New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter I - State Sanitary Code › Part 16 - Ionizing Radiation › Radiation Equipment › Section 16.58 - Fluoroscopic installations excluding veterinary installations

Current through Register Vol. 46, No. 28, July 10, 2024
(a)
Equipment.
(1) The protective
				  tube housing shall be of the diagnostic type.
(2) Equipment shall be constructed so that
				  the entire cross section of the useful beam is always intercepted by the
				  primary protective barrier respective of the position.
(i) Collimators and adjustable diaphragms or
				  shutters used to restrict the size of the useful beam shall provide the same
				  degree of protection as is required of the tube housing.
(ii) The exposure shall automatically
				  terminate when the barrier is removed from the useful beam.
(3) The aluminum equivalent of the
				  total filtration in the useful beam shall not be less than that shown below:
(i) for equipment manufactured prior to
				  August 1, 1974:
Operating kVp
Minimum total filtration (Inherent plus
								added)
Below 50 kVp
0.5 mm aluminum
50-70 kVp
1.5 mm aluminum
Above 70 kVp
2.5 mm aluminum
(ii) for equipment manufactured after August
				  1, 1974:
Designed operating range
								(kVp)
Measured operating
								  potential (kVp)
Minimum HVL mm of
								  Al
Below 51
30
0.3
40
0.4
50
0.5
51 to 70
51
1.2
60
1.3
70
1.5
Above 70
71
2.1
80
2.3
90
2.5
100
2.7
110
3.0
120
3.2
130
3.5
140
3.8
150
4.1
(4) Fluoroscopic exposure switch shall be of
				  the dead-man type.
(5) The source
				  tabletop distance shall not be less than 12 inches (30 cm) and should not be
				  less than 15 inches (38 cm).
(6)
				  Fluoroscopy equipment shall not be operated for human use unless a cumulative
				  timing device, activated by the fluoroscope exposure switch, is functioning. It
				  shall indicate the passage of a period of irradiation, not exceeding five
				  minutes, either by a signal audible to the operator or by temporary
				  interruption of the irradiation.
(7)
(i) The
				  fluoroscopic exposure rate when measured under the following conditions shall
				  not exceed five Roentgens per minute:
(a) the
				  controls are set to the dose rate mode used for the fluoroscopic procedure most
				  commonly performed on that fluoroscopic unit;
(b) the image intensifier is set to the
				  largest field of view;
(c) the
				  image intensifier is at 12 inches (30 cm) above the tabletop or the overtable
				  fluro tube is at a source to image distance normally used for an average
				  patient;
(d) a patient phantom
				  composed of 11/2 inches (3.8 cm) thickness of type 1100 aluminum and 0.02 inch
				  (0.5 mm) thickness of copper or an equivalent device is completely intercepting
				  the useful beam; and
(e) the
				  measurement is made at the measurement location specified in
				  21 CFR section
				  1020.32(d)(3) (see section
				  16.200  of this Part).
(ii) If the exposure rate cannot
				  be measured, the exposure integrated for one minute under the same conditions
				  as subparagraph (i) of this paragraph shall not exceed five
				  Roentgens.
(8) Using the
				  measurement locations specified in
				  21 CFR section
				  1020.32(d)(3) (see section
				  16.200  of this Part), the maximum
				  exposure rate measured in air shall not exceed 10 Roentgens per minute except
				  as follows:
(i) Equipment manufactured before
				  May 19, 1995 and certified in accordance with  21 CFR part 1020  (see section
				  16.200  of this Part) and having an
				  optional high level control is limited to a maximum output of five Roentgens
				  per minute unless the high level control is activated and an audible signal to
				  that effect is provided. When the high level control is activated, the maximum
				  exposure rate measured in air at a point where the center of the useful beam
				  enters the patient shall not exceed 20 Roentgens per minute.
(ii) Certified equipment manufactured after
				  May 19, 1995 with automatic exposure rate and having an optional high level
				  control is limited to a maximum output of 10 Roentgens per minute unless the
				  high level control is activated and an audible signal to that effect is
				  provided. When the high level control is activated, the maximum exposure rate
				  measured in air at a point where the center of the useful beam enters the
				  patient shall not exceed 20 Roentgens per minute.
(iii) Certified equipment manufactured after
				  May 19, 1995 without automatic exposure rate is limited to five Roentgens per
				  minute unless the high level control is activated and an audible signal to that
				  effect is provided. When the high level control is activated, the maximum
				  exposure rate measured in air at a point where the center of the useful beam
				  enters the patient shall not exceed 20 Roentgens per minute.
(9) With the system configured for
				  the most frequently performed procedure, the fluoroscopic and fluorographic, if
				  the system is equipped for image acquisition, exposure rates shall be measured
				  with each of the following attenuators in the beam:
0.75 inch (19 mm) of aluminum (pediatric patient - 25 kg.);
					 .......
1.50 inches (38 mm) of aluminum (small adult patient - 50
					 kg.; .......
1.50 inches (38 mm) of aluminum and 0.02 inch (0.5 mm) of
					 copper (average adult patient -75 kg.); .......
1.50 inches (38 mm) of aluminum and 0.08 inch (2.0 mm) of
					 copper (large adult patient - 100 kg); .......
1.50 inches (38 mm) of aluminum and 0.08 inch (2.0 mm) of
					 copper and 0.12 inch (3.0 mm) of lead (for maximum fluoroscopic exposure rate
					 only). .......
The fluoroscopic exposure rates for the most frequently
					 performed procedure shall be posted so that they are conspicuous to the
					 operator.
(10) Primary
				  protective barriers shall provide the following protection:
(i) for uncertified equipment, with the image
				  intensifier 14 inches (36 cm) from the tabletop, the exposure rate two inches
				  (5 cm) beyond the image intensifier shall not exceed 30 mR/hr for each Roentgen
				  per minute at the tabletop with the intensifier in the useful beam without a
				  patient and with the fluoroscope operating at the highest potential available
				  for use.
(ii) for certified
				  equipment, the exposure rate due to transmission through the barrier with the
				  attenuation block in the useful beam combined with radiation from the image
				  intensifier, if provided, shall not exceed two milliroentgens per hour at four
				  inches (10 cm) from any accessible surface of the fluoroscopic imaging assembly
				  beyond the plane of the image receptor for each Roentgen per minute of entrance
				  exposure rate.
(11) In
				  the absence of a tabletop, a cone or spacer frame shall limit the
				  source-to-skin distance to not less than 12 inches (30 cm) for all mobile
				  fluoroscopic equipment. Units intended for specific surgical application may be
				  used at shorter source skin distances but in no case less than eight inches (20
				  cm).
(12) The spatial resolution of
				  the fluoroscopic system shall be measured using a test tool composed of a line
				  pair (lp) plate with discreet line pair groups and a maximum lead foil
				  thickness of 0.1 mm or an equivalent device. The test tool shall be placed on a
				  0.75 inch (19 mm) thickness of type 1100 aluminum, large enough to completely
				  intercept the useful beam, with the test tool 12 inches (30 cm) from the
				  entrance surface of the image receptor assembly. If the system has variable
				  source-to-image distance (SID), the measurement SID shall not exceed 40 inches
				  (100 cm). The image receptor of the fluoroscopic system shall be operated in
				  the largest available field of view (FOV) that does not exceed six inches (15
				  cm). If all the fluoroscopic system's FOVs exceed six inches (15 cm), the
				  system shall be operated in the smallest FOV. The minimum spatial resolution at
				  center of the beam for all FOVs shall be determined by the following equation:
				  2 lp/mm × (6 inches [15cm]/size of FOV used) = minimum number of
				  lp/mm.
(13) The low contrast
				  performance of the fluoroscopic system shall be capable of resolving a minimum
				  hole size of 3 mm using a test tool composed of a 1.0 mm aluminum sheet with
				  two sets of four holes of dimension 1.0, 3.0, 5.0 and 7.0 mm and a phantom
				  composed of a 11/2 inch (3.8 cm) thickness of type 1100 aluminum large enough
				  to completely intercept the useful beam or an equivalent device. The test tool
				  shall be 12 inches (30 cm) from the entrance surface of the image receptor
				  assembly. The image receptor of the fluoroscopic system shall be operated in
				  the largest available field of view (FOV) that does not exceed six inches (15
				  cm). If all the fluoroscopic system's FOVs exceed six inches (15 cm), the
				  system shall be operated in the smallest FOV.
(14) Radiation therapy simulation systems
				  shall be exempt from the requirements of paragraphs (2), (6), (7) and (8) of
				  this subdivision provided that:
(i) the
				  systems are designed and used in a manner such that no individual other than
				  the patient is in the X-ray room during periods of time when the system is
				  producing X-rays; and
(ii) systems
				  which do not meet the requirements of paragraph (6) of this subdivision are
				  provided with a means of indicating the cumulative time that an individual
				  patient has been exposed to X-rays. Procedures shall require in such cases that
				  the timer be reset between examinations.