N.J. Admin. Code § 7:28-15.3

Current through Register Vol. 56, No. 24, December 18, 2024

Section 7:28-15.3 - General requirements for radiographic installations

(a) The provisions of this section are in addition to and not in substitution for the applicable provisions of N.J.A.C. 7:28.

(b) No person shall operate or permit the operation of any certified or uncertified radiographic x-ray equipment used in the healing arts unless a diagnostic type protective tube housing is provided.

(c) No person shall operate or permit the operation of any certified or uncertified radiographic x-ray equipment used in the healing arts unless a device is used to collimate the useful beam, and this device provides the same degree of protection as required of the diagnostic type protective tube housing.

1. Any new or used x-ray machine sold or otherwise transferred after July 1, 1969 shall be equipped with an adjustable, rectangular collimator fitted with a light field or laser system for delineating the edges of the collimated x-ray beam. The light field and/or laser system shall be operational. There shall be provided a means for stepless adjustment of the size of the x-ray field. The minimum field size at an SID of 100 centimeters (39.4 inches) shall be equal to or less than five centimeters by five centimeters (two inches by two inches). For equipment that employs a light field to define the x-ray field, the following criteria shall apply:

i. The light field shall have an average illumination of not less than 160 lux (15 foot candles) at 100 centimeters (39.4 inches) or at the maximum SID, whichever is less. The average illumination shall be based upon measurements made in the approximate center of each quadrant of the light field. Radiation therapy simulation systems are exempt from this requirement.

ii. The edge of the light field at 100 centimeters (39.4 inches) or at the maximum SID, whichever is less, shall have a contrast ratio, corrected for ambient lighting, of not less than four for beam-limiting devices designed for use on stationary equipment, and a contrast ratio of not less than three for beam-limiting devices designed for use on mobile and portable equipment.

iii. The total misalignment of the edges of the visually defined field with the respective edges of the x-ray field along either the length or width of the visually defined field shall not exceed two percent of the distance from the source to the center of the visually defined field when the surface upon which it appears is perpendicular to the axis of the x-ray beam.

iv. If a laser system is used to delineate the edges of the collimated x-ray beam, this source shall provide illumination levels sufficient to determine the collimated edges under ambient light conditions.

2. A system not requiring a light-beam collimator shall have an assortment of removable, fixed-aperture, beam-limiting devices (diaphragms) sufficient to meet each combination of image receptor size and SID used. Each fixed-aperture beam-limiting device shall be clearly and permanently marked to indicate the image receptor size and SID for which it is designed. Each fixed-aperture beam-limiting device shall limit the size of the x-ray field to the size of the image receptor. It shall be the responsibility of the operator to ensure that the correct combination of diaphragm and image receptor size is used during the radiographic procedure.

3. A single-purpose x-ray system, such as chest x-ray equipment, may use a fixed collimator provided the x-ray field does not exceed the size of the image receptor and the beam is fully intercepted by the image receptor. If such an x-ray system is equipped with a light field system, it shall be exempt from (c)1 above.

(d) No person shall operate or permit the operation of any certified or uncertified radiographic x-ray equipment used in the healing arts unless the beam alignment and distance measurements meet the following requirements:

1. Certified x-ray systems shall be provided with a means or device to indicate when the axis of the x-ray beam is perpendicular to the plane of the image receptor;

2. The center of the x-ray field shall be aligned with respect to the center of the image receptor to within two percent of the SID when the x-ray beam is perpendicular to the plane of the image receptor; and

3. A means shall be provided to indicate the SID to within two percent. If it is a fixed SID, the distance shall be indicated on the unit with a permanent marking.

(e) No person shall operate or permit the operation of any certified or uncertified radiographic x-ray equipment used in the healing arts unless the x-ray filtration and beam quality meet the following requirements:

1. The amount of total filtration permanently in the useful beam shall provide the minimum half-value layer specified in the following table:

TABLE 1

TABLE OF HALF VALUE LAYERS

Designed OperatingRange (kVp)	Measured	Minimum
operating	half-value
potential	layer (HVL)
(kVp)	(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

(f) No person shall operate or permit the operation of any certified or uncertified radiographic x-ray equipment used in the healing arts unless the exposure control and exposure timer meet the following requirements:

1. A device shall be provided to terminate the exposure at a preset time interval, preset product of current and time, preset number of pulses, or preset radiation exposure.

i. Except during serial radiography, the operator shall be able to terminate the exposure at any time during an exposure greater than one-half second.

ii. Except during serial radiography, termination of the exposure shall cause automatic resetting of the timer to its initial setting or to zero.

iii. Except during serial radiography, it shall not be possible to make an exposure when the timer is set to a zero or off position, if either position is provided.

iv. During serial radiography, the operator 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;

2. The x-ray control panel shall include a means for indicating x-ray tube voltage (kVp), tube current (mA), and time setting or the product of the tube current and time setting in milliampere-seconds (mAs);

3. The x-ray control panel shall provide visual indication to the operator whenever x-rays are produced. Certified equipment shall also provide audible indication to the operator while x-rays are produced or on termination of the exposure;

4. The technique factors to be used during an exposure shall be indicated on the control panel before the exposure begins. If automatic exposure controls are used, the technique factors which are set prior to the exposure shall be indicated. For equipment having fixed technique factors, this requirement shall be met by permanent markings;

5. The exposure control switch when depressed shall not energize the x-ray tube when the timer is in the "off" or "zero" position;

6. The exposure control switch shall be arranged so that it can only be operated when the operator is within a shielded area; and

7. For equipment that provides an automatic exposure control, the following requirements shall be met:

i. There shall be a device on the control panel that indicates when this mode of operation is selected;

ii. For certified equipment only, a signal audible and visible to the operator shall indicate when an exposure has been terminated; and

iii. For uncertified equipment only, a signal visible to the operator shall indicate when the exposure has terminated.

(g) No person shall operate or permit the operation of any certified or uncertified radiographic x-ray equipment used in the healing arts unless the accuracy, reproducibility and linearity meet the following requirements:

1. The timer accuracy shall not exceed the limits specified by the manufacturer. In the absence of manufacturer's specifications, the deviation shall not exceed 10 percent of the indicated value;

2. The following timer reproducibility requirements shall apply:

i. For certified equipment only, the coefficient of variation of the timer reproducibility shall not exceed 0.05 for any specific combination of selected technique factors.

ii. For uncertified equipment only, the coefficient of variation of the timer reproducibility shall not exceed 0.07 for any specific combination of selected technique factors;

3. The following exposure reproducibility requirements shall apply:

i. For certified equipment only, the coefficient of variation of radiation exposure reproducibility shall not exceed 0.05 for any specific combination of selected technique factors;

ii. For uncertified equipment only, the coefficient of variation of radiation exposure reproducibility shall not exceed 0.07 for any specific combination of selected technique factors;

4. The kVp accuracy shall not exceed the limits specified by the manufacturer. In the absence of manufacturer's specifications, the deviation shall not exceed 10 percent of the indicated value;

5. The kVp reproducibility shall not exceed a coefficient of variation of 0.05; and

6. The following linearity requirements apply to x-ray equipment which allows a choice of x-ray tube current settings and is operated on a power supply as specified by the manufacturer for any fixed x-ray tube potential within the range of 40 percent to 100 percent of the maximum rating.

i. For x-ray equipment having independent selection of x-ray tube current (mA), the average ratios of exposure to the indicated milliampere-seconds product (mR/mAs) or (C/kg/mAs) obtained at any two consecutive tube current settings shall not differ by more than 0.10 times their sum.

ii. For equipment manufactured after May 3, 1994, x-ray equipment having a combined x-ray tube current-exposure time product (mAs) selector, the average ratios of exposure to the indicated milliampere-seconds product (mR/mAs) or (C/kg/mAs) values obtained at any two consecutive mAs selector settings shall not differ by more than 0.10 times their sum.

iii. The average exposure ratio for (g)6i and ii above shall be expressed as follows:

Data in image

(h) No person shall operate or permit the operation of a certified or uncertified multiple-tube installation where a control panel can energize more than one x-ray tube unless the following additional requirements are met: (Interventional biplane radiographic systems shall be exempted from these additional requirements.)

1. Only one radiographic tube shall be capable of activation at any time;

2. Where two or more radiographic tubes are controlled by one exposure switch, the radiographic tube which has been selected shall be clearly indicated to the operator prior to initiation of the exposure. Certified units only shall be provided with such an indicator on both the x-ray control panel and at or near the radiographic tube housing assembly which has been selected; and

3. A radiographic tube shall be energized only when that specific radiographic tube is selected.

(i) No person shall operate or permit the operation of any certified radiographic x-ray equipment that has been provided with positive beam limitation (PBL) unless the following requirements are met:

1. When provided, positive beam limitation (PBL) shall function as described in (i)2 below whenever all the following conditions are met:

i. The image receptor is inserted into a permanently mounted cassette holder;

ii. The image receptor length and width are each less than 50 centimeters (20 inches);

iii. The x-ray beam axis is within plus or minus three degrees of vertical and the SID is 90 centimeters (35.5 inches) to 130 centimeters (51 inches) inclusive; or the x-ray beam axis is within plus or minus three degrees of horizontal and the SID is 90 centimeters (35.5 inches) to 205 centimeters (81 inches) inclusive;

iv. The x-ray beam is perpendicular to the plane of the image receptor to within plus or minus three degrees; and

v. Neither tomographic nor stereoscopic radiography is being performed;

2. When positive beam limitation (PBL) is provided it shall prevent the production of x-rays whenever:

i. Either the length or width of the x-ray field in the plane of the image receptor differs from the corresponding image receptor dimensions by more than three percent of the SID;

ii. The sum of the differences, without regard to sign, between the length and width of the x-ray field in the plane of the image receptor and the corresponding dimensions of the image receptor exceeds four percent of the SID; or

iii. The beam-limiting device is at an SID for which PBL is not designed for sizing.

3. Compliance with (i)2 above shall be determined when the equipment indicates that the beam axis is perpendicular to the plane of the image receptor and the provisions of (i)1 above are met. Determination of compliance shall be no sooner than five seconds after insertion of the image receptor;

4. If a capability for overriding PBL in case of system failure and for servicing the system is provided, it shall comply with the following:

i. This override shall be for all SID and image receptor sizes;

ii. A key shall be required to defeat the PBL;

iii. The key shall remain in place during the entire time the PBL system is overridden; and

iv. Each key switch or key shall be clearly and durably labeled as follows:

For X-ray Field Limitation System Failure

The override capability is considered accessible to the operator if it is referenced in the operator's manual or in other material intended for the operator if its location is such that the operator would consider it part of the operational controls.

5. When provided, the positive beam limitation system shall be capable of operation, at the discretion of the operator, in such a manner that the size of the field may be made smaller than the size of the image receptor through stepless adjustment of the field size. The minimum field size at an SID of 100 centimeters (39.4 inches) shall be equal to or less than five centimeters by five centimeters (two inches by two inches); and

6. When provided, the positive beam limitation system shall be so designed that if a change in image receptor does not cause an automatic return to the positive beam limitation function as described in (i)2 above, then any change of image receptor size or SID must cause the automatic return.

(j) No person shall operate or permit the operation of certified or uncertified mobile or portable radiographic x-ray equipment unless the following requirements are met:

1. These requirements are in addition to and not in substitution for the applicable requirements of this subchapter;

2. The equipment shall be provided with a collimator and a spacer device to limit the source-to-skin distance to not less than 30 centimeters (12 inches);

3. If the equipment was manufactured with a device to measure the SID, the device shall be present to measure the SID and the device shall indicate the SID to within two percent;

4. The exposure control switch shall be of the dead-man type and shall be so arranged that the operator can stand at least six feet from the patient for all exposures. The exposure control switch when depressed shall not energize the x-ray tube when the timer is in the "off" or "0" position;

5. A mobile or portable radiographic unit used routinely in one location shall be considered a permanent installation and shall comply with the requirements of N.J.A.C. 7:28-15.10; and

6. No person shall operate or permit the operation of certified or uncertified mobile or portable equipment unless the person operating the equipment is protected with a lead apron of at least 0.25 mm lead equivalent.

(k) No person shall operate or permit the operation of certified or uncertified ionizing-radiation-producing podiatric x-ray equipment unless the following requirements are met:

1. These requirements are in addition to and not in substitution for the applicable requirements of this subchapter; and

2. Certified and uncertified podiatric x-ray equipment shall be provided with an exposure control switch which will allow the operator to stand at least six feet (1.8 meters) from the patient or behind a protective barrier. The requirement set forth in this paragraph shall supersede the requirement in (f)6 above.

(l) No person shall operate or permit the operation of medical radiographic x-ray equipment used in the healing arts unless the registrant has developed and continuously implements a quality assurance program that meets the applicable requirements of N.J.A.C. 7:28-22, Quality Assurance Programs for Medical Diagnostic X-ray Installations.

N.J. Admin. Code § 7:28-15.3

Amended by R.2001 d.37, effective 1/16/2001.
See: 32 New Jersey Register 1459(a), 33 New Jersey Register 292(b).
Added (l).