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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2014]
[CITE: 21CFR1000.15]
See Related Information on Examples of electronic products subject to the Radiation Control for Health and Safety Act of 1968. in CDRH databases



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER J--RADIOLOGICAL HEALTH

PART 1000 -- GENERAL

Subpart B--Statements of Policy and Interpretation

Sec. 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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