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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, 2013]
[CITE: 21CFR1020.20]
See Related Information on Cold-cathode gas discharge tubes. 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 1020 -- PERFORMANCE STANDARDS FOR IONIZING RADIATION EMITTING PRODUCTS

Sec. 1020.20 Cold-cathode gas discharge tubes.

(a)Applicability. The provisions of this section are applicable to cold-cathode 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*10-4coulombs/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 x-rays 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.

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