[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1000.3]

[Page 559-561]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 1000--GENERAL--Table of Contents
 
                      Subpart A--General Provisions
 
Sec. 1000.3  Definitions.

    As used in this subchapter J:
    (a) Accidental radiation occurrence means a single event or series 
of events that has/have resulted in injurious or potentially injurious 
exposure of any person to electronic product radiation as a result of 
the manufacturing, testing, or use of an electronic product.
    (b) Act means the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360hh-360ss).
    (c) Chassis family means a group of one or more models with all of 
the following common characteristics:
    (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 means:
    (1) Commerce between any place in any State and any place outside 
thereof, and
    (2) Commerce wholly within the District of Columbia.
    (e) Component, for the purposes of this part, means an essential 
functional part of a subassembly or of an assembled electronic product, 
and which may affect the quantity, quality, direction, or radiation 
emission of the finished product.
    (f) Dealer means a person engaged in the business of offering 
electronic products for sale to purchasers, without regard to whether 
such person is or has been primarily engaged in such business, and 
includes persons who offer such products for lease or as prizes or 
awards.
    (g) Director means the Director of the Center for Devices and 
Radiological Health.
    (h) Distributor means a person engaged in the business of offering 
electronic products for sale to dealers, without regard to whether such 
person is or has been primarily or customarily engaged in such business.
    (i) Electromagnetic radiation includes the entire electromagnetic 
spectrum of radiation of any wavelength. The electromagnetic spectrum 
illustrated in figure 1 includes, but is not limited to, gamma rays, x-
rays, ultra-violet, visible, infrared, microwave, radiowave, and low 
frequency radiation.

[[Page 560]]

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    (j) Electronic product means:
    (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 means:
    (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 means a performance standard issued pursuant to 
section 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.
    (o) 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.

[[Page 561]]

    (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.

[60 FR 48380, Sept. 19, 1995; 61 FR 13422, Mar. 27, 1996]