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. The users' instructions for an ultraviolet lamp not accompanying a sunlamp product shall contain:

(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. Tests on which certification pursuant to § 1010.2 is based shall account for all errors and statistical uncertainties in the process and, wherever applicable, for changes in radiation emission or degradation in radiation safety with age of the product. Measurements for certification purposes shall be made under those operational conditions, lamp voltage, current, and position as recommended by the manufacturer. For these measurements, the measuring instrument shall be positioned at the recommended exposure position and so oriented as to result in the maximum detection of the radiation by the instrument.

(The information collection requirements contained in paragraphs (d) and (e) were approved by the Office of Management and Budget under control number 0910-0195) [50 FR 36550, Sept. 6, 1985]

ception of the tungsten filament selfballasted 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 highpressure 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 C82.51977)1 or its equivalent.

(c) General requirements for all lamps. (1) Each high-intensity mercury vapor discharge lamp shall:

(1) Meet the requirements of either paragraph (d) or paragraph (e) of this section; and

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 selfextinguish 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 2515 °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]

§ 1050.10 Ultrasonic therapy products.

(a) Applicability. The provisions of this section are applicable as specified herein to any ultrasonic therapy product for use in physical therapy manufactured on or after February 17, 1979.

(b) Definitions. The following definitions apply to words and phrases used in this section:

(1) Amplitude modulated waveform means a waveform in which the ratio of the temporal-maximum pressure amplitude spatially averaged over the effective radiating surface to the rootmean-square pressure amplitude spatially averaged over the effective radiating surface is greater than 1.05.

(2) Applicator means that portion of a fully assembled ultrasonic therapy product that is designed to emit ultrasonic radiation and which includes one or more ultrasonic transducers and any associated housing.

(3) Beam cross-section means the surface in any plane consisting of the points at which the intensity is greater than 5 percent of the spatial-maximum intensity in that plane.

(4) Beam nonuniformity ratio means the ratio of the temporal-average spatial-maximum intensity to the temporal-average effective intensity.

(5) Centroid of a surface means the point whose coordinates are the mean

values of the coordinates of the points of the surface.

(6) Collimating applicator means an applicator that does not meet the definition of a focusing applicator as specified in paragraph (b)(15) of this section and for which the ratio of the area of at least one beam cross-section, whose centroid is 12 centimeters from the centroid of the effective radiating surface, to the area of the effective radiating surface is less than two.

(7) Continuous-wave waveform means a waveform in which the ratio of the temporal-maximum pressure amplitude spatially averaged over the effective radiating surface to the root-meansquare pressure amplitude spatially averaged over the effective radiating surface is less than or equal to 1.05.

(8) Diverging applicator means an applicator that does not meet the definition of a collimating applicator or a focusing applicator as specified in paragraphs (b) (6) and (15) of this section.

(9) Effective intensity means the ratio of the ultrasonic power to the focal area for a focusing applicator. For all other applicators, the effective intensity is the ratio of the ultrasonic power to the effective radiating area. Effective intensity is expressed in watts per square centimeter (W cm-2).

(10) Effective radiating area means the area consisting of all points of the effective radiating surface at which the intensity is 5 percent or more of the maximum intensity at the effective radiating surface, expressed in square centimeters (cm2).

(11) Effective radiating surface means the surface consisting of all points 5 millimeters from the applicator face.

(12) Focal area means the area of the focal surface, expressed in square centimeters (cm2).

(13) Focal length means the distance between the centroids of the effective radiating surface and the focal surface, for a focusing applicator, expressed in centimeters (cm).

(14) Focal surface means the beam cross-section with smallest area of a focusing applicator.

(15) Focusing applicator means an applicator in which the ratio of the area of the beam cross-section with the smallest area to the effective radiating area is less than one-half.

(16) Generator means that portion of a fully assembled ultrasonic therapy product that supplies electrical energy to the applicator. The generator may include, but is not limited to, a power supply, ultrasonic frequency oscillator, service controls, operation controls, and a cabinet to house these components.

(17) Maximum beam nonuniformity ratio means the maximum value of the beam nonuniformity ratio characteristic of a model of an ultrasonic therapy product.

(18) Operation control means any control used during operation of an ultrasonic therapy product that affects the ultrasonic radiation emitted by the applicator.

(19) Pressure amplitude means the instantaneous value of the modulating waveform, and is p1(t) in the expression for a pressure wave, p(t)=p1(t) p2(t), where p(t) is the instantaneous pressure, pi(t) is the modulating envelope, and p2(t) is the relative amplitude of the carrier wave normalized to a peak height of one. All are periodic functions of time, t, at any point in space. The period of pi(t) is greater than the period of p2(t).

(20) Pulse duration means a time interval, expressed in seconds, beginning at the first time the pressure amplitude exceeds the minimum pressure amplitude plus 10 percent of the difference between the maximum and minimum pressure amplitudes, ending at the last time the pressure amplitude returns to this value.

and

(21) Pulse repetition rate means the repetition frequency of the waveform modulating the ultrasonic carrier wave expressed in pulses per second (pps).

(22) Service control means any control provided for the purpose of adjustment that is not used during operation and can affect the ultrasonic radiation emitted by the applicator, or can alter the calibration or accuracy of an indicator or operation control.

(23) Ultrasonic frequency means the frequency of the ultrasonic radiation carrier wave, expressed in Hertz (Hz), kilohertz (kHz), or megahertz (MHz).

(24) Ultrasonic power means the total power emitted in the form of ultrasonic radiation by the applicator averaged

over each cycle of the ultrasonic radiation carrier wave, expressed in watts.

(25) Ultrasonic therapy product means:

(i) Any device intended to generate and emit ultrasonic radiation for therapeutic purposes at ultrasonic frequencies above 16 kilohertz (kHz); or

(ii) Any generator or applicator designed or specifically designated for use in a device as specified in paragraph (b)(25)(i) of this section.

(26) Ultrasonic transducer means a device used to convert electrical energy of ultrasonic frequency into ultrasonic radiation or vice versa.

(c) Performance requirements. The requirements of this paragraph are applicable to each ultrasonic therapy product as defined in paragraph (b)(25) of this section when the generator and applicator are designated or intended for use together, or to each generator when the applicator(s) intended for use with the generator does not contain controls that affect the functioning of the generator.

(1) Ultrasonic power and intensity-(i) Continuous-wave waveform operation. A means shall be incorporated to indicate the magnitudes of the temporal-average ultrasonic power and the temporalaverage effective intensity when emission is of continuous-wave waveform. The error in the indication of the temporal-average ultrasonic power shall not exceed ±20 percent for all emissions greater than 10 percent of the maximum emission.

(ii) Amplitude-modulated waveform operation. A means shall be incorpor-ated to indicate the magnitudes of the temporal-maximum ultrasonic power and the temporal-maximum effective intensity when the emission is of amplitudemodulated waveform. The sum of the errors in the indications of the temporal-maximum ultrasonic power and the ratio of the temporal-maximum effective intensity to the temporal-average effective intensity specified in paragraph (d)(3)(ii) of this section shall not exceed ±20 percent for all emissions greater than 10 percent of the maximum emission.

(2) Treatment time. A means shall be incorporated to enable the duration of emission of ultrasonic radiation for treatment to be preset and such means shall terminate emission at the end of

the preset time. Means shall also be incorporated to enable termination of emission at any time. Means shall be incorporated to indicate the magnitude of the duration of emission (expressed in minutes) to within 0.5 minute of the preset duration of emission for setting less than 5 minutes, to within 10 percent of the preset duration of emission for settings of from 5 minutes to 10 minutes, and to within 1 minute of the preset duration of emission for settings greater than 10 minutes.

(3) Pulse duration and repetition rate. A means shall be incorporated for indicating the magnitudes of pulse duration and pulse repetition rate of the emitted ultrasonic radiation, if there are operation controls for varying these quantities.

(4) Ultrasonic frequency. A means shall be incorporated for indicating the magnitude of the ultrasonic frequency of the emitted ultrasonic radiation, if there is an operation control for varying this quantity.

(5) Visual indicator. A means shall be incorporated to provide a clear, distinct, and readily understood visual indicator when and only when electrical energy of appropriate ultrasonic frequency is being applied to the ultrasonic transducer(s).

(d) Labeling requirements. In addition to the labeling requirements in part 801 and the requirements of §§ 1010.2 and 1010.3 of this chapter, each ultrasonic therapy product shall be subject to the applicable labeling requirements of this paragraph.

(1) Operation controls. Each operation control shall be clearly labeled identifying the function controlled and, where appropriate, the units of measure of that function. If a separate control and indicator are associated with the same function, then labeling the appropriate units of measure of that function is required for the indicator but not for the control.

(2) Service controls. Each service control that is accessible without displacement or removal of any part of the ultrasonic therapy product shall be clearly labeled identifying the function controlled and shall include the phrase "for service adjustment only."

(3) Generators. (i) Each generator shall bear a label that states: The

brand name, model designation, and unique serial number or other unique identification so that it is individually identifiable; ultrasonic frequency (unless there is an operation control for varying this quantity); and type of waveform (continuous wave or amplitude modulated).

(ii) Generators employing amplitudemodulated waveforms shall also bear a label that provides the following information: Pulse duration and pulse repetition rate (unless there are operation controls for varying these quantities), an illustration of the amplitude-modulated waveform, and the ratio of the temporal-maximum effective intensity to the temporal-average effective intensity. (If this ratio is a function of any operation control setting, then the range of the ratio shall be specified, and the waveform illustration shall be provided for the maximum value of this ratio.)

(4) Applicators. Each applicator shall bear a label that provides the following information:

(i) The brand name, model designation, and unique serial number or other unique identification so the applicator is individually identifiable;

(ii) A designation of the generator(s) for which the applicator is intended; and

(iii) The ultrasonic frequency, effective radiating area, maximum beam nonuniformity ratio, type of applicator (focusing, collimating, diverging), and for a focusing applicator the focal length and focal area.

(5) Label specification. Labels required by this paragraph shall be permanently affixed to or inscribed on the ultrasonic therapy product; they shall be legible and clearly visible. If the size, configuration, or design of the ultrasonic therapy product would preclude compliance with the requirements of this paragraph, the Director, Center for Devices and Radiological Health, may approve alternate means of providing such labels).

(e) Tests for determination of compliance (1) Tests for certification. Tests on which certification pursuant to §1010.2 of this chapter is based shall account for all measurement errors and uncertainties. Such tests shall also account