + 0.2 mAs Exception — intra-oral equipment (2) In the case of intra-oral dental X-ray equipment that has a one-peak high-voltage generator, the maximum deviation set out in item 4, column 2, of the table to subsection (1) does not apply when the irradiation time is shorter than 0.1 s.
Radiation Emitting Devices Regulations — 31
Coefficient of variation — air kerma 31 (1) For any combination of loading factors of dental X-ray equipment, the coefficient of variation of any five consecutive air kerma measurements — taken at the same point along the X-ray beam axis within a one-hour period — must be 0.05 or less. Internally powered equipment (2) Dental X-ray equipment that is internally powered must meet the requirement set out in subsection (1) over the whole range of usable charging levels of the internal supply.
Radiation Emitting Devices Regulations — 32
Maximum deviation — air kerma 32 The maximum deviation of the air kerma for dental X-ray equipment must not exceed 50%.
Radiation Emitting Devices Regulations — 33
Maximum deviation — dose area product 33 The maximum deviation of the dose area product for extra-oral dental X-ray equipment must not exceed 50%.
Radiation Emitting Devices Regulations — 34
Air kerma — linearity 34 (1) Subject to subsection (2), for any selected value of X-ray tube voltage and over the whole range of current time product settings, for any two settings of the current time product that do not differ by more than a factor of 2, the quotients of the average of the air kerma measurements divided by the corresponding indicated current time product must not differ by more than 0.10 times their sum, as determined by the following formula, where X is the quotient of the average of the air kerma measurements divided by the indicated current time product, calculated at each of the two settings of the current time product: |X 1 – X 2 | ≤ 0.1(X 1 + X 2 ) Exception — intra-oral equipment (2) In the case of intra-oral dental X-ray equipment that has a one-peak high-voltage generator, the shortest irradiation time in the range of current time product settings is 80 ms.
Radiation Emitting Devices Regulations — 35
Leakage radiation — loading state 35 (1) Leakage radiation from the X-ray source assembly of dental X-ray equipment must not exceed the following air kerma rate when the equipment is operated at the nominal X-ray tube conditions of loading that correspond to the maximum specified energy input in one hour: (a) in the case of extra-oral equipment, 1.0 mGy/h; and (b) in the case of intra-oral equipment, (i) 1.5 µGy/h for hand-held intra-oral equipment, and (ii) 0.25 mGy/h for all other intra-oral equipment. Detection area (2) For the purpose of subsection (1), the air kerma rate must be averaged over a detection area of 100 cm 2 — of which no linear dimension is greater than 20 cm — that is 1 m from the focal spot. Leakage radiation — extra-oral equipment in non-loading state (3) In the case of extra-oral dental X-ray equipment that is not in the loading state, the leakage radiation from the X-ray source assembly must not exceed an air kerma rate of 20 µGy/h. Detection area (4) For the purpose of subsection (3), the air kerma rate must be averaged over a detection area of 10 cm 2 — of which no linear dimension is greater than 5 cm — that is 5 cm from any accessible surface of the equipment.
Radiation Emitting Devices Regulations — 1
1 In this Part and in items 3 of Schedule I, cavity means a structure that encloses and confines a microwave field; ( cavité ) commercial microwave oven means a microwave oven for use (a) in a restaurant, cafeteria or other commercial establishment, (b) in an industrial establishment, or (c) in or with a vending machine; ( four à micro-ondes commercial ) control panel means the portion of the external surface of a microwave oven on which the user controls are mounted; ( panneau de commande ) conveyor means a device that transports material into or within a cavity; ( convoyeur ) door , with respect to a cavity, means a movable or removable structure that in the closed position is designed to prevent access to the cavity; ( porte ) effective aperture [Revoked, SOR/84-930, s. 1] external surface , with respect to a microwave oven, means the outside surface of the cabinet or other enclosure of the oven and includes the plane of any exit or entry port for conveyorized ovens; ( surface externe ) interlock means a component or set of components that prevents the generation of microwave power when access to a cavity is possible; ( enclenchement ) leakage radiation means any radiation transmitted outside the external surface; ( rayonnement de fuite ) microwave means an electromagnetic wave with frequency in the range 0.010 GHz to 300 GHz; ( micro-onde ) outer enclosure means a metal or plastic cover that encloses the mechanical and electronic parts of a microwave oven that, under normal conditions of use, are not accessible to the user of the oven; ( enceinte externe ) response time means the time period in which a radiation meter indicator reaches ninety per cent of its final steady state reading when subjected to a stepped input signal; ( temps de réponse ) service control means a control that is provided by the manufacturer for the purpose of adjustment of the microwave oven and that, under normal conditions of use, is not accessible to the user of the oven; ( commande interne ) stirrer means the structure designed to distribute the microwave energy within a cavity; ( agitateur ) user control means a control that is provided by the manufacturer for the purpose of operation of the microwave oven and that, under normal conditions of use, is accessible to the user of the oven; ( commande externe ) water equivalent [Revoked, SOR/79-920, s. 1] waveguide means a metal tube or duct for transmitting microwave energy. ( guide d’ondes )
Radiation Emitting Devices Regulations — Radiation Emitting Devices Regulations
cavity means a structure that encloses and confines a microwave field; ( cavité )
Radiation Emitting Devices Regulations — (a)
commercial microwave oven means a microwave oven for use (a) in a restaurant, cafeteria or other commercial establishment, (b) in an industrial establishment, or (c) in or with a vending machine; ( four à micro-ondes commercial )
Radiation Emitting Devices Regulations — Radiation Emitting Devices Regulations
control panel means the portion of the external surface of a microwave oven on which the user controls are mounted; ( panneau de commande )
Radiation Emitting Devices Regulations — Radiation Emitting Devices Regulations
conveyor means a device that transports material into or within a cavity; ( convoyeur )
Radiation Emitting Devices Regulations — Radiation Emitting Devices Regulations
door , with respect to a cavity, means a movable or removable structure that in the closed position is designed to prevent access to the cavity; ( porte )
Radiation Emitting Devices Regulations — Radiation Emitting Devices Regulations
effective aperture [Revoked, SOR/84-930, s. 1]
Radiation Emitting Devices Regulations — Radiation Emitting Devices Regulations
external surface , with respect to a microwave oven, means the outside surface of the cabinet or other enclosure of the oven and includes the plane of any exit or entry port for conveyorized ovens; ( surface externe )
Radiation Emitting Devices Regulations — Radiation Emitting Devices Regulations
interlock means a component or set of components that prevents the generation of microwave power when access to a cavity is possible; ( enclenchement )
Radiation Emitting Devices Regulations — Radiation Emitting Devices Regulations
leakage radiation means any radiation transmitted outside the external surface; ( rayonnement de fuite )
Radiation Emitting Devices Regulations — Radiation Emitting Devices Regulations
microwave means an electromagnetic wave with frequency in the range 0.010 GHz to 300 GHz; ( micro-onde )
Radiation Emitting Devices Regulations — Radiation Emitting Devices Regulations
outer enclosure means a metal or plastic cover that encloses the mechanical and electronic parts of a microwave oven that, under normal conditions of use, are not accessible to the user of the oven; ( enceinte externe )
Radiation Emitting Devices Regulations — Radiation Emitting Devices Regulations
response time means the time period in which a radiation meter indicator reaches ninety per cent of its final steady state reading when subjected to a stepped input signal; ( temps de réponse )
Radiation Emitting Devices Regulations — Radiation Emitting Devices Regulations
service control means a control that is provided by the manufacturer for the purpose of adjustment of the microwave oven and that, under normal conditions of use, is not accessible to the user of the oven; ( commande interne )
Radiation Emitting Devices Regulations — Radiation Emitting Devices Regulations
stirrer means the structure designed to distribute the microwave energy within a cavity; ( agitateur )
Radiation Emitting Devices Regulations — Radiation Emitting Devices Regulations
user control means a control that is provided by the manufacturer for the purpose of operation of the microwave oven and that, under normal conditions of use, is accessible to the user of the oven; ( commande externe )
Radiation Emitting Devices Regulations — Radiation Emitting Devices Regulations
water equivalent [Revoked, SOR/79-920, s. 1]
Radiation Emitting Devices Regulations — Radiation Emitting Devices Regulations
waveguide means a metal tube or duct for transmitting microwave energy. ( guide d’ondes )