GreatNorthCollective/greatnorth-canada-federal-laws-text huggingface dataset:
Radiation Emitting Devices Regulations — Radiation Emitting Devices Regulations
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 )
Radiation Emitting Devices Regulations — 23
23 (1) This section applies in respect of diagnostic X-ray equipment that has (a) a high-voltage generator that is not a stored energy high-voltage generator; (b) loading factors that do not change automatically to compensate for unintentional variations in X-ray tube voltage; and (c) an irradiation time of at least 0.1 s and a current time product of at least 5 mAs. (2) In the case of a line voltage regulation of 6% or less, the loading factor set out in column 1 of an item of the table to this subsection must not deviate from the selected value, for any combination of loading factors, by more than the quantity set out in column 2 of that item. TABLE TO SUBSECTION 23(2) Maximum Deviation of Loading Factors Column 1 Column 2 Item Loading Factor Maximum Deviation from the Selected Value 1 X-ray tube voltage of mammography equipment 5% 2 X-ray tube voltage of non-mammography equipment 10% 3 Irradiation time 10% plus 1 ms 4 X-ray tube current 20% 5 Current time product 10% plus 0.2 mAs
Radiation Emitting Devices Regulations — 24
24 (1) The controlling timer or automatic exposure control device of diagnostic X-ray equipment must have a minimum irradiation time capability that does not exceed the greater of: (a) 1/60 s, or (b) the time required to deliver a current time product of 5 mAs. (2) If the automatic exposure control of diagnostic X-ray equipment is selected, the variation in optical density set out in subsection (3) or (4) must be determined using objects that are made of human-tissue equivalent material and have thicknesses that are representative of the actual range of the body thicknesses of the patients. (3) The automatic exposure control device of diagnostic X-ray equipment, other than mammography equipment, when the X-ray tube voltage and the thickness of the objects described in subsection (2) are held constant or varied as specified in columns 1 and 2 of an item of the table to this subsection, must limit the variation in optical density of the resulting radiograms to the quantity set out in column 3 of that item. TABLE TO SUBSECTION 24(3) Maximum Variation in Optical Density Column 1 Column 2 Column 3 Item X-ray Tube Voltage Thickness of the Object Maximum Variation in Optical Density 1 Variable Constant 0.15 2 Constant Variable 0.20 3 Variable Variable 0.20 4 Constant Constant 0.10 (4) The automatic exposure control device of mammography equipment, when both the X-ray tube voltage and the thickness of the objects described in subsection (2) are varied, must limit the variation in optical density of the resulting radiograms to 0.15.
Radiation Emitting Devices Regulations — 25
25 (1) For any selected value of X-ray tube voltage within a range determined in accordance with subsection (2), the quotients of the average air kerma or exposure measurement divided by the indicated current time product, obtained at the applicable settings specified in subsection (3), must not differ by more than 0.10 times their sum as determined by the formula |X 1 - X 2 | ≤ 0,1 (X 1 + X 2 ) where X 1 is the quotient of the average air kerma or exposure X 2 is the quotient of the average air kerma or exposure measurement divided by the current time product determined at the second of the two applicable settings specified in subsection (3). (2) The range referred to in subsection (1) is the smaller of (a) 40% to 90% of the maximum available X-ray tube voltage, or (b) the range of X-ray tube voltages specified for the diagnostic X-ray equipment by the manufacturer. (3) The quotients referred to in subsection (1) must be determined at (a) if the X-ray tube current is selected in discrete steps, any two consecutive X-ray tube current settings; (b) if the X-ray tube current selection is continuous, any two X-ray tube current settings that differ by a factor of 2 or less; (c) if the current time product is selected in discrete steps, any two consecutive current time product settings; or (d) if the current time product selection is continuous, any two current time product settings that differ by a factor of 2 or less. (4) If diagnostic X-ray equipment has more than one focal spot, the quotients referred to in subsection (1) must be determined for all combinations of two focal spots that have a nominal focal spot size greater than 0.45 mm, and all combinations of two focal spots that have a nominal focal spot size equal to or less than 0.45 mm at the applicable settings set out in subsection (3).
Radiation Emitting Devices Regulations — 26
26 (1) For mammography equipment, the residual radiation behind the image receptor supporting device must not exceed an air kerma measurement of 1.0 µGy or an exposure measurement of 0.115 mR per irradiation when the equipment is operated at (a) its maximum X-ray field and minimum focal spot to image receptor distance; and (b) its maximum X-ray tube voltage and maximum current time product. (2) For the purposes of subsection (1), the air kerma or exposure measurement must be averaged over a detection area that is 100 cm 2 , of which no linear dimension is greater than 20 cm, centred at 5 cm from any accessible surface beyond the image receptor supporting device.
Radiation Emitting Devices Regulations — 27
27 (1) Mammography equipment must have a minimum rate of radiation output of 7.0 mGy/s or 802 mR/s when the equipment is operated (a) with a molybdenum anode and molybdenum filter; (b) with the breast compression device in place between the X-ray source and the detector; and (c) at an X-ray tube voltage of 28 kV in standard mammography mode at any focal spot to image receptor distance. (2) For the purposes of subsection (1), the minimum rate of radiation output must be (a) measured at a position that is 4.5 cm above the patient support; and (b) averaged over a period of irradiation of 3.0 s.
Radiation Emitting Devices Regulations — 28
28 (1) Radioscopic equipment that has a feature described in column 1 of an item of the table to this subsection, other than when radioscopic images are being recorded, must not operate at any combination of X-ray tube voltage and X-ray tube current that results in an air kerma rate that exceeds that set out in column 2 of that item or an exposure rate that exceeds that set out in column 3 of that item: TABLE TO SUBSECTION 28(1) Maximum Air Kerma or Exposure Rate of Radioscopic Equipment, Other Than When It Is Recording Images Column 1 Column 2 Column 3 Item Feature Maximum Air Kerma Rate Maximum Exposure Rate 1 Not equipped with an automatic intensity control 50 mGy/min 5.75 R/min 2 Equipped with an automatic intensity control 100 mGy/min 11.5 R/min 3 Equipped with both an automatic intensity control and a high-level irradiation control when the latter is activated 150 mGy/min 17.25 R/min (2) For the purposes of subsection (1), the air kerma or exposure rate must be determined at a location along the X-ray beam axis that is (a) if the X-ray source is below the table, 1 cm above the table; (b) if the X-ray source is above the table, 30 cm above the table and with the X-ray source assembly positioned as closely as possible to the location of the measurement; (c) if the equipment is a C-arm radioscope, 30 cm from the input surface of the radioscopic imaging assembly; or (d) if the equipment is a lateral type radioscope, 15 cm from the centre line of the table in the direction of the X-ray source and with the X-ray source assembly positioned as closely as possible to the location of the measurement for all positions of the table.
Radiation Emitting Devices Regulations — 29
29 (1) The leakage radiation from the X-ray source assembly of diagnostic X-ray equipment must not exceed an air kerma rate of 1.0 mGy/h or an exposure rate of 115 mR/h 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. (2) For the purposes of subsection (1), the rate must be averaged over a detection area of 100 cm 2 , of which no linear dimension is greater than 20 cm, that is centred at 1 m from the focal point.
Radiation Emitting Devices Regulations — 30
30 (1) If high voltage can appear across the X-ray tube of the diagnostic X-ray equipment, then the radiation emitting from the X-ray source assembly of the equipment must not exceed an air kerma rate of 20.0 µGy/h or an exposure rate of 2.3 mR/h when (a) the equipment is operated with its beam limiting device fully open; and (b) the automatic exposure control or the irradiation switch has not been activated. (2) For the purposes of subsection (1), the rate must be averaged over a detection area of 10 cm 2 , of which no linear dimension is greater than 5 cm, that is centred at 5 cm from any accessible surface of the X-ray source assembly.
Radiation Emitting Devices Regulations — 31
31 (1) Under any operating condition, the radiation from any component of diagnostic X-ray equipment, other than the X-ray source assembly, must not exceed an air kerma rate of 20.0 µGy/h or an exposure rate of 2.3 mR/h. (2) For the purposes of subsection 1, the rate must be averaged over a detection area of 10 cm 2 , of which no linear dimension is greater than 5 cm, that is centred at 5 cm from any accessible surface of the component.
Radiation Emitting Devices Regulations — 32
32 (1) In the case of radioscopic equipment, the radiation resulting from the transmission of the X-ray beam through, or scattered from, the entrance window of the radioscopic imaging assembly must not exceed an air kerma rate of 2 mGy/h for an entrance air kerma rate of 1 Gy/min or an exposure rate of 2 mR/h for an entrance exposure rate of 1 R/min. (2) For the purposes of subsection (1), the rate must be (a) taken at the applicable location specified in subsection 28(2) for the type or configuration of the equipment; (b) taken with an attenuation block made of aluminum and having the dimensions 20 cm by 20 cm by 3.8 cm that is positioned between the point of entrance of the radiation and the image reception area of the radioscopic imaging assembly; and (c) averaged over a detection area of 100 cm 2 that is centred 10 cm from any accessible surface of the radioscopic imaging assembly and in a plane beyond the image receptor.
Radiation Emitting Devices Regulations — 1
 returns to that value; ( durée des impulsions ) pulse repetition rate means the repetition frequency of the wave shape that modulates the ultrasonic radiation carrier wave expressed in pulses per second (pps); ( taux de répétition des impulsions ) service controls means controls provided by the manufacturer for adjusting the ultrasound therapy device that, under normal conditions of use, are not accessible to the user; ( commandes internes ) transducer [Revoked, SOR/84-930, s. 2] ultrasonic frequency means the frequency of the ultrasonic power wave, expressed in kilohertz (kHz) or megahertz (mHz); ( fréquence ) ultrasonic power means the total power that is emitted in the form of ultrasonic radiation by the applicator and that is averaged over each cycle of the ultrasonic radiation carrier wave, expressed in watts (W); ( puissance acoustique ) user controls means controls provided by the manufacturer for operating the ultrasound therapy device that, under normal conditions of use, are accessible to the user. ( commandes externes )
Radiation Emitting Devices Regulations — Radiation Emitting Devices Regulations
amplitude modulated wave means a wave in which the ratio of the temporal maximum pressure amplitude to the root-mean square pressure amplitude, each spatially averaged over the effective radiating surface, is greater than 1.05; ( onde modulée en amplitude )
Radiation Emitting Devices Regulations — Radiation Emitting Devices Regulations
applicator means the part of the ultrasound therapy device designed to transmit ultrasonic power from the transducer to a patient and includes the transducer and any associated housing; ( applicateur )
Radiation Emitting Devices Regulations — Radiation Emitting Devices Regulations
continuous wave means a wave in which the ratio of the temporal maximum pressure amplitude to the root-mean square pressure amplitude, each spatially averaged over the effective radiating surface, is less than or equal to 1.05; ( onde entretenue )
Radiation Emitting Devices Regulations — Radiation Emitting Devices Regulations
control panel means that portion of the external surface of the housing on which the user controls are mounted; ( tableau de commande )
Radiation Emitting Devices Regulations — Radiation Emitting Devices Regulations
effective intensity [Revoked, SOR/84-930, s. 2]
Radiation Emitting Devices Regulations — Radiation Emitting Devices Regulations
effective radiating area means the area of the effective radiating surface that encompasses all points at which the ultrasonic intensity is equal to or greater than five per cent of the maximum spatial ultrasonic intensity at the effective radiating surface, expressed in square centimetres (cm 2 ); ( aire émettrice utile )
Radiation Emitting Devices Regulations — Radiation Emitting Devices Regulations
effective radiating surface means the surface covering all points that are 5 mm from the applicator face; ( surface émettrice utile )
Radiation Emitting Devices Regulations — (a)
effective ultrasonic intensity , with respect to ultrasonic power, means (a) in the case of a focussing applicator, the quotient obtained by dividing the amount of the ultrasonic power by the amount of the focal area, and (b) in any other case, the quotient obtained by dividing the amount of the ultrasonic power by the amount of the effective radiating area; ( intensité ultrasonore utile )
Radiation Emitting Devices Regulations — Radiation Emitting Devices Regulations
focal area means the area of the focal surface expressed in square centimetres (cm 2 ); ( aire focale )
Radiation Emitting Devices Regulations — (a)
focal length in respect of a focussing applicator, means the distance in centimetres between (a) that point of the effective radiating surface the coordinates of which are the mean values of the coordinates of the points of that surface, and (b) that point of the focal surface the coordinates of which are the mean values of the coordinates of the points of that surface; ( longueur focale )
Radiation Emitting Devices Regulations — Radiation Emitting Devices Regulations
focal surface in respect of a focussing applicator, means the beam cross-section with the smallest area; ( surface focale )
Radiation Emitting Devices Regulations — Radiation Emitting Devices Regulations
focussing applicator means an applicator in which the quotient of the area of the surface having the smallest area, in any plane consisting of the points at which the ultrasonic intensity is greater than five per cent of the maximum intensity in that plane, and the effective radiating area is less than one-half; ( applicateur focalisant )
Radiation Emitting Devices Regulations — (a)
housing means a structure that encloses (a) that portion of a fully assembled ultrasound therapy device that supplies the electrical energy to the applicator, and (b) the electrical circuitry of the device; ( logement )
Radiation Emitting Devices Regulations — Radiation Emitting Devices Regulations
maximum intensity [Revoked, SOR/84-930, s. 2]
Radiation Emitting Devices Regulations — Radiation Emitting Devices Regulations
pressure amplitude means the instantaneous value of the modulating waveform in the following equation: p(t)=p 1 (t)p 2 (t) where p(t) is the instantaneous pressure, p 1 (t) is the modulating wave form, p 2 (t) is the relative amplitude of the carrier wave normalized to a peak height of one, p(t), p 1 (t) and p 2 (t) are periodic functions of time, t, at any point in space, and the period of p 1 (t) is greater than the period p 2 (t); ( amplitude de pression )
Radiation Emitting Devices Regulations — Radiation Emitting Devices Regulations
pulse duration means a time interval, expressed in seconds, beginning at the first time the pressure amplitude exceeds the value that equals the sum of the minimum pressure amplitude and 10 per cent of the difference between the maximum and minimum pressure amplitudes and ending at the last time the pressure amplitude returns to that value; ( durée des impulsions )
Radiation Emitting Devices Regulations — Radiation Emitting Devices Regulations
pulse repetition rate means the repetition frequency of the wave shape that modulates the ultrasonic radiation carrier wave expressed in pulses per second (pps); ( taux de répétition des impulsions )
Radiation Emitting Devices Regulations — Radiation Emitting Devices Regulations
service controls means controls provided by the manufacturer for adjusting the ultrasound therapy device that, under normal conditions of use, are not accessible to the user; ( commandes internes )
Radiation Emitting Devices Regulations — Radiation Emitting Devices Regulations
ultrasonic frequency means the frequency of the ultrasonic power wave, expressed in kilohertz (kHz) or megahertz (mHz); ( fréquence )
Radiation Emitting Devices Regulations — Radiation Emitting Devices Regulations
ultrasonic power means the total power that is emitted in the form of ultrasonic radiation by the applicator and that is averaged over each cycle of the ultrasonic radiation carrier wave, expressed in watts (W); ( puissance acoustique )
Radiation Emitting Devices Regulations — Radiation Emitting Devices Regulations
user controls means controls provided by the manufacturer for operating the ultrasound therapy device that, under normal conditions of use, are accessible to the user. ( commandes externes )
Radiation Emitting Devices Regulations — 3
3 (1) Every ultrasound therapy device shall function in such a manner that when the device is operating with its user controls adjusted to yield the maximum temporal average-spatial average effective ultrasonic intensity, such intensity shall not exceed 3 W/cm 2 , when measured in accordance with subsection (2). (2) The method used to measure the effective ultrasonic intensity for the purposes of subsection (1) shall produce a result that is at least as accurate as the result that would be produced by using (a) an ultrasound balance radiometer to measure the ultrasonic power; and (b) an ultrasound detector of dimensions less than one wavelength in water to measure the pulse repetition rate, the pulse duration and the effective radiating area. (3) The power indicator referred to in paragraph 2(4)(b) shall show on the scale of the ultrasonic power control or on the output power meter the ultrasonic power with an accuracy of ±20 per cent when the output is greater than 10 per cent of the maximum ultrasonic power. (4) The timer referred to in paragraph 2(4)(d) shall be accurate to within 30 seconds for settings less than five minutes, to within 10 per cent for settings from five to 10 minutes, and to within one minute for settings greater than 10 minutes. (5) The ultrasonic power output shall remain constant within ±20 per cent of its initial value during one hour of continuous operation, at maximum output and at rated supply line voltage, in water at a temperature of 22°C ± 3°C. (6) The actual ultrasonic frequency of an ultrasound therapy device shall not differ more than ±5% from the ultrasonic frequency of the device that is stated on the external surface of the housing of the device pursuant to subparagraph 2(3)(a)(vi). (7) The effective radiating area shall be kept within ±20 per cent of the rated value given by the manufacturer.
Radiation Emitting Devices Regulations — 4
4 The warning sign referred to in subparagraph 2(3)(a)(x) is a sign that (a) is shown in two contrasting colours; (b) is clearly visible and identifiable from a distance of 1 m; (c) has no outer dimensions less than 2 cm; (d) bears the words “CAUTION-ULTRASOUND, ATTENTION-ULTRASONS ”; and (e) is designed in accordance with the following diagram: Warning sign, bearing the words “CAUTION-ULTRASOUND, ATTENTION-ULTRASONS”, described by an inverted triangle containing a small rectangle with a curled line attached in the right corner emitting a series of lines
Radiation Emitting Devices Regulations — 1
1 The definitions in this section apply in this Part. accessory means any component used on analytical X-ray equipment in order to enable the equipment to perform its intended use, to adapt the equipment to some special purpose, to facilitate use of the equipment, to enhance the performance of the equipment or to enable the function of the equipment to be integrated with that of other equipment. ( accessoire ) beam-limiting device means a device that limits the dimensions of a radiation beam. ( dispositif de limitation du faisceau ) control panel means that part of analytical X-ray equipment on which are mounted (a) one or more manually-operated controls that regulate all, or some, of the functions of the equipment; and (b) meters, lights or other indicators that disclose operating factors and conditions. ( poste de commande ) high-voltage generator means a combination of the components necessary for the production and control of the electrical energy to be supplied to an X-ray tube, which components usually consist of a high-voltage transformer assembly and a control assembly. ( générateur radiologique ) interlock means a system that prevents the start or the continued operation of equipment unless certain predetermined conditions prevail. ( verrouillage ) protective shielding means material that limits the extent of a radiation beam or attenuates stray radiation. ( barrière de protection radiologique ) radiation aperture means an aperture in the protective shielding of a radiation source or a beam-limiting device, that is intended to give passage to the radiation beam. ( fenêtre ) radiation beam means a spatial region that is limited in solid angle and that contains a flux of ionizing radiation which originates from a radiation source that is considered a point source. ( faisceau de rayonnement ) shutter means a mechanism that opens or closes a radiation aperture to enable or prevent the passage of a radiation beam. ( obturateur ) stray radiation means all ionizing radiation except that of the specified radiation beam under consideration, but includes that part of the radiation beam which emerges from the material being irradiated. ( rayonnement parasite ) timing device means a device that (a) integrates or presents the time elapsed during an equipment function; and (b) changes the state of operation at the end of a predetermined time interval. ( intégrateur de temps )
Radiation Emitting Devices Regulations — Radiation Emitting Devices Regulations
accessory means any component used on analytical X-ray equipment in order to enable the equipment to perform its intended use, to adapt the equipment to some special purpose, to facilitate use of the equipment, to enhance the performance of the equipment or to enable the function of the equipment to be integrated with that of other equipment. ( accessoire )
Radiation Emitting Devices Regulations — Radiation Emitting Devices Regulations
beam-limiting device means a device that limits the dimensions of a radiation beam. ( dispositif de limitation du faisceau )
Radiation Emitting Devices Regulations — (a)
control panel means that part of analytical X-ray equipment on which are mounted (a) one or more manually-operated controls that regulate all, or some, of the functions of the equipment; and (b) meters, lights or other indicators that disclose operating factors and conditions. ( poste de commande )
Radiation Emitting Devices Regulations — Radiation Emitting Devices Regulations
high-voltage generator means a combination of the components necessary for the production and control of the electrical energy to be supplied to an X-ray tube, which components usually consist of a high-voltage transformer assembly and a control assembly. ( générateur radiologique )