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(3) Electronic product means: (1) Any manufactured or assembled product which, when in operation:
(i) Contains or acts as part of an elecronic circuit and
(ii) Emits (or in the absence of effecive shielding or other controls would mit) electronic product radiation, or
(2) Any manufactured or assembled irticle that is intended for use as a component, part, or accessory of a product described in paragraph (j)(1) of this section and which, when in operition, emits (or in the absence of effective shielding or other controls would emit) such radiation. (k) Electronic product radiation means: (1) Any ionizing or nonionizing electromagnetic or particulate radiation,
tion 534 of the Federal Food, Drug, and Cosmetic Act.
(m) Infrasonic, sonic (or audible) and ultrasonic waves refer to energy transmitted as an alteration (pressure, particle displacement or density) in a property of an elastic medium (gas, liquid or solid) that can be detected by an instrument or listener.
(n) Manufacturer means any person engaged in the business of manufacturing, assembling, or importing electronic products.
(0) Model means any identifiable, unique electronic product design, and refers to products having the same structural and electrical design characteristics and to which the manufacturer has assigned a specific designation to differentiate between it and other products produced by that manufacturer.
(p) Model family means products having similar design and radiation characteristics but different manufacturer model numbers.
(2) Any sonic, infrasonic, or ultrasonic wave that is emitted from an electronic product as the result of the operation of an electronic circuit in such product.
(1) Federal standard means a performance standard issued pursuant to sec
(q) Modified model means a product that is redesigned so that actual or potential radiation emission, the manner of compliance with a standard, or the manner of radiation safety testing is affected.
(r) Particulate radiation is defined as:
(1) Charged particles, such as protons, electrons, alpha particles, or heavy particles, which have sufficient kinetic energy to produce ionization or atomic or electron excitation by collision, electrical attractions or electrical repulsion; or
(2) Uncharged particles, such as neutrons, which can initiate a nuclear transformation or liberate charged particles having sufficient kinetic energy to produce ionization or atomic or electron excitation.
(s) Phototherapy product means any ultraviolet lamp, or product containing such lamp, that is intended for irradiation of any part of the living human body by light in the wavelength range of 200 to 400 nanometers, in order to perform a therapeutic function.
(t) Purchaser means the first person who, for value, or as an award or prize, acquires an electronic product for purposes other than resale, and includes a person who leases an electronic product for purposes other than subleasing.
(u) State means a State, the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, Guam, and American Samoa.
search, educational). Particulate radiation and ionizing electro
magnetic radiation: Electron microscopes. Neutron generators.
(b) Examples of electronic products which may emit ultraviolet, visible, infrared, microwaves, radio and low frequency electromagnetic radiation include: Ultraviolet:
Biochemical and medical analyzers.
White light devices.
Dryers, ovens, and heaters.
(c) Examples of electronic products which may
emit coherent electromagnetic radiation produced by stimulated emission include: Laser: Art-form, experimental and educational
devices. Biomedical analyzers. Cauterizing, burning and welding devices. Cutting and drilling devices. Communications transmitters.
Rangefinding devices. Maser:
(d) Examples of electronic products which may emit infrasonic, sonic, and ultrasonic vibrations resulting from operation of an electronic circuit include:
[60 FR 48380, Sept. 19, 1995; 61 FR 13422, Mar. 27, 1996)
Subpart B-Statements of Policy
and Interpretation § 1000.15 Examples of electronic prod
ucts subject to the Radiation Control for Health and Safety Act of
1968. The following listed electronic products are intended to serve as illustrative examples of sources of electronic product radiation to which the regulations of this part apply.
(a) Examples of electronic products which may emit x-rays and other ionizing electromagnetic radiation, electrons, neutrons, and other particulate radiation include: Ionizing electromagnetic radiation:
Sound amplification equipment.
Subpart C-Radiation Protection
should be routinely considered for use. As a basis for judgment, specific area testicular shielding should be considered for all examinations of male patients in which the pubic symphysis will be visualized on the film;
(3) Specific area gonad shielding should never be used as a substitute for careful patient positioning, the use of correct technique factors and film processing, or proper beam limitation (confinement of the x-ray field to the area of diagnostic interest), because this could result in unnecessary doses to other sensitive tissues and could adversely affect the quality of the radiograph; and
(4) Specific area gonad shielding should provide attenuation of x-rays at least equivalent to that afforded by 0.25 millimeter of lead.
(b) The clinical objectives of the examination will not be compromised.
(1) Specific area testicular shielding usually does not obscure needed information except in a few cases such as oblique views of the hip, retrograde urethrograms and
voiding cystourethrograms, visualization the rectum and, occasionally, the pubic symphysis. Consequently, specific area testicular shielding should be considered for use in the majority of x-ray examinations of male patients in which the testes will lie within the primary beam or within 5 centimeters of its edge. It is not always possible to position shields on male patients so that no bone is obscured. Therefore, if all bone structure of the pelvic area must be visualized for a particular patient, the use of shielding should be carefully evaluated. The decision concerning the applicability of shielding for an individual patient is dependent upon consideration of the patient's unique anthropometric characteristics and the diagnostic information needs of the examination.
(2) The use of specific area ovarian shielding is frequently impractical at present because the exact location of the ovaries is difficult to estimate, and the shield may obscure visualization of portions of adjacent structures such as the spine, ureters, and small and large bowels. However, it may be possible for
$1000.50 Recommendation for the use
of specific area gonad shielding on patients during medical diagnostic X-ray procedures. Specific area gonad shielding covers in area slightly larger than the region of the gonads. It may therefore be used without interfering with the objectives of the examination to protect the germinal tissue of patients from radiation exposure
may cause genetic mutations during many medical x-ray procedures in which the gonads lie within or are in close proximity to the
-ray field. Such shielding should be provided when the following conditions exist:
(a) The gonads will lie within the prinary x-ray field, or within close proxmity (about 5 centimeters), despite proper beam limitation. Except as provided in paragraph (b) or (c) of this section:
(1) Specific area testicular shielding should always be used during those examinations in which the testes usually are in the primary x-ray field, such as examinations of the pelvis, hip, and apper femur;
(2) Specific area testicular shielding may also be warranted during other examinations of the abdominal region in which the testes may lie within or in close proximity to the primary x-ray field, depending upon the size of the patient and the examination techniques and equipment employed. Some examples of these are: Abdominal, lumbar spine and lumbosacral spine examinations, intravenous pyelograms, and abdominal scout film for barium enemas and upper GI series. Each x-ray facility should evaluate its procedures, techniques, and equipment and compile a list of such examinations for which specific area testicular shielding
2.6 O to 4
2.5 5 to 9
2.5 10 to 14
2.6 15 to 19
2.7 2.6 20 to 24
2.2 25 to 29
1.4 30 to 34
.6 35 to 39
.2 40 to 44
2 45 to 49
0 50 to 54
0 55 to 64
0 Over 65
0 Derived from data published by the National Center for Health Statistics, "Final Natality Statistics 1970," HRA 741120, vol. 22, No. 12, Mar. 20, 1974.
(2) Quality assurance means the planned and systematic actions that provide adequate confidence that a diagnostic x-ray facility will produce consistently high quality images with minimum exposure of the patients and healing arts personnel. The determination of what constitutes high quality will be made by the facility producing the images. Quality assurance actions include both “quality control” techniques and “quality administration" procedures.
(3) Quality assurance program means an organized entity designed to provide "quality assurance" for a diagnostic radiology facility. The nature and extent of this program will vary with the size and type of the facility, the type of examinations conducted, and other factors.
(4) Quality control techniques are those techniques used in the monitoring (or testing) and maintenance of the components of an x-ray system. The quality control techniques thus are concerned directly with the equipment. (5) Quality administration procedures
those management actions intended to guarantee that monitoring techniques are properly performed and evaluated and that necessary corrective measures are taken in response to monitoring results. These procedures provide the organizational framework for the quality assurance program.
(6) X-ray system means an assemblage of components for the controlled production of diagnostic images with irays. It includes minimally an x-ray high voltage generator, an x-ray control, a tube-housing assembly, a beamlimiting device, and the necessary supporting structures. Other components that function with the system, such as image receptors, image processors. view boxes, and darkrooms, are also parts of the system.
(c) Elements. A quality assurance program should contain the elements listed in paragraphs (c)(1) through (10) of this section. The extent to which each element of the quality assurance program is implemented should be determined by an analysis of the facility's objectives and resources conducted by its qualified staff or by qualified outside consultants. The extent of implementation should be determined on the
[41 FR 30328, July 23, 1976; 41 FR 31812, July 30, 1976]
§ 1000.55 Recommendation for quality
assurance programs in diagnostic
radiology facilities. (a) Applicability. Quality assurance programs as described in paragraph (c) of this section are recommended for all diagnostic radiology facilities.
(b) Definitions. As used in this section, the following definitions apply:
(1) Diagnostic radiology facility means any facility in which an X-ray system(s) is used in any procedure that involves irradiation of any part of the human body for the purpose of diagnosis or visualization. Offices of individual physicians, dentists, podiatrists, and chiropractors, as well as mobile laboratories, clinics, and hospitals are all examples of diagnostic radiology facilities.
zis of whether the expected benefits
radiation exposure reduction, imved image quality, and/or financial rings will compensate for the reirces required for the program. 1) Responsibility. (i) Responsibility d authority for the overall quality surance program as well as for moniing, evaluation, and corrective asures should be specified and rerded in a quality assurance manual. ii) The owner or practitioner in arge of the facility has primary reonsibility for implementing and tintaining the quality assurance proam. iii) Staff technologists will genally be delegated a basic quality asrance role by the practitioner in arge. Responsibility for specific ality control monitoring and mainnance techniques or quality adminisation procedures may be assigned, ovided that the staff technologists e qualified by training or experience r these duties. The staff techslogists should also be responsible for entifying problems or potential probms requiring actions beyond the level
their training. They should bring iese problems to the attention of the ractitioner in charge, or his or her presentative, so that assistance in blving the problems may be obtained om inside or outside the facility. (iv) In facilities where they are availble, physicists, supervisory techologists, or quality control techologists should have a major role in he quality assurance program. Such pecialized personnel may be assigned esponsibility for day-to-day adminisration of the program, may carry out nonitoring duties beyond the level of raining of the staff technologist or, if lesired by the facility, may relieve the taff technologists of some or all of jheir basic monitoring duties. Staff service engineers may also be assigned responsibility for certain preventive or corrective maintenance actions.
(V) Responsibility for certain quality control techniques
corrective measures may be assigned to personnel qualified by training or experience, such as consultants or industrial representatives, from outside of the facility, provided there is a written agreement clearly specifying these services.
(vi) In large facilities, responsibility for long-range planning of quality assurance goals and activities should be assigned to a quality assurance committee as described in paragraph (c)(9) of this section.
(2) Purchase specifications. Before purchasing new equipment, the staff of the diagnostic radiology facility should determine the desired performance specifications for the equipment. Initially, these specifications may be stated in terms of the desired performance of the equipment, or prospective vendors may be informed solely of the functions the equipment should be able to perform and asked to provide the performance specifications of items from their equipment line that can perform these functions. In either case, the responses of the prospective vendors should serve as the basis for negotiations to establish the final purchase specifications, taking into account the state of the art and balancing the need for the specified performance levels with the cost of the equipment to meet them. The final purchase specifications should be in writing and should include performance specifications. The availability of experienced service personnel should also be taken into consideration in making the final purchase decisions. Any understandings with respect to service personnel should be incorporated into the purchase specifications. After the equipment is installed, the facility should conduct a testing program, as defined in its purchase specificationsto
that the equipment meets the agreed upon specifications, including applicable Federal and State regulatory requirements. The equipment should not be formally accepted until any necessary corrections have been made by the vendor. The purchase specifications and the records of the acceptance testing should be retained throughout the life of the equipment for comparison with monitoring results in order to assess continued acceptability of performance.
(3) Monitoring and maintenance. A routine quality control monitoring and maintenance system incorporating state-of-the-art procedures should be established and conducted on a regular schedule. The purpose of monitoring is