cfr_sections
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
4 rows where part_number = 1040 and title_number = 21 sorted by section_id
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| section_id ▼ | title_number | title_name | chapter | subchapter | part_number | part_name | subpart | subpart_name | section_number | section_heading | agency | authority | source_citation | amendment_citations | full_text |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 21:21:8.0.1.3.45.0.1.1 | 21 | Food and Drugs | I | J | 1040 | PART 1040—PERFORMANCE STANDARDS FOR LIGHT-EMITTING PRODUCTS | § 1040.10 Laser products. | FDA | [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] | (a) Applicability. 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, 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. As used in this section and § 1040.11, the following definitions apply:… | |||||
| 21:21:8.0.1.3.45.0.1.2 | 21 | Food and Drugs | I | J | 1040 | PART 1040—PERFORMANCE STANDARDS FOR LIGHT-EMITTING PRODUCTS | § 1040.11 Specific purpose laser products. | FDA | [50 FR 33702, Aug. 20, 1985] | (a) Medical laser products. 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 in excess of the accessible emission limits of Class I, a label bearing the wording: “Laser aperture.” (b) Surveying, leveling, and alignment laser products. Each surveying, leveling. or alignment laser product shall comply with all of the applicable requirements of § 1040.10 for a Class I, IIa, II or IIIa laser product and shall not permit human access to laser radiation in excess of the accessible emission limits of Class IIIa. (c) Demonstration laser products. Each demonstration laser product shall comply with all of the applicable requirements of § 1040.10 for a Class I, IIa, II, or IIIa laser product and shall not permit human access to laser radiation in excess of the accessible emission limits of Class I and, if applicable, Class IIa, Class II, or Class IIIa. | |||||
| 21:21:8.0.1.3.45.0.1.3 | 21 | Food and Drugs | I | J | 1040 | PART 1040—PERFORMANCE STANDARDS FOR LIGHT-EMITTING PRODUCTS | § 1040.20 Sunlamp products and ultraviolet lamps intended for use in sunlamp products. | FDA | [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] | (a) Applicability. (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. (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 of November 9, 1979 (44 FR 65357). (b) Definitions. As used in this section the following definitions apply: (1) Exposure position 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. (2) Intended means the same as “intended uses” in § 801.4. (3) Irradiance 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 2 ). (4) Maximum exposure time means the greatest continuous exposure time interval recommended by the manufacturer of the product. (5) Maximum timer interval means the greatest time interval setting on the timer of a product. (6) Protective eyewear means any device designed to be worn by users of a product to reduce exposure of the eyes to radiation emitted by the product. (7) Spectral irradiance means the irradiance resulting from radiation within a wavelength range divided by the wavelength range as the range becomes vanishingly small, expressed in units of watts per square centimeter per nanometer (W/(cm 2 /nm)). (8) Spectral transmittance means the spectral irradiance transmitted through protective eyewear divided by the spectral irradiance incident on the protective eyewear. (9) Sunlamp product means any electronic product designed to incorp… | |||||
| 21:21:8.0.1.3.45.0.1.4 | 21 | Food and Drugs | I | J | 1040 | PART 1040—PERFORMANCE STANDARDS FOR LIGHT-EMITTING PRODUCTS | § 1040.30 High-intensity mercury vapor discharge lamps. | FDA | [44 FR 52195, Sept. 7, 1979, as amended at 53 FR 11254, Apr. 6, 1988] | (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. 1 Copies are available from Ameri… |
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CREATE TABLE cfr_sections (
section_id TEXT PRIMARY KEY,
title_number INTEGER,
title_name TEXT,
chapter TEXT,
subchapter TEXT,
part_number TEXT,
part_name TEXT,
subpart TEXT,
subpart_name TEXT,
section_number TEXT,
section_heading TEXT,
agency TEXT,
authority TEXT,
source_citation TEXT,
amendment_citations TEXT,
full_text TEXT
);
CREATE INDEX idx_cfr_title ON cfr_sections(title_number);
CREATE INDEX idx_cfr_part ON cfr_sections(part_number);
CREATE INDEX idx_cfr_agency ON cfr_sections(agency);