(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.
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