Mississippi Administrative Code
Title 15 - Mississippi Department of Health
Part 21 - Division of Radiological Health
Subpart 78 - Radiological Health
Chapter 1 - REGULATIONS FOR CONTROL OF RADIATION IN MISSISSIPPI
Subchapter 6 - X-Rays In The Healing Arts
Rule 15-21-78-1.6.5 - Fluoroscopic X-Ray Systems
Universal Citation: MS Code of Rules 15-21-78-1.6.5
Current through September 24, 2024
All fluoroscopic x-ray systems shall be image intensified and meet the following requirements:
1. Limitation of Useful Beam.
a
Primary Barrier.
i. The fluoroscopic imaging assembly used
shall be provided with a primary protective barrier which intercepts the entire
cross section of the useful beam at any SID.
ii. The x-ray tube used for fluoroscopy shall
not produce x-rays unless the barrier is in position to intercept the entire
useful beam.
b
Fluoroscopic Beam Limitation.
i.
For certified fluoroscopic systems, neither the length nor the width of the
x-ray field in the plane of the image receptor shall exceed that of the visible
area of the image receptor by more than 3 percent of the SID. The sum of the
excess length and the excess width shall be no greater than 4 percent of the
SID.
ii. For uncertified
fluoroscopic systems with a spot film device, the x-ray beam with the shutters
fully opened (during fluoroscopy or spot filming) shall be no larger than the
largest spot film size for which the device is designed. Measurements shall be
made at the minimum SID available but at no less than 20 centimeters table top
to the film plane distance.
iii.
For uncertified fluoroscopic systems without a spot film device, the
requirements of 1.6.5(1)(b)(i) apply.
iv. Other requirements for fluoroscopic beam
limitation:
i. Means shall be provided to
permit further limitation of the field. Beam-limiting devices manufactured
after May 22, 1979, and incorporated in equipment with a variable SID and/or a
visible area of greater than 300 square centimeters shall be provided with
means for stepless adjustments of the x-ray field.
ii. All equipment with a fixed SID and a
visible area of 300 square centimeters or less shall be provided with either
stepless adjustment of the x-ray field or with means to further limit the x-ray
field size at the plane of the image receptor to 125 square centimeters or
less.
iii. If provided, stepless
adjustment shall provide continuous field sizes from the maximum obtainable to
a field size of 5 centimeters by 5 centimeters or less.
iv. For equipment manufactured after February
25, 1978, when the angle between the image receptor and beam axis is variable,
means shall be provided to indicate when the axis of the x-ray beam is
perpendicular to the plane of the image receptor; compliance shall be
determined with the beam axis indicated to be perpendicular to the plane of the
image receptor.
v. For rectangular
x-ray fields used with circular image reception, the error in alignment shall
be determined along the length and width dimensions of the x-ray field which
pass through the center of the visible area of the image receptor.
c. Spot Film
Beam Limitation. Spot-film devices which are certified components shall meet
the following additional requirements:
i.
Means shall be provided between the source and the patient for adjustment of
the x-ray field size in the plane of the film to the size of that portion of
the film which has been selected on the spot film selector. Such adjustment
shall be automatically accomplished except when the x-ray field size in the
plane of the film is smaller than that of the selected portion of the film. For
spot film devices manufactured after June 21, 1979, if the x-ray field size is
less than the size of the selected portion of the film, the means for
adjustment of the field size shall be only at the operator's option.
d. It shall be possible to adjust
the x-ray field size in the plane of the film to a size smaller than the
selected portion of the film. The minimum field size at the greatest SID shall
be equal to, or less than, 5 centimeters by 5 centimeters.
e. The center of the x-ray field in the plane
of the film shall be aligned with the center of the selected portion of the
film to within 2 percent of the SID.
f. On spot-film devices manufactured after
February 25, 1978, if the angle between the plane of the image receptor and
beam axis is variable, means shall be provided to indicate when the axis of the
x-ray beam is perpendicular to the plane of the image receptor, and compliance
shall be determined with the beam axis indicated to be perpendicular to the
plane of the image receptor.
g.
Override. If a means exists to override any of the automatic x-ray field size
adjustments required in 1.6.5(1)(b), and (c) that means:
i. shall be designed for use only in the
event of system failure;
ii. shall
incorporate a signal visible at the fluoroscopist's position which will
indicate whenever the automatic field size adjustment is overridden;
and
iii. shall be clearly and
durably labeled as follows:
FOR X-RAY FIELD
LIMITATION SYSTEM FAILURE
2. Activation of the Fluoroscopic Tube. X-ray production in the fluoroscopic mode shall be controlled by a device which requires continuous pressure by the fluoroscopist for the entire time of any exposure. When recording serial fluoroscopic images, the fluoroscopist shall be able to terminate the x-ray exposure(s) at any time, but means may be provided to permit completion of any single exposure of the series in process.
3 Exposure Rate Limits.
a
Entrance Exposure Rate
Allowable Limits.
i. Fluoroscopic
equipment which is provided with automatic exposure rate control shall not be
operable at any combination of tube potential and current which will result in
an exposure rate in excess of 10 roentgens (2.58 mC/kg) per minute at the point
where the center of the useful beam enters the patient, except:
i. During recording of fluoroscopic images,
or
ii. When an optional high level
control is provided. When so provided, the equipment shall not be operable at
any combination of tube potential and current which will result in an exposure
rate in excess of 5 roentgens (1.29 mC/kg) per minute at the point where the
center of the useful beam enters the patient unless the high level control is
activated. Special means of activation of high level controls shall be
required. The high level control shall only be operable when continuous manual
activation is provided by the operator. A continuous signal audible to the
fluoroscopist shall indicate that the high level control is being
employed.
ii. Fluoroscopic
equipment which is not provided with automatic exposure rate control shall not
be operable at any combination of tube potential and current which will result
in an exposure rate in excess of 5 roentgens (1.29 mC/kg) per minute at the
point where the center of the useful beam enters the patient, except:
i. During recording of fluoroscopic images,
or
ii. When an optional high level
control is activated. Special means of activation of high level controls shall
be required. The high level control shall only be operable when continuous
manual activation is provided by the operator. A continuous signal audible to
the fluoroscopist shall indicate that the high level control is being
employed.
iii.
Compliance with the requirements of 1.6.5(3) shall be determined as follows:
i. If the source is below the x-ray table,
the exposure rate shall be measured 1 centimeter above the tabletop or
cradle.
ii. If the source is above
the x-ray table, the exposure rate shall be measured at 30 centimeters above
the tabletop with the end of the beam-limiting device or spacer positioned as
closely as possible to the point of measurement.
iii. For a C-arm type of fluoroscope, the
exposure rate shall be measured 30 centimeters from the input surface of the
fluoroscopic imaging assembly, with the source positioned at any available SID,
provided that the end of the beam-limiting device or spacer is no closer than
30 centimeters from the input surface of the fluoroscopic imaging
assembly.
iv. For a lateral type
fluoroscope, the exposure rate shall be measured at a point 15 centimeters from
the center line of the x-ray table and in the direction of the x-ray source
with the end of the beam-limiting device or spacer positioned as closely as
possible to the point of measurement. If the tabletop is movable, it shall be
positioned as closely as possible to the lateral x-ray source, with the end of
the beam limiting device or spacer no closer than 15 centimeters to the center
line of the x-ray table.
b. Periodic measurement of entrance exposure
rate shall be performed by a qualified expert for both maximum and typical
values, as follows. 30
i. Such measurements
shall be made annually or after any maintenance of the system which might
affect the exposure rate.
ii.
Results of these measurements shall be posted where any fluoroscopist may have
ready access to such results while using the fluoroscope and in the record
required in 1.6.3(1)(l)(iii) The measurement results shall be stated in
roentgens per minute and include the technique factors used in determining such
results. The name of the person performing the measurements and the date the
measurements were performed shall be included in the results.
iii. Conditions of periodic measurement of
maximum entrance exposure rate are as follows:
i. the measurement shall be made under the
conditions that satisfy the requirements of 1.6.5(3)(a)(iii);
ii. the kVp, mA, and/or other selectable
parameters shall be adjusted to those settings which give the maximum entrance
exposure rate; and
iii. the x-ray
system that incorporates automatic exposure rate control shall have sufficient
attenuative material placed in the useful beam to produce the maximum output of
that system.
iv.
Conditions of periodic measurement of typical entrance exposure rate are as
follows:
i. the measurement shall be made
under the conditions that satisfy the requirements of
1.6.5(3)(a)(iii);
ii. the kVp and
mA shall be typical of clinical use of the x-ray system; and
iii. the x-ray system(s) that incorporates
automatic exposure rate control shall have an appropriate phantom placed in the
useful beam to produce a milliamperage and/or kilovoltage typical of the use of
the x-ray system.
4 Barrier Transmitted Radiation Rate Limits.
a. The exposure rate due to
transmission through the primary protective barrier with the attenuation block
in the useful beam, combined with radiation from the image intensifier shall
not exceed 2 milliroentgens (0.516 µC/kg) per hour at 10 centimeters 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.
b
Measuring Compliance of
Barrier Transmission.
i. The exposure
rate due to transmission through the primary protective barrier combined with
radiation from the image intensifier shall be determined by measurements
averaged over an area of 100 square centimeters with no linear dimension
greater than 20 centimeters.
ii. If
the source is below the tabletop, the measurement shall be made with the input
surface of the fluoroscopic imaging assembly positioned 30 centimeters above
the tabletop.
iii. If the source is
above the tabletop and the SID is variable, the measurement shall be made with
the end of the beam-limiting device or spacer as close to the tabletop as it
can be placed, provided that it shall not be closer than 30
centimeters.
iv. Compression
devices and movable grids shall be removed from the useful beam during the
measurement.
5 Indication of Potential and Current. During fluoroscopy and cinefluorography, the kV and the mA shall be continuously indicated.
6. Source-to-Skin Distance. The SSD shall not be less than:
a. 38 centimeters on stationary
fluoroscopic systems manufactured on or after August 1, 1974;
b. 35.5 centimeters on stationary
fluoroscopic systems manufactured prior to August 1, 1974;
c. 30 centimeters on all mobile fluoroscopes;
and
d. 20 centimeters for all
mobile fluoroscopes used for specific surgical procedures.
7 Fluoroscopic Timer.
a. Means shall be provided to preset the
cumulative on-time of the fluoroscopic x-ray tube. The maximum cumulative time
of the timing device shall not exceed 5 minutes without resetting.
b. A signal audible to the fluoroscopist
shall indicate the completion of any preset cumulative on-time. Such signal
shall continue to sound while x-rays are produced until the timing device is
reset.
8 Control of Scattered Radiation.
a.
Fluoroscopic table designs when combined with procedures utilized shall be such
that no unprotected part of any staff or ancillary individual's body shall be
exposed to unattenuated scattered radiation which originates from under the
table. The attenuation required shall be not less than 0.25 millimeter lead
equivalent.
b. Equipment
configuration when combined with procedures shall be such that no portion of
any staff or ancillary individual's body, except the extremities, shall be
exposed to the unattenuated scattered radiation emanating from above the table
top unless that individual:
i. is at least
120 centimeters from the center of the useful beam; or
ii. the radiation has passed through not less
than 0.25 millimeter lead equivalent material including, but not limited to,
drapes, Bucky-slot cover panel, or self-supporting curtains, in addition to any
lead equivalency provided by the protective apron referred to in
1.6.3(1)(h)(vii).
c. The
Agency may grant exemptions to 1.6.5(8)(b) where a sterile field will not
permit the use of the normal protective barriers. Where the use of prefitted
sterilized covers for the barriers is practical, the Agency shall not permit
such exemption. See Appendix C for a suggested list of fluoroscopic procedures
where such exemptions will be automatically granted.
9. Spot Film Exposure Reproducibility. Fluoroscopic systems equipped with spot film (radiographic) mode shall meet the exposure reproducibility requirements of 1.6.6(4) when operating in the spot film mode.
10. Radiation Therapy Simulation Systems. Radiation therapy simulation systems shall be exempt from all the requirements of 1.6.5(1), 1.6.5(3), 1.6.5(4), and 1.6.5(7) provided that:
a. such systems are designed and used
in such a manner 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
b. systems which do not meet the requirements
of 1.6.5(7) 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.
30 Materials should be placed in the useful beam to protect the imaging system when conducting these periodic measurements.
Miss. Code Ann. § 45-14-11
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