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
Universal Citation: 10 NY Comp Codes Rules and Regs ยง 16.58
Current through Register Vol. 46, No. 39, September 25, 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.
(b) Conditions for operation of equipment.
(1) The operator of the
installation shall make and record the exposure and exposure rate measurements
made pursuant to paragraphs (a)(7) and (8) of this section, where the center of
the useful beam enters the patient during routine fluoroscopy and
cinefluoroscopy, at annual intervals or more frequently if outputs are found to
exceed the limits defined in this section.
(2) Unless measurements indicate that they
are not needed protective garments of at least 0.25 mm lead equivalent each
shall be worn by all persons within the fluoroscopic room except for the
patient.
(3) Only persons needed in
the fluoroscopic room shall be present during irradiation.
(4) The cumulative fluoroscopic timer must be
reset for each new patient.
Disclaimer: These regulations may not be the most recent version. New York may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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