| (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. (32) Medical event--Any adverse patient health effect that is a result of failure or misuse of laser safety equipment. (33) Mobile service operation--The provision of lasers and personnel at temporary sites for limited time periods. The lasers may be fixed inside a motorized vehicle or may be a portable laser that may be removed from the vehicle and taken into a facility for use. (34) Nominal hazard zone (NHZ)--The space within which the level of direct, reflected, or scattered radiation during operation exceeds the applicable MPE. Exposure levels beyond the boundary of the NHZ are below the applicable MPE level. (35) Optical density (Dλ )--The logarithm to the base ten of the reciprocal of the transmittance. Dλ = -log10 τ λ , where τλ is transmittance. (36) Practitioner of the healing arts (practitioner)--For the purposes of this section, a person licensed to practice the healing arts by either the Texas Medical Board as a physician; the Texas State Board of Dental Examiners; the Texas Board of Chiropractic Examiners; or the Texas State Board of Podiatric Medicine. A practitioner's use of a laser is limited to his/her scope of professional practice as determined by the appropriate licensing agency. (37) Protective housing--An enclosure surrounding the laser that prevents access to laser radiation above the applicable MPE level. The aperture through which the useful beam is emitted is not part of the protective housing. The protective housing may enclose associated optics and a work station and shall limit access to other associated radiant energy emissions and to electrical hazards associated with components and terminals. (38) Provider of lasers--Provision of lasers on a routine basis to a facility for limited time periods. (39) Pulse duration--The duration of a laser pulse. This is usually measured as the time interval between the half-power points on the leading and trailing edges of the laser pulse. (40) Pulsed laser--A laser that delivers its energy in the form of a single pulse or a train of pulses. In this section, the duration of a pulse is <5seconds. (41) Reflection--The deviation of radiation following incidence on a surface. (42) Source--A laser or a laser-illuminated reflecting surface. (43) Transmission--Passage of radiation through a medium. (44) Ultraviolet radiation--Electromagnetic radiation with wavelengths shorter than those of visible radiation; for the purposes of this section 0.18 to 0.4 µm. (45) Visible radiation (light)--In this section, the term is used to describe electromagnetic radiation that can be detected by the human eye. This term is commonly used to describe wavelengths that lie in the range of 0.4 to 0.7 µm. (46) Watt--The unit of power or radiant flux. 1 watt equals 1 joule per second. (47) Wavelength (λ)--The distance between two successive points on a periodic wave that have the same phase. (e) Exemptions. (1) Lasers in transit or in storage incident to transit are exempt from the requirements of this section. This exemption does not apply to the providers of lasers. (2) Inoperable lasers are exempt from the requirements of this section. (3) Class 1 (I), IEC Class 1 and 1M, Class 2 (II), IEC Class 2 and 2M, and Class 3a (IIIa), IEC Class 3R lasers or products and IPL devices are exempt from the registration requirements of subsections (f) and (g) of this section. (4) Facilities, including academic institutions and research or development facilities, registered for the use of lasers are exempt from the registration requirements of subsections (f) of this section, regarding laser services, and the applicable paragraphs of subsection (g) of this section, to the extent that their personnel perform laser services only for the registrant by whom they are employed. (f) Registration of use of Class 3b and 4 lasers and laser services. (1) For purposes of this section, use of Class 3b or 4 lasers and laser services shall include, but may not be limited to: Cont'd... |
