Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-66 - Radiation Generating Equipment › Section 3701:1-66-05 - Medical general purpose radiographic equipment

Current through all regulations passed and filed through July 1, 2024
The requirements of this rule do not apply to
				radiation-generating equipment used for dental intraoral or panoral,
				mammography, bone densitometry, computed tomography, fluoroscopy or spot film
				imaging, and equipment used in radiation therapy
				.
(A) General purpose radiographic equipment
			 shall meet the following equipment standards:
(1) A means shall be provided for limiting
			 the x-ray beam to the image receptor and area of clinical interest;
(2) For radiographic equipment having a
			 variable x-ray field limitation device, the limitation device shall have means
			 for independent stepless adjustment of both the length and width of the x-ray
			 field;
(3) For
			 radiographic equipment that employs a light field for visually defining the
			 perimeter of the x-ray field, the light source shall be functional and 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 per cent of the source-to-image
			 distance (SID);
(4) In
			 addition to the requirements of paragraphs (A)(1), (A)(2) and (A)(3) of this
			 rule stationary radiographic equipment having a variable x-ray field limitation
			 device shall have:
(a) A means provided to
			 indicate when the axis of the x-ray beam is perpendicular to the plane of the
			 image receptor;
(b) A means
			 provided to align the center of the x-ray field with respect to the center of
			 the image receptor to within two per cent of the SID, when the x-ray beam is
			 perpendicular to the plane of the image receptor;
(c) A means to indicate the SID to within two
			 per cent. If it is a fixed SID, the distance shall be indicated with a
			 permanent marking;
(d) The beam
			 limiting device indicate numerically the field size in the plane of the image
			 receptor to which it is adjusted and be accurate within two per cent of the
			 SID; and
(e) Compliance
			 measurements made to discrete SID's and image receptor dimensions in common
			 clinical use, or at any other specific dimensions at which the beam-limiting
			 device or its associated diagnostic x-ray system is uniquely designed to
			 operate;
(5)
									General
			 purpose
									radiographic equipment designed with only one image
			 receptor size at a fixed SID shall have:
(a) A
			 means to limit the field at the plane of the image receptor to dimensions no
			 greater than those of the image receptor, and to align the center of the x-ray
			 field with the center of the image receptor within two per cent of the SID;
			 or
(b) A means to align the field
			 such that the x-ray field at the plane of the image receptor shall not extend
			 beyond any edge of the image receptor;
(6)
									General
			 purpose
									radiographic equipment designed with multiple
			 removable or selectable fixed apertures
			 shall have:
(a) A means to limit the x-ray
			 field in the plane of the receptor so that such field does not exceed each
			 dimension of the image receptor by more than two per cent of the SID when the
			 axis of the x-ray beam is perpendicular to the plane of the image
			 receptor;
(b) A means to align the
			 center of the x-ray field with the center of the image receptor to within two
			 per cent of the SID or for equipment uniquely designed where the beam axis is
			 intended to be offset from the center of the image receptor, the x-ray field at
			 the plane of the image receptor shall not extend beyond the image receptor;
			 and
(c) Paragraphs (A)(6)(a) and
			 (A)(6)(b) of this rule may be met with either:
(i) An assortment of removable,
			 fixed-aperture, beam limiting devices sufficient to meet the requirement for
			 each combination of image receptor size and SID for which the unit is designed
			 with each such device having clear and permanent markings to indicate the image
			 receptor size and SID for which it is designed; or
(ii) A beam-limiting device having multiple
			 fixed apertures sufficient to meet the requirement for each combination of
			 image receptor size and SID for which the unit is designed. Permanent, clearly
			 legible markings shall indicate the image receptor size and SID for which each
			 aperture is designed and shall indicate which aperture is in position for
			 use;
(7) If a positive beam limitation (PBL) device is used, it shall meet the following
			 additional requirements:
(a) The PBL shall
			 prevent the production of x-rays when any of the following conditions are met:
(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 per cent of the SID, except as permitted
			 by paragraph (A)(7)(c) of this rule;
(ii) The sum of the length and width
			 differences as stated in paragraph (A)(7)(a)(i) of this rule without regard to
			 sign exceeds four per cent of the SID; or
(iii) The beam-limiting device is at an SID
			 for which PBL is not designed for sizing;
(b) Compliance with paragraph (A)(7)(a) of
			 this rule shall be determined:
(i) When the
			 equipment indicates that the beam axis is perpendicular to the plane of the
			 image receptor; and
(ii) No sooner
			 than five seconds after insertion of the image receptor;
(c) The PBL system shall be capable of
			 operation, at the discretion of the operator, such 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 a SID of one hundred
			 centimeters shall be equal to or less than five centimeters by five
			 centimeters;
(d) The PBL system
			 shall be designed such that if a change in image receptor does not cause an
			 automatic return to PBL function as described in paragraph (A)(7)(a) of this
			 rule, then any change of image receptor size or SID must cause an automatic
			 return; and
(e) The PBL system
			 shall function as described in paragraph (A)(7) of this rule 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
			 less than fifty centimeters;
(iii)
			 The x-ray beam axis is within plus or minus three degrees of vertical in any
			 direction and the SID is ninety to one hundred thirty centimeters inclusive; or
			 the x-ray beam axis is within plus or minus three degrees of horizontal and the
			 SID is ninety to two hundred five centimeters inclusive;
(iv) The x-ray beam axis 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;
(8) 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 to the
			 image receptor;
(9) For
			 radiographic equipment that provides manual exposure control, the operator
			 shall be able to terminate the exposure at any time unless:
(a) The exposure is 0.5 second or less;
			 or
(b) During serial radiography,
			 means are provided to permit completion of any single exposure of the series in
			 progress;
(10) In the case of radiographic equipment
			 that provides automatic exposure control:
(a)
			 The control panel shall indicate when this mode of operation is
			 selected;
(b) The density setting
			 and automatic exposure control detector positions that are selected prior to
			 the exposure shall be indicated; and
(c) A visible signal shall indicate when an
			 exposure has been terminated at the back-up limit. Manual resetting shall be
			 required before further automatic timed exposures can be made;
(11) The x-ray control panel shall
			 provide visual indication when x-rays are produced and an audible signal shall
			 indicate when the exposure has terminated;
(12) The exposure control switch shall meet
			 the following requirements:
(a) The switch
			 shall be a "dead-man switch;"
(b)
			 It shall not be possible to initiate an exposure when the timer is set to the
			 "zero" or "off" position if either position is provided; and
(c) The switch shall be permanently mounted
			 in a protected area so that it cannot be operated outside the protected area
			 except for portable, mobile, or veterinary radiation-generating equipment.