classified for reasons of national security shall not be included in the application. Except as indicated above, the application for exemption shall include the following:

(1) The procurement specifications for the product or class of products that govern emissions of electronic product radiation.

(2) Evidence that the product or class of products is of a type used solely or predominantly by departments or agencies of the United States.

(3) Evidence that such product or class of products is intended for use by a department or agency of the United States.

(4) A description of the product or class of products and its intended use. (5) An explanation of how compliance with the applicable standard would restrict or be inappropriate for this intended use.

(6) A description of the manner in which it is proposed that the product or class of products shall deviate from the requirements of the applicable standard.

(7) An explanation of the advantages to be derived from such deviation.

(8) An explanation of how means of radiation protection will be provided where the product or class of products deviates from the requirements of the applicable standard.

(9) The period of time it is desired that the exemption be in effect, and, if appropriate, the number of units to be manufactured under the exemption.

(10) The name, address, and telephone number of the manufacturer or his agent.

(11) The name, address, and telephone number of the appropriate office of the United States department or agency purchasing the product or class of products.

(12) Such other information required by regulation or by the Director, Center for Devices and Radiological Health, to evaluate and act on the application. Where such information includes nonclinical laboratory studies, the information shall include, with respect to each nonclinical study, either a statement that each study was conducted in compliance with the requirements set forth in part 58 of this chapter, or, if the study was not conducted

in compliance with such regulations, a statement that describes in detail all differences between the practices used in the study and those required in the regulations. When such information includes clinical investigations involving human subjects, the information shall include, with respect to each clinical investigation, either a statement that each investigation was conducted in compliance with the requirements set forth in part 56 of this chapter, or a statement that the investigation is not subject to such requirements in accordance with § 56.104 or § 56.105 and a statement that each investigation was conducted in compliance with the requirements set forth in part 50 of this chapter.

(13) With respect to each nonclinical laboratory study contained in the application, either a statement that the study was conducted in compliance with the requirements set forth in part 58 of this chapter, or, if the study was not conducted in compliance with such regulations, a brief statement of the reason for the noncompliance.

(d) Amendment or extension of an exemption. An exemption is granted on the basis of the information contained in the orginal applicaion. Therefore, if changes are needed in the radiation safety specifications for the product, or its use, or related radiation control procedures such that the information in the original application would no longer be correct with respect to radiation safety, the applicant shall submit in advance of such changes a request for an amendment to the exemption. He also shall submit a request for extension of the exemption, if needed, at least 60 days before the expiration date. The application for amendment or extension of an exemption shall include the following information:

(1) The exemption number and expiration date.

(2) The amendment or extension requested and basis for the amendment or extension.

(3) If the radiation safety specifications for the product or class of products or the product's or class of products' use or related radiation control procedures differ from the description provided in the original application, a description of such changes.

(e) Ruling on an application. (1) The Director, Center for Devices and Radiological Health, may grant an exemption including in the written notice of exemption such conditions or terms as may be necessary to protect the public health and safety and shall notify the applicant in writing of his action. The conditions or terms of the exemption may include specifications concerning the manufacture, use, control, and disposal of the excess or surplus exempted product of class of products as provided in the Code of Federal Regulations, title 41, subtitle C. Each exemption will be assigned an identifying number. (2) The Director, Center for Devices and Radiological Health, shall amend or withdraw an exemption whenever he determines that such action is necessary to protect the public health or otherwise is justified by provisions of the act or this subchapter. Such action shall become effective on the date specified in the written notice of the action sent to the applicant, except that it shall become effective immediately when the Director determines that it is necessary to prevent an imminent health hazard.

(f) Identification of equipment covered by exemption. The manufacturer of any product for which an exemption is granted shall provide the following identification in the form of a tag or label permanently affixed or inscribed on such product so as to be legible and readily accessible to view when the product is fully assembled for use or in such other manner as may be prescribed in the exemption:

CAUTION

This electronic product has been exempted from Food and Drug Administration radiation safety performance standards prescribed in the Code of Federal Regulations, title 21, chapter I, subchapter J, pursuant to Exemption No. granted on

[42 FR 44229, Sept. 2, 1977; 42 FR 61257, Dec. 2, 1977, as amended at 44 FR 17657, Mar. 23, 1979; 46 FR 8460, 8958, Jan. 27, 1981; 50 FR 7518, Feb. 22, 1985; 50 FR 13564. Apr. 5, 1985; 53 FR 11254, Apr. 6, 1988; 59 FR 14365, Mar. 28, 1994]

Subpart B-Alternate Test Procedures

§ 1010.13 Special test procedures.

The Director, Center for Devices and Radiological Health, may, on the basis of a written application by a manufacturer, authorize test programs other than those set forth in the standards under this subchapter for an electronic product if he determines that such products are not susceptible to satisfactory testing by the procedures set forth in the standard and that the alternative test procedures assure compliance with the standard.

[40 FR 32257, July 31, 1975, as amended at 53 FR 11254, Apr. 6, 1988]

SOURCE: 38 FR 28632, Oct. 15, 1973, unless otherwise noted.

§ 1020.10 Television receivers.

(a) Applicability. The provisions of this section are applicable to television receivers manufactured subsequent to January 15, 1970.

(b) Definitions. (1) External surface means the cabinet or enclosure provided by the manufacturer as part of the receiver. If a cabinet or enclosure is not provided as part of the receiver, the external surface shall be considered to be a hypothetical cabinet, the plane surfaces of which are located at those minimum distances from the chassis sufficient to enclose all components of the receiver except that portion of the neck and socket of the cathode-ray tube which normally extends beyond the plane surfaces of the enclosure.

(2) Maximum test voltage means 130 root mean square volts if the receiver is designed to operate from nominal 110 to 120 root mean square volt power sources. If the receiver is designed to operate from a power source having some voltage other than from nominal 110 to 120 root mean square volts, maximum test voltage means 110 percent of the nominal root mean square voltage specified by the manufacturer for the power source.

(3) Service controls means all of those controls on a television receiver provided by the manufacturer for purposes of adjustment which, under normal usage, are not accessible to the user.

(4) Television receiver means an electronic product designed to receive and display a television picture through broadcast, cable, or closed circuit television.

(5) Usable picture means a picture in synchronization and transmitting

viewable intelligence.

(6) User controls means all of those controls on a television receiver, provided by the manufacturer for purposes of adjustment, which on a fully assembled receiver under normal usage, are accessible to the user.

(c) Requirements-(1) Exposure rate limit. Radiation exposure rates produced by a television receiver shall not exceed 0.5 milliroentgens per hour at a distance of five (5) centimeters from any point on the external surface of

the receiver, as measured in accordance with this section.

(2) Measurements. Compliance with the exposure rate limit defined in paragraph (c)(1) of this section shall be determined by measurements made with an instrument, the radiation sensitive volume of which shall have a cross section parallel to the external surface of the receiver with an area of ten (10) square centimeters and no dimension larger than five (5) centimeters. Measurements made with instruments having other areas must be corrected for spatial nonuniformity of the radiation field to obtain the exposure rate average over a ten (10) square centimeter

area.

(3) Test conditions. All measurements shall be made with the receiver displaying a usable picture and with the power source operated at supply voltages up to the maximum test voltage of the receiver and, as applicable, under the following specific conditions:

(i) On television receivers manufactured subsequent to January 15, 1970, measurements shall be made with all user controls adjusted so as to produce maximum x-radiation emissions from the receiver.

(ii) On television receivers manufactured subsequent to June 1, 1970, measurements shall be made with all user controls and all service controls adjusted to combinations which result in the production of maximum x-radiation emissions.

(iii) On television receivers manufactured subsequent to June 1, 1971, measurements shall be made under the conditions described in paragraph (c)(3) (ii) of this section, together with conditions identical to those which result from that component or circuit failure which maximizes x-radiation emissions.

(4) Critical component warning. The manufacturer shall permanently affix or inscribe a warning label, clearly legible under conditions of service, on all television receivers which could produce radiation exposure rates in excess of the requirements of this section as a result of failure or improper adjustment or improper replacement of a circuit or shield component. The warning label shall include the specification

of operating high voltage and an instruction for adjusting the high voltage to the specified value.

§ 1020.20 Cold-cathode gas discharge tubes.

(a) Applicability. The provisions of this section are applicable to coldcathode gas discharge tubes designed to demonstrate the effects of a flow of electrons or the production of x-radiation as specified herein.

(b) Definitions. Beam blocking device means a movable or removable portion of any enclosure around a cold-cathode gas discharge tube, which may be opened or closed to permit or prevent the emergence of an exit beam.

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.

Exit beam means that portion of the radiation which passes through the aperture resulting from the opening of the beam blocking device.

Exposure means the sum of the electrical charges on all of the ions of one sign produced in air when all electrons liberated by photons in a volume element of air are completely stopped in air divided by the mass of the air in the volume element. The special unit of exposure is the roentgen. One (1) roentgen equals 2.58×10-4 coulombs/kilogram.

(c) Requirements (1) Exposure rate limit. (i) Radiation exposure rates produced by cold-cathode gas discharge tubes shall not exceed 10 mR./hr. at a distance of thirty (30) centimeters from any point on the external surface of the tube, as measured in accordance with this section.

(ii) The divergence of the exit beam from tubes designed primarily to demonstrate the effects of x radiation, with the beam blocking device in the open position, shall not exceed (Pi) steradians.

(2) Measurements. (i) Compliance with the exposure rate limit defined in paragraph (c)(1)(i) of this section shall be determined by measurements averaged over an area of one hundred (100) square centimeters with no linear dimension greater than twenty (20) centimeters.

(ii) Measurements of exposure rates from tubes in enclosures from which the tubes cannot be removed without destroying the function of the tube may be made at a distance of thirty (30) centimeters from any point on the external surface of the enclosure, provided:

(a) In the case of enclosures containing tubes designed primarily to demonstrate the production of x radiation, measurements shall be made with any beam blocking device in the beam blocking position, or

(b) In the case of enclosures containing tubes designed primarily to demonstrate the effects of a flow of electrons, measurements shall be made with all movable or removable parts of such enclosure in the position which would maximize external exposure levels.

(3) Test conditions. (i) Measurements shall be made under the conditions of use specified in instructions provided by the manufacturer.

(ii) Measurements shall be made with the tube operated under forward and reverse polarity.

(4) Instructions, labels, and warnings. (i) Manufacturers shall provide, or cause to be provided, with each tube to which this section is applicable, appropriate safety instructions, together with instructions for the use of such tube, including the specification of a power source for use with the tube.

(ii) Each enclosure or tube shall have inscribed on or permanently affixed to it, tags or labels, which identify the intended polarity of the terminals and:

(a) In the case of tubes designed primarily to demonstrate the heat effect, fluorescence effect, or magnetic effect, a warning that application of power in excess of that specified may result in the production of x-rays in excess of allowable limits; and (b) in the case of tubes designed primarily to demonstrate the production of x-radiation, a warning that this device produces xrays when energized.

(iii) The tag or label required by this paragraph shall be located on the tube or enclosure so as to be readily visible and legible when the product is fully assembled for use.

§ 1020.30 Diagnostic x-ray systems and their major components.

(a) Applicability—(1) The provisions of this section are applicable to:

(i) The following components of diagnostic x-ray systems:

(A) Tube housing assemblies, x-ray controls, x-ray high-voltage generators, x-ray tables, cradles, film changers, vertical cassette holders mounted in a fixed location and cassette holders with front panels, and beam-limiting devices manufactured after August 1, 1974.

(B) Fluoroscopic imaging assemblies manufactured after August 1, 1974, and before April 26, 1977.

(C) Spot-film devices and image intensifiers manufactured after April 26, 1977.

(D) Cephalometric devices manufactured after February 25, 1978.

(E) Image receptor support devices for mammographic x-ray systems manufactured after September 5, 1978.

(ii) Diagnostic x-ray systems, except computed tomography x-ray systems, incorporating one or more of such components; however, such x-ray systems shall be required to comply only with those provisions of this section and §§ 1020.31 and 1020.32 which relate to the components certified in accordance with paragraph (c) of this section and installed into the systems.

(iii) Computed tomography (CT) xray systems manufactured before November 29, 1984.

(iv) CT gantries manufactured after September 3, 1985.

(2) The following provisions of this section and §1020.33 are applicable to CT x-ray systems manufactured or remanufactured on or after November 29,

(3) The provisions of this section and § 1020.33 in its entirety, including those provisions in paragraph (a)(2) of this section, are applicable to CT x-ray systems manufactured or remanufactured on or after September 3, 1985. The date of manufacture of the CT system is the date of manufacture of the CT gantry.

(b) Definitions. As used in this section and §§1020.31, 1020.32, and 1020.33, the following definitions apply:

Accessible surface means the external surface of the enclosure or housing provided by the manufacturer.

Accessory component means:

(1) A component used with diagnostic X-ray systems, such as a cradle or film changer, that is not necessary for the compliance of the system with applicable provisions of this subchapter but which requires an initial determination of compatibility with the system; or

(2) A component necessary for compliance of the system with applicable provisions of this subchapter but which may be interchanged with similar compatible components without affecting the system's compliance, such as one of a set of interchangeable beam-limiting devices; or

(3) A component compatible with all X-ray systems with which it may be used and that does not require compatibility or installation instructions, such as a tabletop cassette holder.

Aluminum equivalent means the thickness of aluminum (type 1100 alloy)1 affording the same attenuation, under specified conditions as the material in question.

Articulated joint means a joint between two separate sections of a tabletop which joint provides the capacity for one of the sections to pivot on the line segment along which the sections join.

Assembler means any person engaged in the business of assembling, replacing, or installing one or more components into a diagnostic x-ray system or subsystem. The term includes the owner of an x-ray system or his or her

1The nominal chemical composition of type 1100 aluminum alloy is 99.00 percent minimum aluminum, 0.12 percent copper, as given in "Aluminum Standards and Data" (1969). Copies may be obtained from: The Aluminum Association, New York, NY.