GreatNorthCollective/greatnorth-canada-federal-laws-text huggingface dataset:
Radiation Emitting Devices Regulations — 6
6 Diagnostic X-ray equipment must have (a) if more than one X-ray tube is controlled by one control panel, (i) a visual indicator on or near each X-ray tube housing that shows that the X-ray tube to which the indicator applies is connected and ready to be energized, and (ii) a visual indicator on the control panel that shows which of the X-ray tubes are connected and ready to be energized; (b) a means, appropriate to the rectification type of the equipment, to compensate for variations in X-ray tube voltage caused by line voltage fluctuations; (c) a visual or audible indicator that warns the operator when the variation in line voltage exceeds the rate set out in subsection 23(2) or a mechanism that, in that event, prevents X-rays from being emitted; (d) on the control panel (i) a warning light that indicates when the equipment is ready to be energized, (ii) a second warning light that indicates when X-rays are being emitted, (iii) if an automatic exposure control is provided, a visual indicator showing when that mode of operation is selected, and (iv) if the automatic exposure control mode is not selected or does not exist, controls and visual indicators that enable the operator to select the loading factors before an irradiation; (e) if the equipment is battery powered, a visual indicator on the control panel showing whether the battery is adequately charged for the proper operation of the equipment; (f) a mechanism to initiate and terminate an irradiation; (g) an audible signal to indicate the termination of an irradiation; (h) in the case of equipment other than mammography equipment, if an X-ray source assembly has a permanent inherent filtration of 0.5 mm aluminum equivalent or less, a means to add additional filtration; (i) if the equipment moves around a patient by remote control, an emergency stop switch that immediately terminates both the motion of the equipment and the emission of X-rays; (j) a beam limiting device; and (k) for equipment that operates within a range set out in column 1 of an item of the table to this paragraph, radiation filters that result in a measured half-value layer of aluminum of not less than (i) for each X-ray tube voltage set out in column 2 of that item, the half-value layer set out in column 3 of that item, or (ii) in any other case, the half-value layer obtained by linear interpolation or extrapolation from that table. TABLE TO PARAGRAPH 6 (k) Minimum Half-Value Layer of Aluminum Column 1 Column 2 Column 3 Item Operating Range for Normal Use (kV) X-ray Tube Voltage (kV) Half-value Layer of Aluminum (mm) 1 50 or less (a) 30 0.3 (b) 40 0.4 (c) 50 0.5 2 50 or more but not more than 70 (a) 50 1.2 (b) 60 1.3 (c) 70 1.5 3 70 or more (a) 70 2.1 (b) 80 2.3 (c) 90 2.5 (d) 100 2.7 (e) 110 3.0 (f) 120 3.2 (g) 130 3.5 (h) 140 3.8 (i) 150 4.1
Radiation Emitting Devices Regulations — 7
7 (1) An irradiation switch for diagnostic X-ray equipment must (a) permit the emission of X-rays only when the operator exerts continuous pressure on the switch; (b) in the case of a foot switch, prevent the emission of any unintended X-rays when it is overturned; and (c) in the case of mobile equipment, permit the operator to stand at least 3 m from the X-ray source when the X-ray tube is energized. (2) The controlling timer for diagnostic X-ray equipment must (a) automatically terminate an irradiation (i) on completion of a preset irradiation time, (ii) on attainment of a preset current time product value, or (iii) on completion of a preset number of X-ray pulses; (b) permit the operator to terminate an irradiation at any time; (c) automatically reset itself to its original setting or to zero on termination of an irradiation; and (d) prevent the initiation of irradiation when the timer is set at zero, at the “off” position or at an unmarked setting.
Radiation Emitting Devices Regulations — 8
8 (1) In the case of diagnostic X-ray equipment, other than mammography equipment, when an object set out in column 1 of an item of the table to this subsection is positioned between the patient and the X-ray image receptor, the aluminum equivalent of the object shall not exceed the amount set out in column 2 of that item, as determined using an X-ray beam that (a) is generated at an X-ray tube voltage of 100 kV; (b) has a maximum X-ray tube voltage ripple of 10%; and (c) has a half-value layer of aluminum of 3.7 mm. TABLE TO SUBSECTION 8(1) Non-Mammography Equipment — Maximum Aluminum Equivalent of Interpositioned Objects Column 1 Column 2 Item Object Maximum Aluminum Equivalent (mm) 1 Front panel of cassette holder (total of all layers) 1.2 2 Front panel of film changer (total of all layers) 1.2 3 Cradle 2.3 4 Fixed patient support without an articulated joint 1.2 5 Movable patient support without an articulated joint, including any fixed layers 1.7 6 Patient support with one articulated joint and a radiolucent panel and 1.7 7 Patient support with two or more articulated joints and a radiolucent panel 2.3 8 Cantilevered patient support 2.3 (2) In the case of mammography equipment, when an object set out in column 1 of an item of the table to this subsection is positioned between the patient and the X-ray image receptor, the aluminum equivalent of the object shall not exceed the amount set out in column 2 of that item, as determined using an X-ray beam that (a) is generated at an X-ray tube voltage of 30 kV; (b) has a maximum X-ray tube voltage ripple of 10%; and (c) has a half-value layer of aluminum of 0.3 mm. TABLE TO SUBSECTION 8(2) Mammography Equipment — Maximum Aluminum Equivalent of Interpositioned Objects Column 1 Column 2 Item Object Maximum Aluminum Equivalent (mm) 1 Support table, including all layers 0.3 (3) For the purposes of subsections (1) and (2), any sensor used in automatic exposure control is a part of the X-ray image receptor.
Radiation Emitting Devices Regulations — 9
9 For diagnostic X-ray equipment, (a) the X-ray tube must be securely affixed to and aligned within the X-ray tube housing; (b) the radiation filters must be securely affixed to the exit port of the X-ray tube housing or beam limiting device, or both; and (c) the X-ray source assembly must maintain its required position or movement without drift or vibration during operation.
Radiation Emitting Devices Regulations — 10
10 Radiographic equipment that is equipped with an automatic exposure control must have (a) if the operating X-ray tube voltage is 50 kV or more, a minimum irradiation time capability that does not exceed (i) in the case of a field emission device that operates in pulse mode, the time equivalent to two pulses, or (ii) in the case of any other radiographic equipment, the greater of 1/60 s or the time required to deliver a current time product of 5 mAs; (b) a means to automatically terminate the irradiation when (i) if the operating X-ray tube voltage is less than 50 kV, the current time product exceeds 1,200 mAs per irradiation, or (ii) if the operating X-ray tube voltage is 50 kV or more, (A) the current time product exceeds 600 mAs per irradiation, or (B) the product of the X-ray tube voltage, X-ray tube current and irradiation time exceeds 60 kVAs per irradiation; and (c) when an irradiation under automatic exposure control terminates because the limits specified in paragraph (b) have been reached, (i) a visual indicator or audible signal that warns the operator of the termination, and (ii) a reset control that must be activated manually before another irradiation under automatic exposure control can be made.
Radiation Emitting Devices Regulations — 11
11 (1) General purpose radiographic equipment must have (a) a beam limiting device that (i) permits stepless adjustment of the size of the X-ray field, and (ii) when it is set at the smallest aperture and at a focal spot to image receptor distance of 1 m, has an X-ray field of 5 cm by 5 cm, or less; (b) an X-ray field indicator that uses light to visually define the X-ray field so that the limits of the X-ray field are visible under the ambient lighting conditions in an X-ray room; and (c) a means by which the operator may (i) determine when the X-ray beam axis is perpendicular to the image receptor plane, (ii) determine the focal spot to image receptor distance to within 2% of that distance, and (iii) align the centre of the X-ray field with the centre of the image reception area to within 2% of the focal spot to image receptor distance. (2) The X-ray field indicator referred to in paragraph (1)(b) must (a) illuminate on average at a minimum of 100 lx when measured from the lesser of (i) the distance of 1 m from the X-ray source, or (ii) the maximum focal spot to image receptor distance; (b) be circumscribed by the beam limiting device; (c) have as its perimeter the locus of points at which the illumination is one fourth of the maximum illumination in the area; and (d) when the X-ray beam axis is perpendicular to the image receptor plane, visually define the X-ray field within the following specifications, namely, (i) the separation between the perimeter of the visually defined field and that of the X-ray field does not exceed 2% of the focal spot to image receptor distance, and (ii) the dimensions of the X-ray field are indicated and are accurate to within 2% of the focal spot to image receptor distance.
Radiation Emitting Devices Regulations — 12
12 (1) General purpose radiographic equipment that has a positive beam limiting system must (a) permit stepless adjustment of the size of the X-ray field; (b) when it is set at the smallest aperture and at a focal spot to image receptor distance of 1 m, have an X-ray field of 5 cm by 5 cm, or less; (c) permit adjustment of the size of the X-ray field to dimensions that are smaller than those of the image reception area; (d) under the conditions of operation specified in subsection (2), (i) automatically adjust the dimensions of the X-ray field to the dimensions of the image reception area, or to a selected portion of that area, within 5 s after insertion of the image receptor, or (ii) prevent the emission of X-rays until the beam limiting device is manually adjusted so that (A) the dimensions of the X-ray field do not exceed those of the image reception area, or the selected portion of that area, by more than 3% of the focal spot to image receptor distance, and (B) the sum of the absolute values of the differences in the dimensions of the X-ray field and the image reception area, or the selected portion of that area, does not exceed 4% of the focal spot to image receptor distance; and (e) automatically revert to one of the requirements set out in paragraph (d) on any change to (i) the dimensions of the image reception area, or (ii) the focal spot to image receptor distance, if the change would result in failure to meet the requirements of paragraph (d). (2) For the purposes of paragraph (1)(d), the conditions of operation are as follows: (a) the image receptor is inserted into a permanently mounted cassette holder; (b) neither the length nor the width of the image reception area exceeds 50 cm; (c) the X-ray beam axis is within 3° of the perpendicular to the image receptor plane; (d) the X-ray beam axis is within 3° of (i) the horizontal plane, when the focal spot to image receptor distance is 90 cm or more but not more than 205 cm, or (ii) the vertical plane, when the focal spot to image receptor distance is 90 cm or more but not more than 130 cm; and (e) neither tomography nor stereoscopic radiography is being performed.
Radiation Emitting Devices Regulations — 13
13 (1) Subject to section 14, radiographic equipment, other than general purpose radiographic or mammography equipment, must have a fixed-aperture beam limiting device that, for the combination of image reception area and focal spot to image receptor distance described in subsection (2), (a) permits the centre of the X-ray field to be aligned with the centre of the image reception area to within 2% of the focal spot to image receptor distance; and (b) prevents the X-ray field from extending beyond any edge of the image reception area. (2) The fixed-aperture beam limiting device referred to in subsection (1) must display on its exterior surface a specified focal spot to image receptor distance and the dimensions of its image reception area at that distance.
Radiation Emitting Devices Regulations — 14
14 Mobile radiographic equipment that does not meet the requirements of section 13 must have (a) a beam limiting device that (i) permits stepless adjustment of the size of the X-ray field, and (ii) when it is set at the smallest aperture and at a focal spot to image receptor distance of 1 m, has an X-ray field of 5 cm by 5 cm, or less; (b) an X-ray field indicator referred to in paragraph 11(1)(b) that, when the X-ray beam axis is perpendicular to the image receptor plane, permits the alignment of the edges of the illuminated field with the edges of the X-ray field so that the difference between their edges does not exceed 2% of the focal spot to image receptor distance; and (c) a means to determine the focal spot to image receptor distance to an accuracy of 2% or less of that distance.
Radiation Emitting Devices Regulations — 15
15 (1) Mammography equipment must have (a) a beam limiting device that limits the size of the X-ray beam to prevent the X-ray field, at any focal spot to image receptor distance at which the equipment operates, from extending (i) more than 5 mm beyond the edge of the patient support next to the chest wall of the patient, and (ii) more than a distance equivalent to 2% of the focal spot to image receptor distance beyond any other edge of the image reception area; (b) an image receptor supporting device that (i) has protective shielding that limits the residual radiation in accordance with section 26, (ii) extends to the patient’s chest wall, and (iii) at every other edge, extends beyond the X-ray field by at least 1% of the focal spot to image receptor distance; and (c) a breast compression device that (i) is foot-actuated to start the compression, (ii) permits fine adjustment of motion during the compression, (iii) permits rapid decompression, (iv) has motion adjustment controls on both sides of the position for the patient, and (v) allows the portion of the compression plate in contact with the breast to be brought to within 10 mm of the surface of the patient support. (2) Mammography equipment that has a removable, fixed-aperture beam limiting device must display the following information on its external surface: (a) the dimensions of the image reception area; and (b) the focal spot to image receptor distance at which the beam limiting device must be used.
Radiation Emitting Devices Regulations — 16
16 Diagnostic X-ray equipment that has a spotfilm device must have (a) if the angle of the image receptor plane or of the X-ray source assembly is adjustable by the operator, a means to indicate when the X-ray beam axis is perpendicular to the image receptor plane; (b) when the X-ray beam axis is perpendicular to the image receptor plane, a mechanism that (i) when the X-ray field is larger than the selected portion of the image reception area, adjusts the dimensions of the field automatically to those of the selected portion of that area, (ii) when the X-ray field is smaller than the selected portion of the image reception area, permits the adjustment of the dimensions of the X-ray field, (iii) permits the perimeter of the X-ray field to be aligned with that of the selected portion of the image reception area so that (A) the dimensions of the X-ray field differ from the corresponding dimensions of the image reception area by a distance that does not exceed 3% of the focal spot to image receptor distance, and (B) the sum of the absolute values of the differences in the dimensions between the X-ray field size and the image reception area does not exceed 4% of the focal spot to image receptor distance, and (iv) permits the centre of the X-ray field to be aligned with the centre of the selected portion of the image reception area to within 2% of the focal spot to image receptor distance; (c) a mechanism for adjusting the X-ray field to dimensions that are smaller than those of the selected portion of the image reception area so that (i) when the mechanism is set at the smallest aperture and at the longest focal spot to image receptor distance, the X-ray field is 5 cm by 5 cm, or less, and (ii) the requirement set out in subparagraph (b)(iv) is met when the X-ray beam axis is perpendicular to the image receptor plane; and (d) if a means is provided for the operator to override a failure of the automatic X-ray field size adjustment, a visual indicator at the operator’s position that shows when the override is activated.
Radiation Emitting Devices Regulations — 17
17 Radiographic equipment, other than equipment described in sections 11 to 16, must have a beam limiting device that, when the axis of the X-ray beam is perpendicular to the image receptor plane, permits (a) the alignment of the centre of the X-ray field with the centre of the image reception area to within 2% of the focal spot to image receptor distance; and (b) the adjustment of the perimeter of the X-ray field so that the perimeter does not extend beyond that of the image reception area by more than 2% of the focal spot to image receptor distance.
Radiation Emitting Devices Regulations — 18
18 Radioscopic equipment must (a) have an X-ray image intensifier that includes protective shielding that (i) for any focal spot to image receptor distance, intercepts the entire cross section of the X-ray beam, (ii) intercepts the X-ray beam and scattered radiation from the image intensifier that would otherwise reach the operator, (iii) prevents the radioscopic X-ray tube from emitting X-rays unless the protective shielding is in place to intercept the X-ray beam, and (iv) sufficiently attenuates the X-rays transmitted through or scattered from the entrance window of the radioscopic imaging assembly to meet the requirements of section 32; (b) for mobile radioscopic equipment, have an X-ray image intensifier that is an integral part of the equipment or is interlocked in such a manner that its removal prevents X-rays from being produced; (c) for stationary radioscopic equipment, prevent the X-ray tube from producing X-rays when there is no image receptor in place to intercept the X-ray beam; (d) for stationary radioscopic equipment that is not equipped with remote control, (i) have protective shielding of at least 0.25 mm lead equivalent at 100 kV, such as overlapping hinged or sliding panels or protective drapes, to intercept the scattered radiation that would otherwise reach the operator, and (ii) the capability to remove the protective shielding referred to in subparagraph (i) when it interferes with the performance of diagnostic procedures; (e) have an irradiation switch that (i) requires continuous pressure by the operator for the entire period of an irradiation, and (ii) enables the operator to terminate the recording of serial radioscopic images at any time; (f) have a chronometer that (i) indicates the amount of time that the equipment has been emitting X-rays, and (ii) can be reset to zero or any other selected value; (g) have a positive beam limiting system that, when the X-ray beam axis is perpendicular to the image receptor plane, permits the alignment of the perimeter of the illuminated field with that of the X-ray field so that (i) the difference between the perimeters does not exceed a distance equivalent to 3% of the focal spot to image receptor distance, and (ii) the sum of the excess length and excess width does not exceed 4% of the focal spot to image receptor distance; (h) have visual indicators that continuously display the X-ray tube voltage and the X-ray tube current; and (i) have a device that limits the minimum focal spot to skin distance (i) for mobile radioscopic equipment, to 30 cm, (ii) for stationary radioscopic equipment, to 38 cm, (iii) for radioscopic equipment fitted with an X-ray image intensifier and used for special applications that require shorter focal spot to skin distances than the focal spot to skin distances specified in subparagraphs (i) and (ii), to 20 cm, or (iv) for small-format, low-intensity radioscopic equipment, to the distance at which the equipment delivers an air kerma rate of 50 mGy/min or an exposure rate of 5.75 R/min.
Radiation Emitting Devices Regulations — 19
19 Radioscopic equipment that is used for cineradiography must have visual indicators that continuously display the X-ray tube voltage and the X-ray tube current.
Radiation Emitting Devices Regulations — 20
20 A high-level irradiation control for radioscopic equipment must (a) be activated by a separate means that requires continuous pressure by the operator for it to emit X-rays; and (b) when it is in use, emit a continuous audible signal or an intermittent signal with silent periods of no longer than one second.
Radiation Emitting Devices Regulations — 21
21 Diagnostic X-ray equipment must function in accordance with the requirements set out in sections 22 to 32 during its operation under normal conditions of use.
Radiation Emitting Devices Regulations — 22
22 (1) The definitions in this subsection apply in this section. coefficient of variation means the ratio of the estimated standard deviation to the mean value of a series of measurements calculated using the equation: The coefficient of variation, calculated by the equation “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 parenthesis, x sub i minus x bar, close parenthesis, 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 i is the value of the i th measurement; X is the mean value of the measurements; and n is the number of measurements. ( coefficient de variation ) exposure to the X-ray image receptor means the amount of X-rays, registered by one or more detectors located in a fixed position in proximity to the X-ray image receptor, that is necessary to produce a radiogram of the overall density sought by the operator. ( exposition au récepteur d’image radiologique ) (2) For any combination of X-ray tube voltage, X-ray tube current and irradiation time, or for any selected exposure to the X-ray image receptor, when the line voltage for each measurement is accurate to within 1% of the mean line voltage value of all the measurements, and when all variable controls for the loading factors are adjusted to alternate settings and reset to the test setting before each measurement, (a) the coefficient of variation of any 10 consecutive air kerma or exposure measurements, taken at the same point along the X-ray beam axis within a period of one hour, must be no greater than 0.05; and (b) each of the 10 air kerma or exposure measurements taken under paragraph (a) must be within 15% of the mean value of those measurements. (3) For the purposes of subsection (2), diagnostic X-ray equipment with an automatic exposure control must have attenuating material in the X-ray beam that is thick enough that the loading factors can be adjusted to provide single irradiations of at least (a) 12 pulses, in the case of a field emission device that operates in pulse mode; or (b) 0.1 s, in the case of any other diagnostic X-ray equipment.
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 calculated using the equation: The coefficient of variation, calculated by the equation “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 parenthesis, x sub i minus x bar, close parenthesis, 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 i is the value of the i th measurement; X is the mean value of the measurements; and n is the number of measurements. ( coefficient de variation )