16 Del. Admin. Code § 4465-H-4.0
As used in this Part, the following definitions apply:
"Accessible surface" means the external or outside surface of the enclosure or housing provided by the manufacturer. This includes the high-voltage generator, doors, access panels, latches, control knobs, and other permanently mounted hardware and including the plane across the exterior edge of any opening.
"Analytical x-ray equipment" means equipment that generates (by electronic means) and uses ionizing radiation for the purpose of examining the microstructure of materials, i.e. diffraction and spectroscopy (including fluorescence).
"Annual" means approximately every 12 months and not to exceed 14 months.
"Baggage unit". See "Security Screening Unit".
"Beam-port" means an opening on the x-ray apparatus designed to emit a primary beam. This does not include openings on baggage units.
"Cabinet radiography" means industrial radiography using radiation machines not subject to FDA performance standard for cabinet x-ray systems, in an enclosed, interlocked cabinet in which the portion of a material being irradiated is contained, and in which:
i. The radiation machine will not operate unless all openings are closed with interlocks activated;
ii. The cabinet is shielded such that every location on the exterior meets the conditions for an unrestricted area as defined in Part D of these regulations; and
iii. The cabinet is constructed or arranged as to exclude the entrance of any part of the body of an individual during irradiation.
"Cabinet x-ray system" means an x-ray system with the x-ray tube installed in an enclosure which, independently of existing architectural structures except the floor on which it may be placed, is intended to contain at least that portion of a material being irradiated, provide radiation attenuation, and exclude personnel from its interior during generation of x radiation. An x-ray tube used within a shielded part of a building, or x-ray equipment which may temporarily or occasionally incorporate portable shielding is not a cabinet x-ray system.
"Cathode ray tube" means any device used to accelerate electrons for demonstration or research purposes, except where such cathode ray tube is incorporated into a television or display monitor that is subject to, and has met applicable federal radiation safety performance standards in 21 CFR 1010 and 1020.10.
"Certified cabinet x-ray system" means a RGD certified by the manufacturer in accordance with 21 CFR 1010.2 as being manufactured and assembled pursuant to the provisions of applicable federal radiation safety performance standards in 21 CFR 1010 and 1020.40.
"Certifiable cabinet x-ray system" means an existing uncertified RGD that has been modified to meet the certification requirements specified in 21 CFR 1020.40.
"Closed-beam x-ray equipment" means a system in which the beam path cannot be entered by any part of the body during normal operation.
"Cold-cathode gas discharge tube" means an electronic device in which electron flow is produced and sustained by ionization of contained gas atoms and ion bombardment of the cathode.
"Collimator" means a device for restricting the useful radiation in one or more directions.
"Cone Beam CT" (CBCT) means a method of computed tomography that creates a three-dimensional cone-shaped beam that circles the object once to generate an image.
"Control panel" means a device containing means for regulation and activation of a RGD or for the preselection and indications of operating factors.
"Emergency procedure" means the written pre-planned steps to be taken in the event of actual or suspected exposure of an individual in excess of administrative or regulatory limits. This procedure shall include the names and telephone numbers of individuals to be contacted as well as directives for processing the film badge or other personnel monitoring devices.
"Fail-safe design" means a design in which all realistically anticipated failures of indicators or safety components result in a condition in which individuals are safe from exposure to radiation. For example, if a light indicating "X-RAY ON" fails, the production of x-rays shall be prevented, or if a shutter status indicator fails, the shutter shall close.
"General-use system" means a personnel screening system that delivers an effective dose equal to or less than 0.25 microsieverts (uSv), or 25 microRem (urem) per screening. Given proper justification and certain restrictions, general-use systems may be operated without specific controls that would limit the number of individuals scanned or the number of scans per individual in a year.
"Hand-held x-ray system" means a portable instrument that is designed to operate when held in the hand, e.g., hand-held XRF analytical devices.
"Industrial radiography" means an examination of the structure of materials by nondestructive methods utilizing ionizing radiation to make radiographic images.
"Interlock" means a device or engineered system that precludes access to an area of radiation hazard either by preventing entry or by automatically removing or inactivating the hazard.
"Leakage radiation" means all radiation coming from within the source housing, except the useful beam.
"Limited-use system" means a personnel screening system that is capable of delivering an effective dose greater than 0.25 microsieverts (uSv), or 25 microRem (urem) per screening but cannot exceed an effective dose of 10 microsieverts (uSv), or 1 microRem (urem) per screening. Limited-use systems require additional controls and documentation to ensure that annual individual dose limits required by Part H, subsection 12.5 are not exceeded.
"Local components" means parts of a RGD x-ray system and include areas that are struck by x-rays such as radiation source housings, beam port and shutter assemblies, collimators, sample holders, cameras, goniometers, detectors, and shielding, but do not include power supplies, transformers, amplifiers, readout devices, and control panels.
"Mobile equipment". See "Radiation generating device".
"Normal operating procedures" mean step-by-step instructions necessary to accomplish the task. These procedures may include sample insertion and manipulation, equipment alignment, routine maintenance by the registrant, and data recording procedures, which are related to radiation safety.
"Open-beam x-ray equipment" means an open-beam x-ray system in which the beam path could be entered by any part of the body at any time.
"Personnel security screening system" means any x-ray equipment used on humans for security evaluation.
"Portable equipment". See "Radiation generating device".
"Primary beam" means the ionizing radiation coming directly from the radiation source through a beam port into the volume defined by the collimation system.
"Qualified expert" means an individual who has satisfactorily fulfilled the training and experience requirements consistent with achieving a level of competency sufficient to function effectively in the position for which registration is sought, in accordance with 4465 Part B. Such individuals must demonstrate to the satisfaction of the Agency their qualifications, for example, individuals certified in the appropriate field by the American Board of Radiology, or the American Board of Health Physics, or the American Board of Medical Physics, or those having equivalent qualifications.
"Radiation generating device (or RGD)" means any system, device, subsystem, or component thereof, which may generate x-rays or particle radiation between 5 keV and 1 MeV, and not intended for healing arts use for humans or animals. A RGD may be fixed or portable, such as:
i. Mobile means RGD equipment mounted on a permanent base with wheels and/or casters for moving while completely assembled;
ii. Portable means RGD equipment designed to be hand-carried;
iii. Stationary means RGD equipment that is installed or placed in a fixed location; or
iv. Transportable means RGD equipment to be installed in a vehicle or that may be readily disassembled for transport or use in a vehicle.
"Radiation Safety Officer (RSO)" means an individual as defined in Part A, Appendix C of these regulations.
"Radiation source (or x-ray tube) housing" means that portion of an x-ray system which contains the x-ray tube and/or secondary target. Often the housing contains radiation shielding material or inherently provides shielding.
"Radiograph" means a permanent film or digital image produced on a sensitive surface by a form of radiation other than direct visible light or other forms of non-ionizing radiation.
"Radiography" is the process of creating radiographic images.
"Safety device" means a device, interlock or system that prevents the entry of any portion of an individual's body into the primary x-ray beam or that causes the beam to shut off upon entry into its path.
"Scattered radiation" means radiation that has been deviated in direction and / or energy by passing through matter.
"Security screening unit" means a non-human use open-beam or cabinet x-ray system with accessible openings designed for the detection of weapons, bombs, or contraband concealed in baggage, mail, packages or other commodities or structure.
"Shielded room" means a room housing a RGD where, with the RGD at maximum techniques, the exterior room environs meets the unrestricted area limits of 0.02 millisieverts (mSv), or 2 milliRem (mrem) in any one hour and 1 millisieverts (mSv), or 100 milliRem (mRem) in a year at 30 cm from the barrier. A shielded room does not include a RGD which meet the definition of cabinet x-ray systems.
"Shutter" means a moveable device used to block the useful (or primary) beam emitted from an x-ray tube assembly.
"Source" means the point of origin of the radiation, for example, the focal spot of an x-ray tube.
"Stationary equipment". See "Radiation generating device".
"Stray radiation" means the sum of leakage and scatter radiation.
"Warning device" means a visible or audible signal that warns individuals of a potential radiation hazard.
"X-ray generator" means that portion of an x-ray system which provides the accelerating high voltage and current for the x-ray tube.
"X-ray gauge" means an x-ray producing device designed and manufactured for the purpose of detecting, measuring, gauging, or controlling thickness, density, level, or interface location.
16 Del. Admin. Code § 4465-H-4.0