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]
Title 21 CFR reference
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United States • Title 21 CFR • Part 1000
Part 1000 — PART 1000—GENERAL
Part 1000 of Title 21 CFR outlines general provisions for the Food and Drug Administration's radiological health regulations. It includes definitions for key terms related to electronic products and radiation, and provides examples of products subject to the Radiation Control for Health and Safety Act of 1968.
What this part covers
- Establishes general rules and definitions for radiological health regulations under Subchapter J.
- Defines terms such as 'electronic product,' 'electronic product radiation,' 'manufacturer,' and 'purchaser.'
- References the Federal Food, Drug, and Cosmetic Act as the basis for these regulations.
- Provides illustrative examples of electronic products that are sources of electronic product radiation, categorized by the type of radiation emitted (e.g., X-rays, UV, microwaves, sonic waves).
- References other sections of the Code of Federal Regulations within this subchapter.
Sections in Part 1000
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: (b) Examples of electronic products which may emit ultraviolet, visible, infrared, microwaves, radio and low frequency electromagnetic radiation include: (c) Examples of electronic products which may emit coherent electromagnetic radiation produced by stimulated emission include: (d) Examples of electronic products which may emit infrasonic, sonic, and ultrasonic vibrations resulting from operation of an electronic circuit include: Ultraviolet: Laser: Infrasonic:
Definitions.
As used in this subchapter J: Accidental radiation occurrence(a) means a single accidental event or series of accidental 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. Act(b) means the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360hh-360ss). Chassis family(c) 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. Commerce(d) means: (1) Commerce between any place in any State and any place outside thereof, and (2) Commerce wholly within the District of Columbia. Component,(e) 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. Dealer(f) means a person engaged in the business of…
Regulatory Context
This document sits within United States CFR and is most useful when linked to operational submission, quality, and inspection workflows.
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