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. Each ultraviolet lamp shall have a label which contains:

(i) The words "Sunlamp-DANGERUltraviolet radiation. Follow instructions."

(ii) The model identification.

(iii) The words "Use ONLY in fixture equipped with a timer."

(3) Label specifications. (i) Any label prescribed in this paragraph for sunlamp products shall be permanently affixed or inscribed on an exterior surface of the product when fully assembled for use so as to be legible and readily accessible to view by the person being exposed immediately before the use of the product.

(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, Office of Compliance (HFZ-300), 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), alernate 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 manfacturer 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, Office of Compliance (HFZ-300), 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. Each manufacturer of a sunlamp product and ultraviolet lamp shall provide or cause to be provided to purchasers and, upon request, to others at a cost not to exceed the cost of publication and distribution, adequate instructions for use to avoid or to minimize potential injury to the user, including the following technical and safety information as applicable:

(1) Sunlamp products. The users' instructions for a sunlamp product shall contain:

(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. 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]

§ 1040.30 High-intensity

vapor discharge lamps.

mercury

(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 ex

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 emissi on 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:

(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

1 Copies are available from American National Standards Institute, 1430 Broadway, New York, NY 10018.

194-069 D-01--21

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 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]

§ 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) Marimum 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 p1(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 incorporated 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