PART 1040—PERFORMANCE STANDARDS FOR LIGHT-EMITTING PRODUCTS Authority: 21 U.S.C. 351, 352, 360, 360e-360j, 360hh-360ss, 371, 381. § 1040.10 Laser products. (a) Applicability. (1) Such a laser product is either sold to a manufacturer of an electronic product for use as a component (or replacement) in such electronic product, or (2) Sold by or for a manufacturer of an electronic product for use as a component (or replacement) in such electronic product, provided that such laser product: (i) Is accompanied by a general warning notice that adequate instructions for the safe installation of the laser product are provided in servicing information available from the complete laser product manufacturer under paragraph (h)(2)(ii) of this section, and should be followed, (ii) Is labeled with a statement that it is designated for use solely as a component of such electronic product and therefore does not comply with the appropriate requirements of this section and § 1040.11 for complete laser products, and (iii) Is not a removable laser system as described in paragraph (c)(2) of this section; and (3) The manufacturer of such a laser product, if manufactured after August 20, 1986: (i) Registers, and provides a listing by type of such laser products manufactured that includes the product name, model number, and laser medium or emitted wavelength(s), and the name and address of the manufacturer. The manufacturer must submit the registration and listing to the Director, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Silver Spring, MD 20993-0002. (ii) Maintains and allows access to any sales, shipping, or distribution records that identify the purchaser of such a laser product by name and address, the product by type, the number of units sold, and the date of sale (shipment). These records shall be maintained and made available as specified in § 1002.31. (b) Definitions. (1) Accessible emission level (2) Accessible emission limit (3) Aperture (4) Aperture stop (5) Class I laser product 1 1 (6) Class IIa laser product 2 2 3 3 (7) Class II laser product 3 3 (8) Class IIIa laser product 4 4 (9) Class IIIb laser product 5 5 (10) Class III laser product (11) Class IV laser product 6 6 (12) Collateral radiation (13) Demonstration laser product (14) Emission duration (15) Human access (16) Integrated radiance −2 −1 (17) Invisible radiation 6 (18) Irradiance −2 (19) Laser 6 (20) Laser energy source (21) Laser product (22) Laser radiation (23) Laser system (24) Maintenance (25) Maximum output (26) Medical laser product (27) Operation (28) Protective housing (29) Pulse duration (30) Radiance −2 −1 (31) Radiant energy (32) Radiant exposure −2 (33) Radiant power (34) Remote interlock connector (35) Safety interlock (36) Sampling interval t (37) Scanned laser radiation (38) Service (39) Surveying, leveling, or alignment laser product (i) Determining and delineating the form, extent, or position of a point, body, or area by taking angular measurement. (ii) Positioning or adjusting parts in proper relation to one another. (iii) Defining a plane, level, elevation, or straight line. (40) Visible radiation (41) Warning logotype (42) Wavelength (c) Classification of laser products All laser products. (2) Removable laser systems. (d) Accessible emission limits. k 1 k 2 Notes applicable to tables I, II-A, II, III-A and III-B: (1) The factors k 1 k 2 (2) The variable t (1) Beam of a single wavelength. (2) Beam of multiple wavelengths in same range. (3) Beam with multiple wavelengths in different ranges. (4) Class I dual limits. (i) The Class I accessible emission limits for radiant energy within any range of emission duration specified in table I of this paragraph, and (ii) The Class I accessible emission limits for integrated radiance within any range of emission duration specified in table I of this paragraph. (e) Tests for determination of compliance Tests for certification. (2) Test conditions. (i) Under those conditions and procedures which maximize the accessible emission levels, including start-up, stabilized emission, and shut-down of the laser product; and (ii) With all controls and adjustments listed in the operation, maintenance, and service instructions adjusted in combination to result in the maximum accessible emission level of radiation; and (iii) At points in space to which human access is possible in the product configuration which is necessary to determine compliance with each requirement, e.g., if operation may require removal of portions of the protective housing and defeat of safety interlocks, measurements shall be made at points accessible in that product configuration; and (iv) With the measuring instrument detector so positioned and so oriented with respect to the laser product as to result in the maximum detection of radiation by the instrument; and (v) For a laser product other than a laser system, with the laser coupled to that type of laser energy source which is specified as compatible by the laser product manufacturer and which produces the maximum emission level of accessible radiation from that product. (3) Measurement parameters. (i) For laser products intended to be used in a locale where the emitted laser radiation is unlikely to be viewed with optical instruments, the radiant power (W) or radiant energy (J) detectable through a circular aperture stop having a diameter of 7 millimeters and within a circular solid angle of acceptance of 1 × 10 −3 (ii) The irradiance (W cm −2 −2 −3 −2 (iii) The radiance (W cm −2 −1 −2 −1 −5 −2 (f) Performance requirements Protective housing. (2) Safety interlocks. (ii) Each required safety interlock, unless defeated, shall prevent such human access to laser and collateral radiation upon removal or displacement of such portion of the protective housing (iii) Either multiple safety interlocks or a means to preclude removal or displacement of the interlocked portion of the protective housing shall be provided, if failure of a single interlock would allow; ( a ( b (iv) Laser products that incorporate safety interlocks designed to allow safety interlock defeat shall incorporate a means of visual or aural indication of interlock defeat. During interlock defeat, such indication shall be visible or audible whenever the laser product is energized, with and without the associated portion of the protective housing removed or displaced. (v) Replacement of a removed or displaced portion of the protective housing shall not be possible while required safety interlocks are defeated. (3) Remote interlock connector. (4) Key control. (5) Laser radiation emission indicator. (ii) Each laser system classified as a Class IIIb or IV laser product shall incorporate an emission indicator which provides a visible or audible signal during emission of accessible laser radiation in excess of the accessible emission limits of Class I, and sufficiently prior to emission of such radiation to allow appropriate action to avoid exposure to the laser radiation. (iii) For laser systems manufactured on or before August 20, 1986, if the laser and laser energy source are housed separately and can be operated at a separation distance of greater than 2 meters, both laser and laser energy source shall incorporate an emission indicator as required in accordance with paragraph (f)(5) (i) or (ii) of this section. For laser systems manufactured after August 20, 1986, each separately housed laser and operation control of a laser system that regulates the laser or collateral radiation emitted by a product during operation shall incorporate an emission indicator as required in accordance with paragraph (f)(5) (i) or (ii) of this section, if the laser or operation control can be operated at a separation distance greater than 2 meters from any other separately housed portion of the laser product incorporating an emission indicator. (iv) Any visible signal required by paragraph (f)(5) (i) or (ii) of this section shall be clearly visible through protective eyewear designed specifically for the wavelength(s) of the emitted laser radiation. (v) Emission indicators required by paragraph (f)(5) (i) or (ii) of this section shall be located so that viewing does not require human exposure to laser or collateral radiation in excess of the accessible emission limits of Class I and table VI. (6) Beam attenuator. (ii) If the configuration, design, or function of the laser product would make unnecessary compliance with the requirement in paragraph (f)(6)(i) of this section, the Director, Center for Devices and Radiological Health, may, upon written application by the manufacturer, approve alternate means to accomplish the radiation protection provided by the beam attenuator. (7) Location of controls. (8) Viewing optics. (i) To prevent access by the human eye to laser and collateral radiation in excess of the accessible emission limits of Class I and table VI whenever the shutter is opened or the attenuator varied. (ii) To preclude, upon failure of such means as required in paragraph (f)(8)(i) of this section, opening the shutter or varying the attenuator when access by the human eye is possible to laser or collateral radiation in excess of the accessible emission limits of Class I and table VI. (9) Scanning safeguard. (i) The accessible emission limits of the class of the product, or (ii) The accessible emission limits of the class of the scanned laser radiation if the product is Class IIIb or IV and the accessible emission limits of Class IIIa would be exceeded solely as result of such failure. (10) Manual reset mechanism. (g) Labeling requirements. (1) Class IIa and II designations and warnings. (ii) Each Class II laser product shall have affixed a label bearing the warning logotype A (figure 1 in this paragraph) and including the following wording: [Position I on the logotype] “LASER RADIATION—DO NOT STARE INTO BEAM”; and [Position 3 on the logotype] “CLASS II LASER PRODUCT”. (2) Class IIIa and IIIb designations and warnings. −3 2− [Position 1 on the logotype] “LASER RADIATION—DO NOT STARE INTO BEAM OR VIEW DIRECTLY WITH OPTICAL INSTRUMENTS”; and, [Position 3 on the logotype] “CLASS IIIa LASER PRODUCT”. (ii) Each Class IIIa laser product with an irradiance greater than 2.5 × 10 −3 −2 [Position 1 on the logotype] “LASER RADIATION—AVOID DIRECT EYE EXPOSURE”; and, [Position 3 on the logotype] “CLASS IIIa LASER PRODUCT”. (iii) Each Class IIIb laser product shall have affixed a label bearing the warning logotype B (figure 2 of paragraph (g)(2)(ii) of this section) and including the following wording: [Position 1 on the logotype] “LASER RADIATION—AVOID DIRECT EXPOSURE TO BEAM”; and, [Position 3 on the logotype] “CLASS IIIb LASER PRODUCT”. (3) Class IV designation and warning. [Position 1 on the logotype] “LASER RADIATION—AVOID EYE OR SKIN EXPOSURE TO DIRECT OR SCATTERED RADIATION”; and, [Position 3 on the logotype] “CLASS IV LASER PRODUCT”. (4) Radiation output information on warning logotype. (5) Aperture label. (i) “AVOID EXPOSURE—Laser radiation is emitted from this aperture,” if the radiation emitted through such aperture is laser radiation. (ii) “AVOID EXPOSURE—Hazardous electromagnetic radiation is emitted from this aperture,” if the radiation emitted through such aperture is collateral radiation described in table VI, item 1. (iii) “AVOID EXPOSURE—Hazardous x-rays are emitted from this aperture,” if the radiation emitted through such aperture is collateral radiation described in table VI, item 2. (6) Labels for noninterlocked protective housings. (i) “CAUTION—Laser radiation when open. DO NOT STARE INTO BEAM.” for Class II accessible laser radiation. (ii) “CAUTION—Laser radiation when open. DO NOT STARE INTO BEAM OR VIEW DIRECTLY WITH OPTICAL INSTRUMENTS.” for Class IIIa accessible laser radiation with an irradiance less than or equal to 2.5 × 10 −3 −2. (iii) “DANGER—Laser radiation when open. AVOID DIRECT EYE EXPOSURE.” for Class IIIa accessible laser radiation with an irradiance greater than 2.5 × 10 −3 −2. (iv) “DANGER—Laser radiation when open. AVOID DIRECT EXPOSURE TO BEAM.” for Class IIIb accessible laser radiation. (v) “DANGER—Laser radiation when open. AVOID EYE OR SKIN EXPOSURE TO DIRECT OR SCATTERED RADIATION.” for Class IV accessible laser radiation. (vi) “CAUTION—Hazardous electromagnetic radiation when open.” for collateral radiation in excess of the accessible emission limits in table VI, item 1 of paragraph (d) of this section. (vii) “CAUTION—Hazardous x-rays when open.” for collateral radiation in excess of the accessible emission limits in table VI, item 2 of paragraph (d) of this section. (7) Labels for defeatably interlocked protective housings. (i) “CAUTION—Laser radiation when open and interlock defeated. DO NOT STARE INTO BEAM.” for Class II accessible laser radiation. (ii) “CAUTION—Laser radiation when open and interlock defeated. DO NOT STARE INTO BEAM OR VIEW DIRECTLY WITH OPTICAL INSTRUMENTS.” for Class IIIa accessible laser radiation with an irradiance less than or equal to 2.5 × 10 −3 −2. (iii) “DANGER—Laser radiation when open and interlock defeated. AVOID DIRECT EYE EXPOSURE.” for Class IIIa accessible laser radiation when an irradiance greater than 2.5 × 10 −3 −2. (iv) “DANGER—Laser radiation when open and interlock defeated. AVOID DIRECT EXPOSURE TO BEAM.” for Class IIIb accessible laser radiation. (v) “DANGER—Laser radiation when open and interlock defeated. AVOID EYE OR SKIN EXPOSURE TO DIRECT OR SCATTERED RADIATION.” for Clas IV accessible laser radiation. (vi) “CAUTION—Hazardous electromagnetic radiation when open and interlock defeated.” for collateral radiation in excess of the accessible emission limits in table VI. item 1 of paragraph (d) of this section. (vii) “CAUTION—Hazardous x-rays when open and interlock defeated.” for collateral radiation in excess of the accesible emission limits in table VI. item 2 of paragraph (d) of this section. (8) Warning for visible and/or invisible radiation. (i) Invisible radiation, the word “invisible” shall appropriately precede the word “radiation”; or (ii) Visible and invisible radiation, the words “visible and invisible” or “visible and/or invisible” shall appropriately precede the word “radiation.” (iii) Visible laser radiation only, the phrase “laser light” may replace the phrase “laser radiation.” (9) Positioning of labels. (10) Label specifications. (h) Informational requirements User information. (i) Adequate instructions for assembly, operation, and maintenance, including clear warnings concerning precautions to avoid possible exposure to laser and collateral radiation in excess of the accessible emission limits in tables I, II-A, II, III-A, III-B, and VI of paragraph (d) of this section, and a schedule of maintenance necessary to keep the product in compliance with this section and § 1040.11. (ii) A statement of the magnitude, in appropriate units, of the pulse durations(s), maximum radiant power and, where applicable, the maximum radiant energy per pulse of the accessible laser radiation detectable in each direction in excess of the accessible emission limits in table I of paragraph (d) of this section determined under paragraph (e) of this section. (iii) Legible reproductions (color optional) of all labels and hazard warnings required by paragraph (g) of this section and § 1040.11 to be affixed to the laser product or provided with the laser product, including the information required for positions 1, 2, and 3 of the applicable logotype (figure 1 of paragraph (g)(1)(ii) or figure 2 or paragraph (g)(2)(ii) of this section). The corresponding position of each label affixed to the product shall be indicated or, if provided with the product, a statement that such labels could not be affixed to the product but were supplied with the product and a statement of the form and manner in which they were supplied shall be provided. (iv) A listing of all controls, adjustments, and procedures for operation and maintenance, including the warning “Caution—use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous radiation exposure.” (v) In the case of laser products other than laser systems, a statment of the compatibility requirements for a laser energy source that will assure compliance of the laser product with this section and § 1040.11. (vi) In the case of laser products classified with a 7 millimeter diameter aperture stop as provided in paragraph (e)(3)(i) of this section, if the use of a 50 millimeter diameter aperture stop would result in a higher classification of the product, the following warning shall be included in the user information: “CAUTION—The use of optical instruments with this product will increase eye hazard.” (2) Purchasing and servicing information. (i) In all catalogs, specification sheets, and descriptive brochures pertaining to each laser product, a legible reproduction (color optional) of the class designation and warning required by paragraph (g) of this section to be affixed to that product, including the information required for positions 1, 2, and 3 of the applicable logotype (figure 1 of paragraph (g)(1)(ii) or figure 2 of paragraph (g)(2)(ii) of this section). (ii) To servicing dealers and distributors and to others upon request at a cost not to exceed the cost of preparation and distribution, adequate instructions for service adjustments and service procedures for each laser product model, including clear warnings and precautions to be taken to avoid possible exposure to laser and collateral radiation in excess of the accessible emission limits in tables I, II-A, II, III-A, III-B, and VI of paragraph (d) of this section, and a schedule of maintenance necessary to keep the product in compliance with this section and § 1040.11; and in all such service instructions, a listing of those controls and procedures that could be utilized by persons other than the manufacturers or the manufacturer's agents to increase accessible emission levels of radiation and a clear description of the location of displaceable portions of the protective housing that could allow human access to laser or collateral radiation in excess of the accessible emission limits in tables I, II-A, II, III-A, III-B, and VI of paragraph (d) of this section. The instructions shall include protective procedures for service personnel to avoid exposure to levels of laser and collateral radiation known to be hazardous for each procedure or sequence of procedures to be accomplished, and legible reproductions (color optional) of required labels and hazard warnings. (i) Modification of a certified product. (The information collection requirements contained in paragraph (a)(3)(ii) were approved by the Office of Management and Budget under control number 0910-0176) [50 FR 33688, Aug. 20, 1985; 50 FR 42156, Oct. 18, 1985; 65 FR 17138, Mar. 31, 2000, as amended at 75 FR 20917, Apr. 22, 2010; 83 FR 13864, Apr. 2, 2018] § 1040.11 Specific purpose laser products. (a) Medical laser products. (1) Incorporate in each Class III or IV medical laser product a means for the measurement of the level of that laser radiation intended for irradiation of the human body. Such means may have an error in measurement of no more than 20 percent when calibrated in accordance with paragraph (a)(2) of this section. Indication of the measurement shall be in International System Units. The requirements of this paragraph do not apply to any laser radiation that is all of the following: (i) Of a level less than the accessible limits of Class IIIa; and (ii) Used for relative positioning of the human body; and (iii) Not used for irradiation of the human eye for ophthalmic purposes. (2) Supply with each Class III or IV medical laser product instructions specifying a procedure and schedule for calibration of the measurement system required by paragraph (a)(1) of this section. (3) Affix to each medical laser product, in close proximity to each aperture through which is emitted accessible laser radiation in excess of the accessible emission limits of Class I, a label bearing the wording: “Laser aperture.” (b) Surveying, leveling, and alignment laser products. (c) Demonstration laser products. [50 FR 33702, Aug. 20, 1985] § 1040.20 Sunlamp products and ultraviolet lamps intended for use in sunlamp products. (a) Applicability. (i) Any sunlamp product. (ii) Any ultraviolet lamp intended for use in any sunlamp product. (2) Sunlamp products and ultraviolet lamps manufactured on or after May 7, 1980, but before September 8, 1986, are subject to the provisions of this section as published in the Federal Register (b) Definitions. (1) Exposure position (2) Intended (3) Irradiance 2 (4) Maximum exposure time (5) Maximum timer interval (6) Protective eyewear (7) Spectral irradiance 2 (8) Spectral transmittance (9) Sunlamp product (10) Timer (11) Ultraviolet lamp (c) Performance requirements Irradiance ratio limits. (2) Timer system. (ii) The maximum timer interval(s) may not exceed the manufacturer's recommended maximum exposure time(s) that is indicated on the label required by paragraph (d)(1)(iv) of this section. (iii) No timer interval may have an error greater than 10 percent of the maximum timer interval of the product. (iv) The timer may not automatically reset and cause radiation emission to resume for a period greater than the unused portion of the timer cycle, when emission from the sunlamp product has been terminated. (v) The timer requirements do not preclude a product from allowing a user to reset the timer before the end of the preset time interval. (3) Control for termination of radiation emission. (4) Protective eyewear. (ii) The spectral transmittance to the eye of the protective eyewear required by paragraph (c)(4)(i) of this section shall not exceed a value of 0.001 over the wavelength range of greater than 200 nanometers 320 nanometers and a value of 0.01 over the wavelength range of greater than 320 nanometers through 400 nanometers, and shall be sufficient over the wavelength greater than 400 nanometers to enable the user to see clearly enough to reset the timer. (5) Compatibility of lamps. http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. (d) Label requirements. (1) Labels for sunlamp products. (i) A warning statement with the words “DANGER—Ultraviolet radiation. Follow instructions. Avoid overexposure. As with natural sunlight, overexposure can cause eye and skin injury and allergic reactions. Repeated exposure may cause premature aging of the skin and skin cancer. WEAR PROTECTIVE EYEWEAR; FAILURE TO MAY RESULT IN SEVERE BURNS OR LONG-TERM INJURY TO THE EYES. Medications or cosmetics may increase your sensitivity to the ultraviolet radiation. Consult physician before using sunlamp if you are using medications or have a history of skin problems or believe yourself especially sensitive to sunlight. If you do not tan in the sun, you are unlikely to tan from the use of this product.” (ii) Recommended exposure position(s). Any exposure position may be expressed either in terms of a distance specified both in meters and in feet (or in inches) or through the use of markings or other means to indicate clearly the recommended exposure position. (iii) Directions for achieving the recommended exposure position(s) and a warning that the use of other positions may result in overexposure. (iv) A recommended exposure schedule including duration and spacing of sequential exposures and maximum exposure time(s) in minutes. (v) A statement of the time it may take before the expected results appear. (vi) Designation of the ultraviolet lamp type to be used in the product. (2) Labels for ultraviolet lamps. (i) The words “Sunlamp—DANGER—Ultraviolet radiation. Follow instructions.” (ii) The model identification. (iii) The words “Use ONLY in fixture equipped with a timer.” (3) Label specifications. (ii) Any label prescribed in this paragraph for ultraviolet lamps shall be permanently affixed or inscribed on the product so as to be legible and readily accessible to view. (iii) If the size, configuration, design, or function of the sunlamp product or ultraviolet lamp would preclude compliance with the requirements for any required label or would render the required wording of such label inappropriate or ineffective, or would render the required label unnecessary, the Director, Center for Devices and Radiological Health, on the center's own initiative or upon written application by the manufacturer, may approve alternate means of providing such label(s), alternate wording for such label(s), or deletion, as applicable. (iv) In lieu of permanently affixing or inscribing tags or labels on the ultraviolet lamp as required by §§ 1010.2(b) and 1010.3(a), the manufacturer of the ultraviolet lamp may permanently affix or inscribe such required tags or labels on the lamp packaging uniquely associated with the lamp, if the name of the manufacturer and month and year of manufacture are permanently affixed or inscribed on the exterior surface of the ultraviolet lamp so as to be legible and readily accessible to view. The name of the manufacturer and month and year of manufacture affixed or inscribed on the exterior surface of the lamp may be expressed in code or symbols, if the manufacturer has previously supplied the Director, Center for Devices and Radiological Health, with the key to such code or symbols and the location of the coded information or symbols on the ultraviolet lamp. The label or tag affixed or inscribed on the lamp packaging may provide either the month and year of manufacture without abbreviation, or information to allow the date to be readily decoded. (v) A label may contain statements or illustrations in addition to those required by this paragraph if the additional statements are not false or misleading in any particular; e.g., if they do not diminish the impact of the required statements; and are not prohibited by this chapter. (e) Instructions to be provided to users. (1) Sunlamp products. (i) A reproduction of the label(s) required in paragraph (d)(1) of this section prominently displayed at the beginning of the instructions. (ii) A statement of the maximum number of people who may be exposed to the product at the same time and a warning that only that number of protective eyewear has been provided. (iii) Instructions for the proper operation of the product including the function, use, and setting of the timer and other controls, and the use of protective eyewear. (iv) Instructions for determining the correct exposure time and schedule for persons according to skin type. (v) Instructions for obtaining repairs and recommended replacement components and accessories which are compatible with the product, including compatible protective eyewear, ultraviolet lamps, timers, reflectors, and filters, and which will, if installed or used as instructed, result in continued compliance with the standard. (2) Ultraviolet lamps. (i) A reproduction of the label(s) required in paragraphs (d)(1)(i) and (2) of this section, prominently displayed at the beginning of the instructions. (ii) A warning that the instructions accompanying the sunlamp product should always be followed to avoid or to minimize potential injury. (iii) A clear identification by brand and model designation of all lamp models for which replacement lamps are promoted, if applicable. (f) Test for determination of compliance. [50 FR 36550, Sept. 6, 1985, as amended at 67 FR 9587, Mar. 4, 2002; 69 FR 18803, Apr. 9, 2004; 75 FR 20917, Apr. 22, 2010; 83 FR 13865, Apr. 2, 2018] § 1040.30 High-intensity mercury vapor discharge lamps. (a) Applicability. (b) Definitions. High-intensity mercury vapor discharge lamp (2) Advertisement (3) Packaging (4) Outer envelope (5) Shortwave ultraviolet radiation (6) Cumulative operating time (7) Self-extinguishing lamp (8) Reference ballast 1 1 (c) General requirements for all lamps. (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 Maximum cumulative operating time. (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. (3) Lamp packaging. (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 Lamp labeling. (2) Lamp packaging. (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. (f) Test conditions. (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]