[Title 21 CFR 1040.10]
[Code of Federal Regulations (annual edition) - April 1, 1999 Edition]
[Title 21 - FOOD AND DRUGS]
[Chapter I - FOOD AND DRUG ADMINISTRATION,]
[Subchapter J - RADIOLOGICAL HEALTH]
[Part 1040 - PERFORMANCE STANDARDS FOR LIGHT-EMITTING PRODUCTS]
[Sec. 1040.10 - Laser products.]
[From the U.S. Government Printing Office]


21FOOD AND DRUGS81999-04-011999-04-01falseLaser products.1040.10Sec. 1040.10FOOD AND DRUGSFOOD AND DRUG ADMINISTRATION,RADIOLOGICAL HEALTHPERFORMANCE STANDARDS FOR LIGHT-EMITTING PRODUCTS
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). The registration and listing shall 
include the name and address of the manufacturer and shall be submitted 
to the Director, Office of Compliance (HFZ-300), Center for Devices and 
Radiological Health, 5600 Fishers Lane, Rockville, MD 20857.
    (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:

[[Page 597]]

    (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 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

[[Page 598]]

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 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

[[Page 599]]

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-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.

[[Page 600]]

Accessible emission limits for collateral radiation are specified in 
table VI of this paragraph.

        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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[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 607]]

    (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 608]]

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 609]]

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 610]]

    (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 
2.5 x 10-3 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 
2.5 x 10-3 W cm-2 shall have affixed a label 
bearing the warning logotype B (figure 2 in this

[[Page 611]]

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 612]]

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 
2.5 x 10-3 W cm-2.
    (iii) ``DANGER--Laser radiation when open. AVOID DIRECT EYE 
EXPOSURE.'' for Class IIIa accessible laser radiation with an irradiance 
greater than 2.5 x 10-3 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 2.5 x 10-3 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 2.5 x 10-3 W cm-2.
    (iv) ``DANGER--Laser radiation when open and interlock defeated. 
AVOID DIRECT EXPOSURE TO

[[Page 613]]

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 614]]

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]