| (a) Purpose. (1) This section establishes requirements for protection against all classes of laser radiation and intense-pulsed light (IPL) device hazards. This section includes responsibilities of the registrant and the laser safety officer (LSO), laser and IPL device hazard control methods, training requirements, and notification of injuries. (2) This section establishes requirements for the registration of persons who receive, possess, acquire, transfer, or use Class 3b (IIIb), International Electrotechnical Commission (IEC) Class 3B and Class 4 (IV), IEC Class 4 lasers in the healing arts, veterinary medicine, industry, academic, research and development institutions, and of persons who are in the business of providing laser services. No person shall use Class 3b (IIIb), IEC Class 3B or 4 (IV), IEC Class 4 lasers or perform laser services except as authorized in a certificate of laser registration issued by the agency in accordance with the requirements of this section. Class 1 (I) lasers, IEC Class 1 and 1M, Class 2 (II) lasers, IEC Class 2 and 2M, and Class 3a (IIIa) lasers, IEC Class 3R and IPL devices are not required to be registered. However, use of Class 1 (I) lasers, IEC Class 1 and 1M, Class 2 (II) lasers, IEC Class 2 and 2M, and Class 3a (IIIa) lasers, IEC Class 3R and IPL devices are subject to other applicable requirements in this section. (b) Scope. (1) Except as otherwise specifically provided, this section applies to all persons who receive, possess, acquire, transfer, or use lasers that emit or may emit laser radiation. Individuals shall not use lasers or IPL devices on humans unless under the supervision of a licensed practitioner of the healing arts and unless the use of lasers or IPL devices is within the scope of practice of their professional license. Nothing in this section shall be interpreted as limiting the intentional exposure of patients to laser or IPL device radiation for the purpose of diagnosis, therapy, or treatment by a licensed practitioner of the healing arts within the scope of practice of their professional license. This section does not apply to the manufacture of lasers or IPL devices. (2) This section applies to lasers that operate at wavelengths between 180 nanometers (nm) and 1 millimeter (mm). (3) This section applies to IPL devices. These devices shall be Class 2 or Class 3 surgical devices certified as complying with the design, labeling, and manufacturing standards of the United States Food and Drug Administration (FDA). (4) This section applies to lasers that meet the requirements of IEC standards 60825-1 and 60601-2-22 as allowed by the United States Food and Drug Administration Centers for Devices and Radiological Health in guidance document, Laser Notice No.50, dated July 26, 2001. (5) In addition to the requirements of this section, all registrants authorized to use Class 3b and Class 4 lasers are subject to the following requirements: (A) §289.203 of this title (relating to Notices, Instructions, and Reports to Workers; Inspections) with the exception of subsection (d), "Notifications and reports to individuals" and information relating to ionizing radiation or exposure history contained in subsection (i), "Notice to employees." (B) §289.204 of this title (relating to Fees for Certificates of Registration, Radioactive Material Licenses, Emergency Planning and Implementation, and Other Regulatory Services); (C) subsections (a), (b), and (h) - (n) of §289.205 of this title (relating to Hearing and Enforcement Procedures); and (D) subsections (d), (f) - (j), (aa), (bb), (ff), (kk), and (ll)(1), (2), and (5) of §289.231 of this title (relating to General Provisions and Standards for Protection Against Machine-Produced Radiation) and the applicable definitions in subsection (c) of §289.231 of this title. (c) Prohibitions. (1) The agency may prohibit the use of lasers and IPL devices that pose significant threat or endanger occupational or public health and safety, in accordance with §289.205 of this title and §289.231 of this title. (2) Individuals shall not be intentionally exposed to laser and IPL radiation above the maximum permissible exposure (MPE) unless such exposure has been authorized by a licensed practitioner of the healing arts. (A) Exposure of an individual for training, demonstration, or other non-healing arts purposes is prohibited unless authorized by a licensed practitioner of the healing arts. (B) Exposure of an individual for the purpose of healing arts screening is prohibited, except as specifically authorized by the agency. (C) Exposure of an individual for the purpose of research is prohibited, except as authorized in research studies. Any research using radiation-producing devices on humans must be approved by an institutional review board (IRB) as required by Title 45, Code of Federal Regulations (CFR), Part 46 and Title 21, CFR, Part 56. The IRB must include at least one practitioner of the healing arts to direct use of laser and IPL device radiation in accordance with subsection (b)(1) of this section. (d) Definitions. The following words and terms, when used in this section, shall have the following meanings, unless the context clearly indicates otherwise. (1) Access to laser radiation--Proximity to radiation that is not blocked by an intervening barrier or filter. (2) Accessible emission limit (AEL)--The maximum accessible emission level permitted within a particular class. (3) Accessible laser radiation--Proximity to radiation that is not blocked by an intervening barrier or filter. (4) Aperture--An opening through which radiation can pass. (5) Apparent visual angle--The angular subtense of the source as calculated from source size and distance from the eye. It is not the beam divergence of the source. (6) Beam--A collection of rays characterized by direction, diameter (or dimensions), and divergence (or convergence). (7) Class 1 (I) laser, IEC Class 1 and 1M--Any laser that does not permit access during the operation to levels of laser radiation in excess of the accessible emission limits contained in American National Standards Institute (ANSI) Z136.1-2000, Safe Use of Lasers. (8) Class 2 (II) laser, IEC Class 2 and 2M--Any laser that permits human access during operation to levels of visible laser radiation in excess of the accessible emission limits of Class 1 lasers contained in ANSI Z136.1-2000, Safe Use of Lasers, but does not permit human access during operation to levels of laser radiation in excess of the accessible emission limits of Class 2 lasers contained in ANSI Z136.1-2000, Safe Use of Lasers. (9) Class 3a (IIIa) laser, IEC Class 3R--Any laser that permits human access during operation to levels of visible laser radiation in excess of the accessible emission limits of Class 2 lasers contained in ANSI Z136.1-2000, Safe Use of Lasers, but does not permit human access during operation to levels of laser radiation in excess of the accessible emission limits of Class 3a lasers contained in ANSI Z136.1-2000, Safe Use of Lasers. (10) Class 3b (IIIb) laser, IEC Class 3B--Any laser that permits human access during operation to levels of laser radiation in excess of the accessible emission limits of Class 3a lasers in ANSI Z136.1-2000, Safe Use of Lasers but does not permit human access during operation to levels of laser radiation in excess of the emission limits of Class 3b lasers contained in ANSI Z136.1-2000, Safe Use of Lasers. (11) Class 4 (IV) laser, IEC Class 4--Any laser that permits human access during operation to levels of laser radiation in excess of the accessible emission limits of Class 3b lasers contained in the most recent edition of ANSI Z136.1-2000, Safe Use of Lasers. (12) Coherent--A light beam is said to be coherent when the electric vector at any point in it is related to that at any other point by a definite, continuous function. (13) Collateral radiation--Any electromagnetic radiation, except laser radiation, emitted by a laser that is physically necessary for its operation. The applicable, accessible emission limits for collateral radiation may be found in Title 21, CFR, Part 1040.10. (14) Continuous wave--The output of a laser that is operated in a continuous rather than a pulsed mode. In this section, a laser operating with a continuous output for a period of ≥0.25 seconds is regarded as a continuous wave laser. (15) Controlled area--An area where the occupancy and activity of those within is subject to control and supervision by the registrant for the purpose of protection from radiation hazards. (16) Divergence--For the purposes of this section, divergence is taken as the plane angle projection of the cone that includes 1 - 1/e (for example 63.2%) of the total radiant energy or power. The value of the divergence is expressed in radians or milliradians. (17) Electromagnetic radiation--The flow of energy consisting of orthogonally vibrating electric and magnetic fields lying transverse to the direction of propagation. X-ray, ultraviolet, visible, infrared, and radio waves occupy various portions of the electromagnetic spectrum and differ only in frequency, wavelength, or photon energy. (18) Electronic product--Any product or article defined as follows: (A) any manufactured or assembled product that, when in operation: (i) contains or acts as part of an electronic circuit; and (ii) emits, or in the absence of effective shielding or other controls would emit, electronic product radiation; or (B) any manufactured or assembled article that is intended for use as a component, part, or accessory of a product described in subparagraph (A) of this paragraph and that when in operation emits, or in the absence of effective shielding or other controls would emit, such radiation. (19) Energy--The capacity for doing work. Energy content is commonly used to characterize the output from pulsed lasers, and is generally expressed in joules (J). (20) Healing arts--Any system, treatment, operation, diagnosis, prescription, or practice for the ascertainment, cure, relief, palliation, adjustment, or correction of any human disease, ailment, deformity, injury, or unhealthy or abnormal physical or mental condition. (21) Infrared radiation--The region of the electromagnetic spectrum between the long-wavelength extreme of the visible spectrum (about 0.7 µm) and the shortest microwaves (about 1 mm). (22) Inoperable--Incapable of operation by reason of damage, disassembly, removal, or inactivation of key components that cannot be restored without significant repair or renovation. (23) Institutional Review Board (IRB)--Any board, committee, or other group formally designated by an institution to review, approve the initiation of, and conduct periodic review of biomedical research involving human subjects. (24) Intense-pulsed light (IPL) device--A device that emits radiation to energy density levels that could reasonably cause bodily harm and that is used for photothermolysis. This device is a Class 2 or Class 3 surgical device certified as complying with the design, labeling, and manufacturing standards of the United States Food and Drug Administration (FDA). (25) Invisible radiation--Laser or collateral radiation having wavelengths of equal to or greater than 180 nm but less than or equal to 400 nm or greater than 710 nm but less than or equal to 1.0 x 106 nm (1 millimeter). (26) Irradiance--Radiant power incident per unit area upon a surface, expressed in watts-per-square-centimeter (W-cm-2 ). (27) Joule--A unit of energy. One joule is equal to one watt • second. (28) Laser--An electronic device that emits stimulated radiation to energy density levels that could reasonably cause bodily harm. A laser may also produce an intense, coherent, directional beam of light by stimulating electronic or molecular transitions to lower energy levels. The term "laser" also includes the assembly of electrical, mechanical, and optical components associated with the laser. A laser can be a component of a product or system. (29) Laser product--Any manufactured product or assemblage of components that constitutes, incorporates, or is intended to incorporate a laser and is classified as a Class 1 (I), IEC Class 1 and 1M, Class 2 (II), IEC Class 2 and 2M, Class 3a (IIIa), IEC Class 3R, Class 3b (IIIb), IEC Class 3B or Class 4 (IV), IEC Class 4 laser product according to the performance standards set by the United States Food and Drug Administration (FDA). A laser that is intended for use as a component of an electronic product shall itself be considered a laser product. A laser product can contain an enclosed laser with an assigned class number higher than the inherent capability of the laser product in which it is incorporated and where the product's lower classification is appropriate due to the engineering features limiting accessible emission. (30) Laser safety officer (LSO)--An individual who has a knowledge of and the authority and responsibility to apply appropriate laser radiation protection rules, standards, and practices, and who must be specifically authorized on a certificate of laser registration. (31) Maximum permissible exposure (MPE)--The level of laser radiation to which a person may be exposed without hazardous effect or adverse biological changes in the eye or skin. For the purposes of this section, maximum permissible exposures for laser radiation may be found in ANSI Z136.1-2000, Safe Use of Lasers. Cont'd... |
