Code of Federal Regulations (Last Updated: November 8, 2024) |
Title 21 - Food and Drugs |
Chapter I - Food and Drug Administration, Department of Health and Human Services |
SubChapter J - Radiological Health |
Part 1040 - Performance Standards for Light-Emitting Products |
§ 1040.30 - High-intensity mercury vapor discharge lamps.
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§ 1040.30 High-intensity mercury vapor discharge lamps.
(a) Applicability. The provisions of this section apply to any high-intensity mercury vapor discharge lamp that is designed, intended, or promoted for illumination purposes and is manufactured or assembled after March 7, 1980, except as described in paragraph (d)(1)(ii) of this section.
(b) Definitions.
(1) High-intensity mercury vapor discharge lamp means any lamp including any “mercury vapor” and “metal halide” lamp, with the exception of the tungsten filament self-ballasted mercury vapor lamp, incorporating a high-pressure arc discharge tube that has a fill consisting primarily of mercury and that is contained within an outer envelope.
(2) Advertisement means any catalog, specification sheet, price list, and any other descriptive or commercial brochure and literature, including videotape and film, pertaining to high-intensity mercury vapor discharge lamps.
(3) Packaging means any lamp carton, outer wrapping, or other means of containment that is intended for the storage, shipment, or display of a high-intensity mercury vapor lamp and is intended to identify the contents or recommend its use.
(4) Outer envelope means the lamp element, usually glass, surrounding a high-pressure arc discharge tube, that, when intact, attenuates the emission of shortwave ultraviolet radiation.
(5) Shortwave ultraviolet radiation means ultraviolet radiation with wavelengths shorter than 320 nanometers.
(6) Cumulative operating time means the sum of the times during which electric current passes through the high-pressure arc discharge.
(7) Self-extinguishing lamp means a high-intensity mercury vapor discharge lamp that is intended to comply with the requirements of paragraph (d)(1) of this section as applicable.
(8) Reference ballast is an inductive reactor designed to have the operating characteristics as listed in Section 7 in the American National Standard Specifications for High-Intensity Discharge Lamp Reference Ballasts (ANSI C82.5-1977)[1] /> or its equivalent.
(c) General requirements for all lamps.
(1) Each high-intensity mercury vapor discharge lamp shall:
(i) Meet the requirements of either paragraph (d) or paragraph (e) of this section; and
(ii) Be permanently labeled or marked in such a manner that the name of the manufacturer and the month and year of manufacture of the lamp can be determined on an intact lamp and after the outer envelope of the lamp is broken or removed. The name of the manufacturer and month and year of manufacture may be expressed in code or symbols, provided the manufacturer has previously supplied the Director, Center for Devices and Radiological Health, with the key to the code or symbols and the location of the coded information or symbols on the lamp.
(2) In lieu of permanently affixing or inscribing tags or labels on the product as required by §§ 1010.2(b) and 1010.3(a) of this chapter, the manufacturer of any high-intensity mercury vapor discharge lamp may permanently affix or inscribe such required tags or labels on the lamp packaging uniquely associated with the applicable lamp.
(d) Requirements for self-extinguishing lamps -
(1) Maximum cumulative operating time.
(i) Each self-extinguishing lamp manufactured after March 7, 1980 shall cease operation within a cumulative operating time not to exceed 15 minutes following complete breakage or removal of the outer envelope (with the exception of fragments extending 50 millimeters or less from the base shell); and
(ii) Each self-extinguishing lamp manufactured after September 7, 1981, shall cease operation within a cumulative operating time not to exceed 15 minutes following breakage or removal of at least 3 square centimeters of contiguous surface of the outer envelope.
(2) Lamp labeling. Each self-extinguishing lamp shall be clearly marked with the letter “T” on the outer envelope and on another part of the lamp in such a manner that it is visible after the outer envelope of the lamp is broken or removed.
(3) Lamp packaging. Lamp packaging for each self-extinguishing lamp shall clearly and prominently display:
(i) The letter “T”; and
(ii) The words “This lamp should self-extinguish within 15 minutes after the outer envelope is broken or punctured. If such damage occurs, TURN OFF AND REMOVE LAMP to avoid possible injury from hazardous shortwave ultraviolet radiation.”
(e) Requirements for lamps that are not self-extinguishing lamps -
(1) Lamp labeling. Any high-intensity mercury vapor discharge lamp that does not comply with paragraph (d)(1) of this section shall be clearly and legibly marked with the letter “R” on the outer envelope and on another part of the lamp in such a manner that it is visible after the outer envelope of the lamp is broken or removed.
(2) Lamp packaging. Lamp packaging for each high-intensity mercury vapor discharge lamp that does not comply with paragraph (d)(1) of this section shall clearly and prominently display:
(i) The letter “R”; and
(ii) The words “WARNING: This lamp can cause serious skin burn and eye inflammation from shortwave ultraviolet radiation if outer envelope of the lamp is broken or punctured. Do not use where people will remain for more than a few minutes unless adequate shielding or other safety precautions are used. Lamps that will automatically extinguish when the outer envelope is broken or punctured are commercially available.”
(3) Lamp advertisement. Advertising for any high-intensity mercury vapor discharge lamp that does not comply with paragraph (d)(1) of this section shall prominently display the following wording: “WARNING: This lamp can cause serious skin burn and eye inflammation from shortwave ultraviolet radiation if outer envelope of the lamp is broken or punctured. Do not use where people will remain for more than a few minutes unless adequate shielding or other safety precautions are used. Lamps that will automatically extinguish when the outer envelope is broken or punctured are commercially available.”
(f) Test conditions. Any high-intensity mercury vapor discharge lamp under test for compliance with the requirements set forth in paragraph (d)(1) of this section shall be started and operated under the following conditions as applicable:
(1) Lamp voltage, current, and orientation shall be those indicated or recommended by the manufacturer for operation of the intact lamp.
(2) The lamp shall be operated on a reference ballast.
(3) The lamp shall be started in air that has a temperature of 25 ±5 °C. Heating and movement of the air surrounding the lamp shall be that produced by the lamp and ballast alone.
(4) If any test is performed in an enclosure, the enclosure shall be not less than 0.227 cubic meter (8 cubic feet).
(5) Any lamp designed to be operated only in a specific fixture or luminaire that the lamp manufacturer supplies or specifies shall be tested in that fixture or luminaire. Any other lamp shall be tested with no reflector or other surrounding material.
[44 FR 52195, Sept. 7, 1979, as amended at 53 FR 11254, Apr. 6, 1988]