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21 CFR Part 1000 — General

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PART 1000—GENERAL Authority: 21 U.S.C. 360hh-360ss. Source: 38 FR 28624, Oct. 15, 1973, unless otherwise noted. Subpart A—General Provisions § 1000.1 General. References in this subchapter J to regulatory sections of the Code of Federal Regulations are to chapter I of title 21 unless otherwise noted. [50 FR 33688, Aug. 20, 1985] § 1000.3 Definitions. As used in this subchapter J: (a) Accidental radiation occurrence (b) Act (c) Chassis family (1) The same circuitry in the high voltage, horizontal oscillator, and power supply sections; (2) The same worst component failures; (3) The same type of high voltage hold-down or safety circuits; and (4) The same design and installation. (d) Commerce (1) Commerce between any place in any State and any place outside thereof, and (2) Commerce wholly within the District of Columbia. (e) Component, (f) Dealer (g) Director (h) Distributor (i) Electromagnetic radiation (j) Electronic product (1) Any manufactured or assembled product which, when in operation: (i) Contains or acts as part of an electronic circuit and (ii) Emits (or in the absence of effective shielding or other controls would emit) electronic product radiation, or (2) Any manufactured or assembled article 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 operation, emits (or in the absence of effective shielding or other controls would emit) such radiation. (k) Electronic product radiation (1) Any ionizing or nonionizing electromagnetic or particulate radiation, or (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. (l) Federal standard (m) Infrasonic, sonic (or audible) and ultrasonic waves (n) Manufacturer (o) Model (p) Model family (q) Modified model (r) Particulate radiation (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) Purchaser (t) State [60 FR 48380, Sept. 19, 1995; 61 FR 13422, Mar. 27, 1996, as amended at 88 FR 3652, Jan. 20, 2023] Subpart B—Statements of Policy and Interpretation § 1000.15 Examples of electronic products 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: Television receivers. Accelerators. X-ray machines (industrial, medical, research, educational). Particulate radiation and ionizing electromagnetic 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. Tanning and therapeutic lamps. Sanitizing and sterilizing devices. Black light sources. Welding equipment. Visible: White light devices. Infrared: Alarm systems. Diathermy units. Dryers, ovens, and heaters. Microwave: Alarm systems. Diathermy units. Dryers, ovens, and heaters. Medico-biological heaters. Microwave power generating devices. Radar devices. Remote control devices. Signal generators. Radio and low frequency: Cauterizers. Diathermy units. Power generation and transmission equipment. Signal generators. Electromedical equipment. (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: Communications transmitters. (d) Examples of electronic products which may emit infrasonic, sonic, and ultrasonic vibrations resulting from operation of an electronic circuit include: Infrasonic: Vibrators. Sonic: Electronic oscillators. Sound amplification equipment. Ultrasonic: Cauterizers. Cell and tissue disintegrators. Cleaners. Diagnostic and nondestructive testing equipment. Ranging and detection equipment.

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