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TITLE 25HEALTH SERVICES
PART 1DEPARTMENT OF STATE HEALTH SERVICES
CHAPTER 289RADIATION CONTROL
SUBCHAPTER GREGISTRATION REGULATIONS
RULE §289.301Registration and Radiation Safety Requirements for Lasers and Intense-Pulsed Light Devices

(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 the responsibilities of the registrant and the laser safety officer (LSO), laser and IPL device hazard control methods, training requirements, and notification of injuries.

  (2) For the purpose of this section, any reference to a class of laser includes both International Electrotechnical Commission (IEC) and United States Food and Drug Administration (FDA) classifications, as appropriate.

  (3) This section establishes requirements for the registration of a person who receives, possesses, acquires, uses, or transfers Class IIIb (3B), or Class IV (4) lasers in the healing arts, veterinary medicine, and industrial, academic, research and development institutions, and of a person in the business of providing laser services.

    (A) A person must not use a Class 3B or Class 4 laser or perform laser services except as authorized in a certificate of registration issued by the Texas Department of State Health Services (department) as specified in this section.

    (B) A person who receives, possesses, uses, owns, or acquires a Class 3B or Class 4 laser before receiving a certificate of registration is subject to the requirements of this chapter.

  (4) Class I (1) lasers, Class II (2) lasers, FDA Class IIIa (3a) lasers, IEC Class 3R lasers, and IPL devices are not required to be registered. However, the use of Class 1, Class 2, Class 3a, Class 3R lasers, and IPL devices is subject to applicable requirements in this section.

(b) Scope.

  (1) Except as otherwise provided, this section applies to a person who receives, possesses, acquires, transfers, or uses lasers that emit or may emit laser radiation. Lasers or IPL devices must not be used on humans or animals unless under the supervision of a licensed practitioner of the healing arts (practitioner) or veterinary medicine and unless the use of lasers or IPL devices is within the scope of their professional license. This section does not limit the intentional exposure of patients to laser or IPL device radiation for the purpose of diagnosis, therapy, or treatment by a practitioner of the healing arts or veterinary medicine within the scope of their professional license. This section does not apply to the manufacture of lasers or IPL devices.

  (2) This section applies to lasers operating at wavelengths between 180 nanometers (nm) and 1 millimeter (mm).

  (3) This section applies to IPL devices. These devices must be Class 2 or Class 3 surgical devices certified as complying with the designing, labeling, and manufacturing standards of the FDA.

  (4) This section applies to lasers meeting the requirements of IEC standards 60825-1 and 60601-2-22 as allowed by the FDA Centers for Devices and Radiological Health in the current Laser Notice guidance document.

  (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 chapter (relating to Notices, Instructions, and Reports to Workers; Inspections) except for 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 chapter (relating to Fees for Certificates of Registration, Radioactive Material Licenses, Emergency Planning and Implementation, and Other Regulatory Services);

    (C) §289.205 (a), (b), and (h) - (n) of this chapter (relating to Hearing and Enforcement Procedures); and

    (D) §289.231 (d), (f) - (j), (aa), (bb), (ff), (kk), and (ll)(1), (2), and (5) of this chapter (relating to General Provisions and Standards for Protection Against Machine-Produced Radiation) and the applicable definitions in §289.231(c) of this chapter.

(c) Prohibitions.

  (1) The department prohibits the use of lasers and IPL devices posing a significant threat or endangering occupational or public health and safety as specified in §289.205 and §289.231 of this chapter.

  (2) An individual must not be intentionally exposed to laser or IPL radiation above the maximum permissible exposure (MPE) unless a practitioner has authorized such exposure.

    (A) Exposure of an individual for training, demonstration, or other non-healing arts purposes is prohibited unless authorized by a practitioner.

    (B) Exposure of an individual for the purpose of healing arts screening is prohibited, except as specifically authorized by the department.

    (C) Research and development using radiation machines on humans is prohibited except for the following.

      (i) Any research using radiation machines on humans must be approved by an Institutional Review Board (IRB) as required by 45 Code of Federal Regulations (CFR) Part 46, and 21 CFR Part 56. The IRB must include at least one physician to direct any laser radiation or IPL device use as specified in subsection (b)(1) of this section.

      (ii) Facilities with radiation machines, with investigational device exemptions, involved in clinical studies must follow regulations governing the conduct of clinical studies and applying to the manufacturers, sponsors, clinical investigators, IRBs, and the medical device. These regulations include:

        (I) 21 CFR Part 812, Investigational Device Exemptions;

        (II) 21 CFR Part 50, Protection of Human Subjects;

        (III) 21 CFR Part 56, Institutional Review Boards;

        (IV) 21 CFR Part 54, Financial Disclosure by Clinical Investigators; and

        (V) 21 CFR Part 820, Subpart C, Design Controls of the Quality System Regulation.

(d) Definitions. The following words and terms, when used in this section, have the following meanings, unless the context indicates otherwise.

  (1) Access to laser radiation--Proximity to radiation 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 not blocked by an intervening barrier or filter.

  (4) American National Standards Institute (ANSI) standards--Specific standards for lasers and IPL devices published by the American National Standards Institute.

  (5) Aperture--An opening through which radiation can pass.

  (6) Beam--A collection of rays characterized by direction, diameter (or dimensions), and divergence (or convergence).

  (7) Class 1 laser--Any laser not permitting human exposure during operation to levels of visible laser radiation more than the accessible emission limits contained in ANSI.

  (8) Class 2 laser--Any laser permitting human exposure during operation to levels of visible laser radiation more than the accessible emission limits of Class 1 lasers contained in ANSI but does not permit human exposure during operation to levels of visible laser radiation more than the accessible emission limits of Class 2 lasers contained in ANSI.

  (9) Class 3a laser, IEC Class 3R--Any laser permitting human exposure during operation to levels of laser radiation more than the accessible emission limits of Class 2 lasers contained in ANSI but does not permit human exposure during operation to levels of laser radiation more than the accessible emission limits of Class 3a lasers contained in ANSI.

  (10) Class 3B laser--Any laser permitting human exposure during operation to levels of laser radiation more than the accessible emission limits of FDA Class 3a lasers in ANSI but does not permit human exposure during operation to levels of laser radiation in excess of the emission limits of Class 3B lasers contained in ANSI.

  (11) Class 4 laser--Any laser permitting human exposure during operation to levels of laser radiation more than the accessible emission limits of Class 3B lasers contained in ANSI.

  (12) Coherent--A light beam is coherent when the electric vector at any point in it is related to 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 are found in 21 CFR §1040.10.

  (14) Continuous wave--A laser operating with a continuous output for greater than or equal to 0.25 seconds is regarded as a continuous wave laser.

  (15) Controlled area--An area where the occupancy and activity of those within are subject to control and supervision by the registrant for the purpose of protection from radiation hazards.

Cont'd...

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