[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1040.10]
[Page 623-640]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 1040--PERFORMANCE STANDARDS FOR LIGHT-EMITTING PRODUCTS--Table of Contents
Sec. 1040.10 Laser products.
(a) Applicability. The provisions of this section and Sec. 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
Sec. 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, Office of Compliance (HFZ-300), Center for Devices and
Radiological Health, 2094 Gaither Rd., Rockville, MD 20850.
(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 Sec. 1002.31.
(b) Definitions. As used in this section and Sec. 1040.11, the
following definitions apply:
(1) Accessible emission level means the magnitude of accessible
laser or collateral radiation of a specific wavelength and emission
duration at a particular point as measured according to paragraph (e) of
this section. Accessible
[[Page 624]]
laser or collateral radiation is radiation to which human access is
possible, as defined in paragraphs (b) (12), (15), and (22) of this
section.
(2) Accessible emission limit means the maximum accessible emission
level permitted within a particular class as set forth in paragraphs
(c), (d), and (e) of this section.
(3) Aperture means any opening in the protective housing or other
enclosure of a laser product through which laser or collateral radiation
is emitted, thereby allowing human access to such radiation.
(4) Aperture stop means an opening serving to limit the size and to
define the shape of the area over which radiation is measured.
(5) Class I laser product means any laser product that does not
permit access during the operation to levels of laser radiation in
excess of the accessible emission limits contained in table I of
paragraph (d) of this section.\1\
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\1\ Class I levels of laser radiation are not considered to be
hazardous.
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(6) Class IIa laser product means any laser product that permits
human access during operation to levels of visible laser radiation in
excess of the accessible emission limits contained in table I, but does
not permit human access during operation to levels of laser radiation in
excess of the accessible emission limits contained in table II-A of
paragraph (d) of this section.\2\
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\2\ Class IIa levels of laser radiation are not considered to be
hazardous if viewed for any period of time less than or equal to 1 x
10\3\ seconds but are considered to be a chronic viewing hazard for any
period of time greater than 1 x 10\3\ seconds.
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(7) Class II laser product means any laser product that permits
human access during operation to levels of visible laser radiation in
excess of the accessible emission limits contained in table II-A, but
does not permit human access during operation to levels of laser
radiation in excess of the accessible emission limits contained in table
II of paragraph (d) of this section.\3\
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\3\ Class II levels of laser radiation are considered to be a
chronic viewing hazard.
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(8) Class IIIa laser product means any laser product that permits
human access during operation to levels of visible laser radiation in
excess of the accessible emission limits contained in table II, but does
not permit human access during operation to levels of laser radiation in
excess of the accessible emission limits contained in table III-A of
paragraph (d) of this section.\4\
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\4\ Class IIIa levels of laser radiation are considered to be,
depending upon the irradiance, either an acute intrabeam viewing hazard
or chronic viewing hazard, and an acute viewing hazard if viewed
directly with optical instruments.
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(9) Class IIIb laser product means any laser product that permits
human access during operation to levels of laser radiation in excess of
the accessible emission limits of table III-A, but does not permit human
access during operation to levels of laser radiation in excess of the
accessible emission limits contained in table III-B of paragraph (d) of
this section.\5\
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\5\ Class IIIb levels of laser radiation are considered to be an
acute hazard to the skin and eyes from direct radiation.
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(10) Class III laser product means any Class IIIa or Class IIIb
laser product.
(11) Class IV laser product means any laser that permits human
access during operation to levels of laser radiation in excess of the
accessible emission limits contained in table III-B of paragraph (d) of
this section.\6\
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\6\ Class IV levels of laser radiation are considered to be an acute
hazard to the skin and eyes from direct and scattered radiation.
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(12) Collateral radiation means any electronic product radiation,
except laser radiation, emitted by a laser product as a result of the
operation of the laser(s) or any component of the laser product that is
physically necessary for the operation of the laser(s).
(13) Demonstration laser product means any laser product
manufactured, designed, intended, or promoted for purposes of
demonstration, entertainment, advertising display, or artistic
composition. The term ``demonstration laser product'' does not apply to
laser products which are not manufactured, designed, intended, or
promoted for such purposes, even though they may be used for those
purposes or are intended to demonstrate other applications.
(14) Emission duration means the temporal duration of a pulse, a
series of
[[Page 625]]
pulses, or continuous operation, expressed in seconds, during which
human access to laser or collateral radiation could be permitted as a
result of operation, maintenance, or service of a laser product.
(15) Human access means the capacity to intercept laser or
collateral radiation by any part of the human body. For laser products
that contain Class IIIb or IV levels of laser radiation, ``human
access'' also means access to laser radiation that can be reflected
directly by any single introduced flat surface from the interior of the
product through any opening in the protective housing of the product.
(16) Integrated radiance means radiant energy per unit area of a
radiating surface per unit solid angle of emission, expressed in joules
per square centimeter per steradian (Jcm-2 sr-1).
(17) Invisible radiation means 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).
(18) Irradiance means the time-averaged radiant power incident on an
element of a surface divided by the area of that element, expressed in
watts per square centimeter (W cm-2).
(19) Laser means any device that can be made to produce or amplify
electromagnetic radiation at wavelenghts greater than 250 nm but less
than or equal to 13,000 nm or, after August 20, 1986, at wavelengths
equal to or greater than 180 nm but less than or equal to
1.0X106 nm primarily by the process of controlled stimulated
emission.
(20) Laser energy source means any device intended for use in
conjunction with a laser to supply energy for the operation of the
laser. General energy sources such as electrical supply mains or
batteries shall not be considered to constitute laser energy sources.
(21) Laser product means any manufactured product or assemblage of
components which constitutes, incorporates, or is intended to
incorporate a laser or laser system. A laser or laser system that is
intended for use as a component of an electronic product shall itself be
considered a laser product.
(22) Laser radiation means all electromagnetic radiation emitted by
a laser product within the spectral range specified in paragraph (b)(19)
of this section that is produced as a result of controlled stimulated
emission or that is detectable with radiation so produced through the
appropriate aperture stop and within the appropriate solid angle of
acceptance, as specified in paragraph (e) of this section.
(23) Laser system means a laser in combination with an appropriate
laser energy source with or without additional incorporated components.
See paragraph (c)(2) of this section for an explanation of the term
``removable laser system.''
(24) Maintenance means performance of those adjustments or
procedures specified in user information provided by the manufacturer
with the laser product which are to be performed by the user for the
purpose of assuring the intended performance of the product. It does not
include operation or service as defined in paragraph (b) (27) and (38)
of this section.
(25) Maximum output means the maximum radiant power and, where
applicable, the maximum radiant energy per pulse of accessible laser
radiation emitted by a laser product during operation, as determined
under paragraph (e) of this section.
(26) Medical laser product means any laser product which is a
medical device as defined in 21 U.S.C. 321(h) and is manufactured,
designed, intended or promoted for in vivo laser irradiation of any part
of the human body for the purpose of: (i) Diagnosis, surgery, or
therapy; or (ii) relative positioning of the human body.
(27) Operation means the performance of the laser product over the
full range of its functions. It does not include maintenance or service
as defined in paragraphs (b) (24) and (38) of this section.
(28) Protective housing means those portions of a laser product
which are designed to prevent human access to laser or collateral
radiation in excess of the prescribed accessible emission limits under
conditions specified in this section and in Sec. 1040.11.
(29) Pulse duration means the time increment measured between the
half-
[[Page 626]]
peak-power points at the leading and trailing edges of a pulse.
(30) Radiance means time-averaged radiant power per unit area of a
radiating surface per unit solid angle of emission, expressed in watts
per square centimeter per steradian (W cm-2 sr-1).
(31) Radiant energy means energy emitted, transferred or received in
the form of radiation, expressed in joules (J).
(32) Radiant exposure means the radiant energy incident on an
element of a surface divided by the area of the element, expressed in
joules per square centimeter (Jcm-2)
(33) Radiant power means time-averaged power emitted, transferred or
received in the form of radiation, expressed in watts (W).
(34) Remote interlock connector means an electrical connector which
permits the connection of external remote interlocks.
(35) Safety interlock means a device associated with the protective
housing of a laser product to prevent human access to excessive
radiation in accordance with paragraph (f)(2) of this section.
(36) Sampling interval means the time interval during which the
level of accessible laser or collateral radiation is sampled by a
measurement process. The magnitude of the sampling interval in units of
seconds is represented by the symbol (t).
(37) Scanned laser radiation means laser radiation having a time-
varying direction, origin or pattern of propagation with respect to a
stationary frame of reference.
(38) Service means the performance of those procedures or
adjustments described in the manufacturer's service instructions which
may affect any aspect of the product's performance for which this
section and Sec. 1040.11 have applicable requirements. It does not
include maintenance or operation as defined in paragraphs (b) (24) and
(27) of this section.
(39) Surveying, leveling, or alignment laser product means a laser
product manufactured, designed, intended or promoted for one or more of
the following uses:
(i) Determining and delineating the form, extent, or position of a
point, body, or area by taking angular measurement.
(ii) Positioning or adjusting parts in proper relation to one
another.
(iii) Defining a plane, level, elevation, or straight line.
(40) Visible radiation means laser or collateral radiation having
wavelengths of greater than 400 nm but less than or equal to 710 nm.
(41) Warning logotype means a logotype as illustrated in either
figure 1 or figure 2 of paragraph (g) of this section.
(42) Wavelength means the propagation wavelength in air of
electromagnetic radiation.
(c) Classification of laser products-- (1) All laser products. Each
laser product shall be classified in Class I, IIa, II, IIIa, IIIb, or IV
in accordance with definitions set forth in paragraphs (b) (5) through
(11) of this section. The product classification shall be based on the
highest accessible emission level(s) of laser radiation to which human
access is possible during operation in accordance with paragraphs (d),
(e), and (f)(1) of this section.
(2) Removable laser systems. Any laser system that is incorporated
into a laser product subject to the requirements of this section and
that is capable, without modification, of producing laser radiation when
removed from such laser product, shall itself be considered a laser
product and shall be separately subject to the applicable requirements
in this subchapter for laser products of its class. It shall be
classified on the basis of accessible emission of laser radiation when
so removed.
(d) Accessible emission limits. Accessible emission limits for laser
radiation in each class are specified in tables I, II-A, II, III-A, and
III-B of this paragraph. The factors, k1 and k2
vary with wavelength and emission duration. These factors are given in
table IV of this paragraph, with selected numerical values in table V of
this paragraph. Accessible emission limits for collateral radiation are
specified in table VI of this paragraph.
[[Page 627]]
Notes applicable to tables I, II-A, II, III-A and III-B:
(1) The factors k1 and k2 are wavelength-
dependent correction factors determined from table IV.
(2) The variable t in the expressions of emission limits is the
magnitude of the sampling interval in units of seconds.
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[[Page 628]]
[GRAPHIC] [TIFF OMITTED] TR01FE93.032
[[Page 629]]
[GRAPHIC] [TIFF OMITTED] TR01FE93.033
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[GRAPHIC] [TIFF OMITTED] TR01FE93.034
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[GRAPHIC] [TIFF OMITTED] TR01FE93.035
[[Page 632]]
[GRAPHIC] [TIFF OMITTED] TR01FE93.036
(1) Beam of a single wavelength. Laser or collateral radiation of a
single wavelength exceeds the accessible emission limits of a class if
its accessible emission level is greater than the accessible emission
limit of that class within any of the ranges of emission duration
specified in tables I, II-A, II, III-A, and III-B of this paragraph.
(2) Beam of multiple wavelengths in same range. Laser or collateral
radiation having two or more wavelengths within any one of the
wavelength ranges specified in tables I, II-A, II, III-A, and III-B of
this paragraph exceeds the accessible emission limits of a class if the
sum of the ratios of the accessible emission level to the corresponding
accessible emission limit at each such wavelength is greater than unity
for that combination of emission duration and wavelength distribution
which results in the maximum sum.
(3) Beam with multiple wavelengths in different ranges. Laser or
collateral radiation having wavelengths within two or more of the
wavelength ranges specified in tables I, II-A, II, III-A, and III-B of
this paragraph exceeds the accessible emission limits of a class if it
exceeds the applicable limits within any one of those wavelength ranges.
This determination is made for each wavelength range in accordance with
paragraph (d) (1) or (2) of this section.
[[Page 633]]
(4) Class I dual limits. Laser or collateral radiation in the
wavelength range of greater than 400 nm but less than or equal to 1.400
nm exceeds the accessible emission limits of Class I if it exceeds both:
(i) The Class I accessible emission limits for radiant energy within
any range of emission duration specified in table I of this paragraph,
and
(ii) The Class I accessible emission limits for integrated radiance
within any range of emission duration specified in table I of this
paragraph.
(e) Tests for determination of compliance--(1) Tests for
certification. Tests on which certification under Sec. 1010.2 is based
shall account for all errors and statistical uncertainties in the
measurement process. Because compliance with the standard is required
for the useful life of a product such tests shall also account for
increases in emission and degradation in radiation safety with age.
(2) Test conditions. Except as provided in Sec. 1010.13, tests for
compliance with each of the applicable requirements of this section and
Sec. 1040.11 shall be made during operation, maintenance, or service as
appropriate:
(i) Under those conditions and procedures which maximize the
accessible emission levels, including start-up, stabilized emission, and
shut-down of the laser product; and
(ii) With all controls and adjustments listed in the operation,
maintenance, and service instructions adjusted in combination to result
in the maximum accessible emission level of radiation; and
(iii) At points in space to which human access is possible in the
product configuration which is necessary to determine compliance with
each requirement, e.g., if operation may require removal of portions of
the protective housing and defeat of safety interlocks, measurements
shall be made at points accessible in that product configuration; and
(iv) With the measuring instrument detector so positioned and so
oriented with respect to the laser product as to result in the maximum
detection of radiation by the instrument; and
(v) For a laser product other than a laser system, with the laser
coupled to that type of laser energy source which is specified as
compatible by the laser product manufacturer and which produces the
maximum emission level of accessible radiation from that product.
(3) Measurement parameters. Accessible emission levels of laser and
collateral radiation shall be based upon the following measurements as
appropriate, or their equivalent:
(i) For laser products intended to be used in a locale where the
emitted laser radiation is unlikely to be viewed with optical
instruments, the radiant power (W) or radiant energy (J) detectable
through a circular aperture stop having a diameter of 7 millimeters and
within a circular solid angle of acceptance of 1 X 10-3
steradian with collimating optics of 5 diopters or less. For scanned
laser radiation, the direction of the solid angle of acceptance shall
change as needed to maximize detectable radiation, with an angular speed
of up to 5 radians/second. A 50 millimeter diameter aperture stop with
the same collimating optics and acceptance angle stated above shall be
used for all other laser products (except that a 7 millimeter diameter
aperture stop shall be used in the measurement of scanned laser
radiation emitted by laser products manufactured on or before August 20,
1986.
(ii) The irradiance (W cm-2) or radiant exposure (J
cm-2 equivalent to the radiant power (W) or radiant energy
(J) detectable through a circular aperture stop having a diameter of 7
millimeters and, for irradiance, within a circular solid angle of
acceptance of 1 x 10-3 steradian with collimating optics of 5
diopters or less, divided by the area of the aperture stop
(cm-2).
(iii) The radiance (W cm-2 sr-1) or integrated
radiance (J cm-2 sr-1) equivalent to the radiant
power (W) or radiant energy (J) detectable through a circular aperture
stop having a diameter of 7 millimeters and within a circular solid
angle of acceptance of 1 X 10-5 steradian with collimating
optics of 5 diopters or less, divided by that solid angle (sr) and by
the area of the aperture stop (cm-2).
(f) Performance requirements--(1) Protective housing. Each laser
product shall have a protective housing that prevents human access
during operation
[[Page 634]]
to laser and collateral radiation that exceed the limits of Class I and
table VI, respectively, wherever and whenever such human access is not
necessary for the product to perform its intended function. Wherever and
whenever human access to laser radiation levels that exceed the limits
of Class I is necessary, these levels shall not exceed the limits of the
lowest class necessary to perform the intended function(s) of the
product.
(2) Safety interlocks. (i) Each laser product, regardless of its
class, shall be provided with at least one safety interlock for each
portion of the protective housing which is designed to be removed or
displaced during operation or maintenance, if removal or displacement of
the protective housing could permit, in the absence of such
interlock(s), human access to laser or collateral radiation in excess of
the accessible emission limit applicable under paragraph (f)(1) of this
section.
(ii) Each required safety interlock, unless defeated, shall prevent
such human access to laser and collateral radiation upon removal or
displacement of such portion of the protective housing
(iii) Either multiple safety interlocks or a means to preclude
removal or displacement of the interlocked portion of the protective
housing shall be provided, if failure of a single interlock would allow;
(a) Human access to a level of laser radiation in excess of the
accessible emission limits of Class IIIa; or
(b) Laser radiation in excess of the accessible emission limits of
Class II to be emitted directly through the opening created by removal
or displacement of the interlocked portion of the protective housing.
(iv) Laser products that incorporate safety interlocks designed to
allow safety interlock defeat shall incorporate a means of visual or
aural indication of interlock defeat. During interlock defeat, such
indication shall be visible or audible whenever the laser product is
energized, with and without the associated portion of the protective
housing removed or displaced.
(v) Replacement of a removed or displaced portion of the protective
housing shall not be possible while required safety interlocks are
defeated.
(3) Remote interlock connector. Each laser system classified as a
Class IIIb or IV laser product shall incorporate a readily available
remote interlock connector having an electrical potential difference of
no greater than 130 root-mean-square volts between terminals. When the
terminals of the connector are not electrically joined, human access to
all laser and collateral radiation from the laser product in excess of
the accessible emission limits of Class I and table VI shall be
prevented.
(4) Key control. Each laser system classified as a Class IIIb or IV
laser product shall incorporate a key-actuated master control. The key
shall be removable and the laser shall not be operable when the key is
removed.
(5) Laser radiation emission indicator. (i) Each laser system
classified as a Class II or IIIa laser product shall incorporate an
emission indicator that provides a visible or audible signal during
emission of accessible laser radiation in excess of the accessible
emission limits of Class I.
(ii) Each laser system classified as a Class IIIb or IV laser
product shall incorporate an emission indicator which provides a visible
or audible signal during emission of accessible laser radiation in
excess of the accessible emission limits of Class I, and sufficiently
prior to emission of such radiation to allow appropriate action to avoid
exposure to the laser radiation.
(iii) For laser systems manufactured on or before August 20, 1986,
if the laser and laser energy source are housed separately and can be
operated at a separation distance of greater than 2 meters, both laser
and laser energy source shall incorporate an emission indicator as
required in accordance with paragraph (f)(5) (i) or (ii) of this
section. For laser systems manufactured after August 20, 1986, each
separately housed laser and operation control of a laser system that
regulates the laser or collateral radiation emitted by a product during
operation shall incorporate an emission indicator as required in
accordance with paragraph (f)(5) (i) or (ii) of this section, if the
laser or operation control can be operated at a separation distance
greater than 2 meters from
[[Page 635]]
any other separately housed portion of the laser product incorporating
an emission indicator.
(iv) Any visible signal required by paragraph (f)(5) (i) or (ii) of
this section shall be clearly visible through protective eyewear
designed specifically for the wavelength(s) of the emitted laser
radiation.
(v) Emission indicators required by paragraph (f)(5) (i) or (ii) of
this section shall be located so that viewing does not require human
exposure to laser or collateral radiation in excess of the accessible
emission limits of Class I and table VI.
(6) Beam attenuator. (i) Each laser system classified as a Class II,
III, or IV laser product shall be provided with one or more permanently
attached means, other than laser energy source switch(es), electrical
supply main connectors, or the key-actuated master control, capable of
preventing access by any part of the human body to all laser and
collateral radiation in excess of the accessible emission limits of
Class I and table VI.
(ii) If the configuration, design, or function of the laser product
would make unnecessary compliance with the requirement in paragraph
(f)(6)(i) of this section, the Director, Office of Compliance (HFZ-300),
Center for Devices and Radiological Health, may, upon written
application by the manufacturer, approve alternate means to accomplish
the radiation protection provided by the beam attenuator.
(7) Location of controls. Each Class IIa, II, III, or IV laser
product shall have operational and adjustment controls located so that
human exposure to laser or collateral radiation in excess of the
accessible emission limits of Class I and table VI is unnecessary for
operation or adjustment of such controls.
(8) Viewing optics. All viewing optics, viewports, and display
screens incorporated into a laser product, regardless of its class,
shall limit the levels of laser and collateral radiation accessible to
the human eye by means of such viewing optics, viewports, or display
screens during operation or maintenance to less than the accessible
emission limits of Class I and table VI. For any shutter or variable
attenuator incorporated into such viewing optics, viewports, or display
screens, a means shall be provided:
(i) To prevent access by the human eye to laser and collateral
radiation in excess of the accessible emission limits of Class I and
table VI whenever the shutter is opened or the attenuator varied.
(ii) To preclude, upon failure of such means as required in
paragraph (f)(8)(i) of this section, opening the shutter or varying the
attenuator when access by the human eye is possible to laser or
collateral radiation in excess of the accessible emission limits of
Class I and table VI.
(9) Scanning safeguard. Laser products that emit accessible scanned
laser radiation shall not, as a result of any failure causing a change
in either scan velocity or amplitude, permit human access to laser
radiation in excess of:
(i) The accessible emission limits of the class of the product, or
(ii) The accessible emission limits of the class of the scanned
laser radiation if the product is Class IIIb or IV and the accessible
emission limits of Class IIIa would be exceeded solely as result of such
failure.
(10) Manual reset mechanism. Each laser system manufactured after
August 20, 1986, and classified as a Class IV laser product shall be
provided with a manual reset to enable resumption of laser radiation
emission after interruption of emission caused by the use of a remote
interlock or after an interruption of emission in excess of 5 seconds
duration due to the unexpected loss of main electrical power.
(g) Labeling requirements. In addition to the requirements of
Secs. 1010.2 and 1010.3, each laser product shall be subject to the
applicable labeling requirements of this paragraph.
(1) Class IIa and II designations and warnings. (i) Each Class IIa
laser product shall have affixed a label bearing the following wording:
``Class IIa Laser Product--Avoid Long-Term Viewing of Direct Laser
Radiation.''
[[Page 636]]
(ii) Each Class II laser product shall have affixed a label bearing
the warning logotype A (figure 1 in this paragraph) and including the
following wording:
[Position I on the logotype]
``LASER RADIATION--DO NOT STARE INTO BEAM''; and
[Position 3 on the logotype]
``CLASS II LASER PRODUCT''.
[GRAPHIC] [TIFF OMITTED] TR01FE93.037
(2) Class IIIa and IIIb designations and warnings. (i) Each Class
IIIa laser product with an irradiance less than or equal to
2.5x10-3 W cm2- shall have affixed a label bearing
the warning logotype A (figure 1 of paragraph (g)(1)(ii) of this
section) and including the following wording:
[Position 1 on the logotype]
``LASER RADIATION--DO NOT STARE INTO BEAM OR VIEW DIRECTLY WITH OPTICAL
INSTRUMENTS''; and,
[Position 3 on the logotype]
``CLASS IIIa LASER PRODUCT''.
(ii) Each Class IIIa laser product with an irradiance greater than
2.5x10-3 W cm-2 shall have affixed a label bearing
the warning logotype B (figure 2 in this
[[Page 637]]
paragraph) and including the following wording:
[Position 1 on the logotype]
``LASER RADIATION--AVOID DIRECT EYE EXPOSURE''; and,
[Position 3 on the logotype]
``CLASS IIIa LASER PRODUCT''.
[GRAPHIC] [TIFF OMITTED] TR01FE93.038
(iii) Each Class IIIb laser product shall have affixed a label
bearing the warning logotype B (figure 2 of paragraph (g)(2)(ii) of this
section) and including the following wording:
[Position 1 on the logotype]
``LASER RADIATION--AVOID DIRECT EXPOSURE TO BEAM''; and,
[Position 3 on the logotype]
``CLASS IIIb LASER PRODUCT''.
(3) Class IV designation and warning. Each Class IV laser product
shall have affixed a label bearing the warning logotype B (figure 2 of
paragraph (g)(2)(ii) of this section), and including the following
wording:
[Position 1 on the logotype]
``LASER RADIATION--AVOID EYE OR SKIN EXPOSURE TO DIRECT OR SCATTERED
RADIATION''; and,
[Position 3 on the logotype]
``CLASS IV LASER PRODUCT''.
(4) Radiation output information on warning logotype. Each Class II,
III, and IV laser product shall state in appropriate units, at position
2 on the required warning logotype, the maximum
[[Page 638]]
output of laser radiation, the pulse duration when appropriate, and the
laser medium or emitted wavelength(s).
(5) Aperture label. Each laser product, except medical laser
products and Class IIa laser products, shall have affixed, in close
proximity to each aperture through which is emitted accessible laser or
collateral radiation in excess of the accessible emission limits of
Class I and table VI of paragraph (d) of this section, a label(s)
bearing the following wording as applicable.
(i) ``AVOID EXPOSURE--Laser radiation is emitted from this
aperture,'' if the radiation emitted through such aperture is laser
radiation.
(ii) ``AVOID EXPOSURE--Hazardous electromagnetic radiation is
emitted from this aperture,'' if the radiation emitted through such
aperture is collateral radiation described in table VI, item 1.
(iii) ``AVOID EXPOSURE--Hazardous x-rays are emitted from this
aperture,'' if the radiation emitted through such aperture is collateral
radiation described in table VI, item 2.
(6) Labels for noninterlocked protective housings. For each laser
product, labels shall be provided for each portion of the protective
housing which has no safety interlock and which is designed to be
displaced or removed during operation, maintenance, or service, and
thereby could permit human access to laser or collateral radiation in
excess of the limits of Class I and table VI. Such labels shall be
visible on the protective housing prior to displacement or removal of
such portion of the protective housing and visible on the product in
close proximity to the opening created by removal or displacement of
such portion of the protective housing, and shall include the wording:
(i) ``CAUTION--Laser radiation when open. DO NOT STARE INTO BEAM.''
for Class II accessible laser radiation.
(ii) ``CAUTION--Laser radiation when open. DO NOT STARE INTO BEAM OR
VIEW DIRECTLY WITH OPTICAL INSTRUMENTS.'' for Class IIIa accessible
laser radiation with an irradiance less than or equal to
2.5x10-3 W cm-2.
(iii) ``DANGER--Laser radiation when open. AVOID DIRECT EYE
EXPOSURE.'' for Class IIIa accessible laser radiation with an irradiance
greater than 2.5x10-3 W cm-2.
(iv) ``DANGER--Laser radiation when open. AVOID DIRECT EXPOSURE TO
BEAM.'' for Class IIIb accessible laser radiation.
(v) ``DANGER--Laser radiation when open. AVOID EYE OR SKIN EXPOSURE
TO DIRECT OR SCATTERED RADIATION.'' for Class IV accessible laser
radiation.
(vi) ``CAUTION--Hazardous electromagnetic radiation when open.'' for
collateral radiation in excess of the accessible emission limits in
table VI, item 1 of paragraph (d) of this section.
(vii) ``CAUTION--Hazardous x-rays when open.'' for collateral
radiation in excess of the accessible emission limits in table VI, item
2 of paragraph (d) of this section.
(7) Labels for defeatably interlocked protective housings. For each
laser product, labels shall be provided for each defeatably interlocked
(as described in paragraph (f)(2)(iv) of this section) portion of the
protective housing which is designed to be displaced or removed during
operation, maintenance, or service, and which upon interlock defeat
could permit human access to laser or collateral radiation in excess of
the limits of Class I or table VI. Such labels shall be visible on the
product prior to and during interlock defeat and in close proximity to
the opening created by the removal or displacement of such portion of
the protective housing, and shall include the wording:
(i) ``CAUTION--Laser radiation when open and interlock defeated. DO
NOT STARE INTO BEAM.'' for Class II accessible laser radiation.
(ii) ``CAUTION--Laser radiation when open and interlock defeated. DO
NOT STARE INTO BEAM OR VIEW DIRECTLY WITH OPTICAL INSTRUMENTS.'' for
Class IIIa accessible laser radiation with an irradiance less than or
equal to 2.5x10-3 W cm-2.
(iii) ``DANGER--Laser radiation when open and interlock defeated.
AVOID DIRECT EYE EXPOSURE.'' for Class IIIa accessible laser radiation
when an irradiance greater than 2.5x10-3 W cm-2.
(iv) ``DANGER--Laser radiation when open and interlock defeated.
AVOID DIRECT EXPOSURE TO
[[Page 639]]
BEAM.'' for Class IIIb accessible laser radiation.
(v) ``DANGER--Laser radiation when open and interlock defeated.
AVOID EYE OR SKIN EXPOSURE TO DIRECT OR SCATTERED RADIATION.'' for Clas
IV accessible laser radiation.
(vi) ``CAUTION--Hazardous electromagnetic radiation when open and
interlock defeated.'' for collateral radiation in excess of the
accessible emission limits in table VI. item 1 of paragraph (d) of this
section.
(vii) ``CAUTION--Hazardous x-rays when open and interlock
defeated.'' for collateral radiation in excess of the accesible emission
limits in table VI. item 2 of paragraph (d) of this section.
(8) Warning for visible and/or invisible radiation. On the labels
specified in this paragraph, if the laser or collateral radiation
referred to is:
(i) Invisible radiation, the word ``invisible'' shall appropriately
precede the word ``radiation''; or
(ii) Visible and invisible radiation, the words ``visible and
invisible'' or ``visible and/or invisible'' shall appropriately precede
the word ``radiation.''
(iii) Visible laser radiation only, the phrase ``laser light'' may
replace the phrase ``laser radiation.''
(9) Positioning of labels. All labels affixed to a laser product
shall be positioned so as to make unnecessary, during reading, human
exposure to laser radiation in excess of the accessible emission limits
of Class I radiation or the limits of collateral radiation established
to table VI of paragraph (d) of this section.
(10) Label specifications. Labels required by this section and
Sec. 1040.11 shall be permanently affixed to, or inscribed on, the laser
product, legible, and clearly visible during operation, maintenance, or
service, as appropriate. If the size, configuration, design, or function
of the laser product would preclude compliance with the requirements for
any required label or would render the required wording of such label
inappropriate or ineffective, the Director, Office of Compliance (HFZ-
300), Center for Devices and Radiological Health, on the Director's own
initiative or upon written application by the manufacturer, may approve
alternate means of providing such label(s) or alternate wording for such
label(s) as applicable.
(h) Informational requirements--(1) User information. Manufacturers
of laser products shall provide as an integral part of any user
instruction or operation manual which is regularly supplied with the
product, or, if not so supplied, shall cause to be provided with each
laser product:
(i) Adequate instructions for assembly, operation, and maintenance,
including clear warnings concerning precautions to avoid possible
exposure to laser and collateral radiation in excess of the accessible
emission limits in tables I, II-A, II, III-A, III-B, and VI of paragraph
(d) of this section, and a schedule of maintenance necessary to keep the
product in compliance with this section and Sec. 1040.11.
(ii) A statement of the magnitude, in appropriate units, of the
pulse durations(s), maximum radiant power and, where applicable, the
maximum radiant energy per pulse of the accessible laser radiation
detectable in each direction in excess of the accessible emission limits
in table I of paragraph (d) of this section determined under paragraph
(e) of this section.
(iii) Legible reproductions (color optional) of all labels and
hazard warnings required by paragraph (g) of this section and
Sec. 1040.11 to be affixed to the laser product or provided with the
laser product, including the information required for positions 1, 2,
and 3 of the applicable logotype (figure 1 of paragraph (g)(1)(ii) or
figure 2 or paragraph (g)(2)(ii) of this section). The corresponding
position of each label affixed to the product shall be indicated or, if
provided with the product, a statement that such labels could not be
affixed to the product but were supplied with the product and a
statement of the form and manner in which they were supplied shall be
provided.
(iv) A listing of all controls, adjustments, and procedures for
operation and maintenance, including the warning ``Caution--use of
controls or adjustments or performance of procedures other than those
specified herein may result in hazardous radiation exposure.''
(v) In the case of laser products other than laser systems, a
statment of the
[[Page 640]]
compatibility requirements for a laser energy source that will assure
compliance of the laser product with this section and Sec. 1040.11.
(vi) In the case of laser products classified with a 7 millimeter
diameter aperture stop as provided in paragraph (e)(3)(i) of this
section, if the use of a 50 millimeter diameter aperture stop would
result in a higher clsssification of the product, the following warning
shall be included in the user information: ``CAUTION--The use of optical
instruments with this product will increase eye hazard.''
(2) Purchasing and servicing information. Manufacturers of laser
products shall provide or cause to be provided:
(i) In all catalogs, specification sheets, and descriptive brochures
pertaining to each laser product, a legible reproduction (color
optional) of the class designation and warning required by paragraph (g)
of this section to be affixed to that product, including the information
required for positions 1, 2, and 3 of the applicable logotype (figure 1
of paragraph (g)(1)(ii) or figure 2 of paragraph (g)(2)(ii) of this
section).
(ii) To servicing dealers and distributors and to others upon
request at a cost not to exceed the cost of preparation and
distribution, adequate instructions for service adjustments and service
procedures for each laser product model, including clear warnings and
precautions to be taken to avoid possible exposure to laser and
collateral radiation in excess of the accessible emission limits in
tables I, II-A, II, III-A, III-B, and VI of paragraph (d) of this
section, and a schedule of maintenance necessary to keep the product in
compliance with this section and Sec. 1040.11; and in all such service
instructions, a listing of those controls and procedures that could be
utilized by persons other than the manufacturers or the manufacturer's
agents to increase accessible emission levels of radiation and a clear
description of the location of displaceable portions of the protective
housing that could allow human access to laser or collateral radiation
in excess of the accessible emission limits in tables I, II-A, II, III-
A, III-B, and VI of paragraph (d) of this section. The instructions
shall include protective procedures for service personnel to avoid
exposure to levels of laser and collateral radiation known to be
hazardous for each procedure or sequence of procedures to be
accomplished, and legible reproductions (color optional) of required
labels and hazard warnings.
(i) Modification of a certified product. The modification of a laser
product, previously certified under Sec. 1010.2, by any person engaged
in the business of manufacturing, assembling, or modifying laser
products shall be construed as manufacturing under the act if the
modification affects any aspect of the product's performance or intended
function(s) for which this section and Sec. 1040.11 have an applicable
requirement. The manufacturer who performs such modification shall
recertify and reidentify the product in accordance with the provisions
of Secs. 1010.2. and 1010.3.
(The information collection requirements contained in paragraph
(a)(3)(ii) were approved by the Office of Management and Budget under
control number 0910-0176)
[50 FR 33688, Aug. 20, 1985; 50 FR 42156, Oct. 18, 1985; 65 FR 17138,
Mar. 31, 2000]