Applicability.(a) The provisions of this section and § 1040.11, as amended, are applicable as specified to all laser products manufactured or assembled after August 1, 1976, except when:
(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,…
Medical laser products.(a) Each medical laser product shall comply with all of the applicable requirements of § 1040.10 for laser products of its class. In addition, the manufacturer shall:
(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…
§ 1040.20Sunlamp products and ultraviolet lamps intended for use in sunlamp products.
Applicability.(a) (1) The provisions of this section, as amended, are applicable as specified herein to the following products manufactured on or after September 8, 1986.
(i) Any sunlamp product.
(ii) Any ultraviolet lamp intended for use in any sunlamp product.
Federal Register04(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 of November 9, 1979 (44 FR 65357).
Definitions.(b) As used in this section the following definitions apply:
Exposure position(1) means any position, distance, orientation, or location relative to the radiating surfaces of the sunlamp product at which the user is intended to be exposed to ultraviolet radiation from the product, as recommended by the manufacturer.
Intended(2) means the same as “intended uses” in § 801.4.
Irradiance2(3) means the radiant power incident on a surface at a specified location and orientation relative to the radiating surface divided by the area of the surface, as the area becomes vanishingly small, expressed in units of watts per square centimeter (W/cm ).
Maximum exposure time(4) means the…
§ 1040.30High-intensity mercury vapor discharge lamps.
Applicability.(a) 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.
Definitions.High-intensity mercury vapor discharge lamp(b) (1) 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.
Advertisement(2) 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.
Packaging(3) 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.
Outer envelope(4) means the lamp element, usually glass, surrounding a high-pressure arc…
