Statutes, codes, and regulations
Rhode Island Administrative Code
Title 216 - Department of healthChapter 40 - Professional licensing and facility regulationSubchapter 20 - Radiation
Part 4 - Medical Diagnostic and Interventional X-Ray and Imaging Systems
Section 216-RICR-40-20-4.4 - General Requirements for All Diagnostic and Interventional X-ray Systems

216 R.I. Code R. 216-RICR-40-20-4.4

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Current through October 15, 2024
Section 216-RICR-40-20-4.4 - General Requirements for All Diagnostic and Interventional X-ray Systems
4.4.1Applicability

In addition to other requirements of this Part, all diagnostic and interventional X-ray systems shall meet the requirements of § 4.4 of this Part. Requirements specific to dental intra-oral, panoramic, cephalometric, volumetric dental imaging equipment are included in § 4.14 of this Part.

4.4.2Maintaining Compliance

Diagnostic and interventional X-ray systems and their associated components used on humans and certified pursuant to the Federal X-ray Equipment Performance Standard ( 21 C.F.R. Part 1020) shall be maintained in compliance with applicable requirements of that standard.

4.4.3Warning Label
A. On systems manufactured on or before June 10, 2006, the control panel containing the main power switch shall bear the following warning statement, or the warning statement in §4.4.3(B) of this Part, legible and accessible to view: "WARNING: This X-ray unit may be dangerous to patient and operator unless safe exposure factors and operating instructions are observed."
B. On systems manufactured after June 10, 2006, the control panel containing the main power switch shall bear the following warning statement, legible and accessible to view: "WARNING: This X-ray unit may be dangerous to patient and operator unless safe exposure factors, operating instructions and maintenance schedules are observed."
4.4.4Battery Charge Indicator

On battery-powered X-ray generators, visual means shall be provided on the control panel to indicate whether the battery is in a state of charge adequate for proper operation.

4.4.5Leakage Radiation from the Diagnostic Source Assembly

The leakage radiation from the diagnostic source assembly measured at a distance of one meter (1 m) in any direction from the source shall not exceed eighty-eight one hundredths milligray (0.88 mGy) air kerma [one hundred milliroentgen (100 mR) exposure] in one (1) hour when the X-ray tube is operated at its leakage technique factors. If the maximum rated peak tube potential of the tube housing assembly is greater than the maximum rated peak tube potential for the diagnostic source assembly, positive means shall be provided to limit the maximum X-ray tube potential to that of the diagnostic source assembly. Compliance shall be determined by measurements averaged over an area of one hundred square centimeters (100 cm2) with no linear dimension greater than twenty centimeters (20 cm).

4.4.6Radiation from Components Other Than the Diagnostic Source Assembly

The radiation emitted by a component other than the diagnostic source assembly shall not exceed an air kerma of eighteen (18) µgray [two (2) milliroentgens exposure] in one (1) hour at five centimeters (5 cm) from any accessible surface of the component when it is operated in an assembled X-ray system under any conditions for which it was designed. Compliance shall be determined by measurements averaged over an area of one hundred square centimeters (100 cm2) with no linear dimension greater than twenty centimeters (20 cm).

4.4.7Beam Quality
A. Half-Value Layer (HVL)
1. The HVL of the useful beam for a given X-ray tube potential shall not be less than the values shown in §4.4.7(B) of this Part [Table 1], If it is necessary to determine such half-value layer at an X-ray tube potential which is not listed in §4.4.7(B) of this Part [Table 1], linear interpolation or extrapolation may be made. Positive means shall be provided to ensure that at least the minimum filtration needed to achieve beam quality requirements is in the useful beam during each exposure. In the case of a system, which is to be operated with more than one (1) thickness of filtration, this requirement can be met by a filter interlocked with the kilovoltage selector which will prevent X-ray emissions if the minimum required filtration is not in place.
2. Optional Filtration on Fluoroscopic Systems. Fluoroscopic systems manufactured on or after June 10, 2006, incorporating an X-ray tube(s) with a continuous output of one (1) kilowatt or more and an anode heat storage capacity of one million (1,000,000) heat units or more shall provide the option of adding X-ray filtration to the diagnostic source assembly in addition to the amount needed to meet the half-value layer provisions of §4.4.7(A)(1) of this Part. The selection of this additional X-ray filtration shall be either at the option of the user or automatic as part of the selected mode of operation. A means of indicating which combination of additional filtration is in the X-ray beam shall be provided.
B. Table 1 - X-Ray Tube Voltage (kilovolt peak)

Design Operating Range

Measured Operating Potential

Minimum HVL (mm in Aluminum)

Subject to §4.4.7 of this Part and manufactured before June 10, 2006)

X-Ray Systems subject to §4.4.7 of this Part and manufactured on or after June 10, 2006)

Below 51

30

0.3

0.3

40

0.4

0.4

50

0.5

0.5

51 to 70

51

1.2

1.3

60

1.3

1.5

70

1.5

1.8

Above 70

71

2.1

2.5

80

2.3

2.9

90

2.5

3.2

100

2.7

3.6

110

3.0

3.9

120

3.2

4.3

130

3.5

4.7

140

3.8

5.0

150

4.1

5.4

C. Measuring Compliance. For capacitor energy storage equipment, compliance shall be determined with the maximum selectable quantity of charge per exposure.
D. Aluminum Equivalent of Material Between Patient and Image Receptor. Except when used in a CT X-ray system, the aluminum equivalent of each of the items listed in §4.4.7(E) of this Part [Table 2], which are used between the patient and the image receptor, may not exceed the indicated limits. Compliance shall be determined by X-ray measurements made at a potential of one hundred (100) kilovolts peak and with an X-ray beam that has an HVL specified in §4.4.7(B) of this Part [Table 1] for the potential. This requirement applies to front panel(s) of cassette holders and film changers provided by the manufacturer for patient support or for prevention of foreign object intrusions. It does not apply to screens and their associated mechanical support panels or grids.
E. Table 2 - Maximum Aluminum Equivalent (millimeters)

ITEM

Maximum Aluminum Equivalent (millimeters)

1. Front panel(s) of cassette holders (total of all)

1.2

2. Film panel(s) of film changer (total of all)

1.2

3. Cradle

2.3

4. Tabletop, stationary, without articulated joints

1.2

5. Tabletop, movable, without articulated joint(s) (including stationary subtop)

1.7

6. Tabletop, with radiolucent panel having one articulated joint

1.7

7. Tabletop, with radiolucent panel having two or more articulated joints

2.3

8. Tabletop, cantilevered

2.3

9. Tabletop, radiation therapy simulator

5.0

F. Modification of Certified Diagnostic X-ray Components and Systems
1. Diagnostic X-ray components and systems certified in accordance with 21 C.F.R. Part 1020 shall not be modified such that the component or system fails to comply with any applicable provision of this Part.
2. The owner of a diagnostic X-ray system who uses the system in a professional or commercial capacity may modify the system provided the modification does not result in the failure of the system or component to comply with the applicable requirements of this Part. The owner who causes such modification need not submit the reports required by this Subchapter, provided the owner records the date and the details of the modification in the system records and maintains this information, and provided the modification of the X-ray system does not result in a failure to comply with this Subchapter.
4.4.8Multiple Tubes

Where two (2) or more radiographic tubes are controlled by one (1) exposure switch, the tube or tubes which have been selected shall be clearly indicated prior to initiation of the exposure. This indication shall be both on the X-ray control panel and at or near the tube housing assembly which has been selected.

4.4.9Mechanical Support of Tube Head

The tube housing assembly supports shall be adjusted such that the tube housing assembly will remain stable during an exposure unless tube housing movement is a designed function of the X-ray system.

4.4.10Technique Indicators
A. For X-ray equipment capable of displaying technique factors, the technique factors to be used during an exposure shall be indicated before the exposure begins. If automatic exposure controls are used, the technique factors which are set prior to the exposure shall be indicated.
B. The requirement of §4.4.10(A) of this Part may be met by permanent markings on equipment having fixed technique factors. Indication of technique factors shall be visible from the operator's position except in the case of spot films made by the fluoroscopist.
C. The accuracy of the indicated kilovoltage peak (kVp) shall meet manufacturer specifications. In the absence of a manufacturer specification, kVp accuracy shall be within ± ten percent (10%).
4.4.11Structural Shielding

Structural shielding shall be provided whenever necessary to meet the requirements of §§1.7.1 and 1.8.1 of this Subchapter, in addition to specific requirements contained in other Parts of this Subchapter.

4.4.12Locks

All position locking, holding, and centering devices on X-ray system components and systems shall function as intended.

4.4.13Use of Calibrated Dosimetry System

Measurements required in §§4.10.1(A)(3), (4) and (5) of this Part shall be performed with a calibrated dosimetry system per manufacturer recommendations. The calibration of such a system shall be traceable to a national standard. The dosimetry system shall have been calibrated within the preceding two (2) years and records of calibration maintained for five (5) years for inspection by the Agency.

4.4.14Reports and Notifications of Radiation Medical Events
A. Other than events that result from intervention by a patient or human research subject, a registrant shall report any event in which the administration of ionizing radiation from a diagnostic radiation machine meets one (1) or more of the following criteria:
1. A patient or human research subject receives an unintended skin dose to the same area in a single procedure greater than two (2) Gy [two hundred (200) rads].
2. A patient or human research subject receives an unintended dose other than skin dose in a single procedure greater than:
a. Five (5) times the facility's established protocol, and > 0.5 Gy (50 rad) to any organ; or
b. Five (5) times the facility's established protocol, and > 0.05 Sv (5 rem) total effective dose.
3. Wrong patient or wrong site for the entire procedure when the resultant dose:
a. > 0.5 Gy (50 rad) to any organ; or
b. Total Effective dose is greater than or equal to ([GREATER THAN AND EQUAL TO]) 0.05 Sv (5 rem).
B. Any wrong patient or wrong site imaged regardless of dose received shall be reported, documented and addressed internally within the facility.
C. The registrant shall notify the Agency by telephone no later than the next business day after discovery of the radiation medical event.
1. All required notifications shall use Agency contact information specified in § 1.4 of this Subchapter.
D. The registrant shall submit a written report to the Agency, prepared by a Qualified Medical Physicist, to the Agency within fifteen (15) business days after discovery of the radiation medical event. The written report shall include:
1. The registrant's name;
2. Date of event and date discovered;
3. The estimated dose received;
4. The imaging procedure(s) performed;
5. The type of equipment in use (e.g., CT, fluoroscopy, radiographic, other);
6. The manufacturer and model of the unit used;
7. Why the event occurred;
8. How the event was discovered;
9. The effect, if any, on the individuals(s) who is the subject of the radiation medical event;
10. Actions, if any, that have been taken, or are planned, to prevent recurrence;
11. Certification that the registrant notified the individual (or the individual's responsible relative or guardian), and if not, why not; and
12. If there was notification, what information was provided to the individual.
E. The registrant shall provide a clinical summary of the radiation medical event to the prescribing physician and patient within fifteen (15) business days.
4.4.15Records of Radiation Medical Events

The registrant shall retain a record of a radiation medical event reported in accordance with §4.4.14 of this Part as part of the patient's permanent medical record.

216 R.I. Code R. 216-RICR-40-20-4.4

Adopted effective 1/1/2019
Amended effective 5/25/2022
Amended effective 11/28/2023