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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2013]
[CITE: 21CFR1040.10]
See Related Information on Laser products. in CDRH databases



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER J--RADIOLOGICAL HEALTH

PART 1040 -- PERFORMANCE STANDARDS FOR LIGHT-EMITTING PRODUCTS

Sec. 1040.10 Laser products.

(a)Applicability. The provisions of this section and 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 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 Food and Drug Administration, Center for Devices and Radiological Health, Director, Office of Compliance, 10903 New Hampshire Ave., Bldg. 66, rm. 3521, Silver Spring, MD 20993-0002.

(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 1002.31.

(b)Definitions. As used in this section and 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 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

(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

(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

(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

(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

(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

(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 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-2sr-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*106nm (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 1.0*106nm 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 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-2sr-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 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,k 1andk 2vary 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.

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(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.

(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 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 1010.13, tests for compliance with each of the applicable requirements of this section and 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*10-3steradian 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-2equivalent 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**10-3steradian with collimating optics of 5 diopters or less, divided by the area of the aperture stop (cm-2).

(iii) The radiance (W cm-2sr-1) or integrated radiance (J cm-2sr-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*10-5steradian 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 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 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 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."

(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".

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(2)Class IIIa and IIIb designations and warnings. (i) Each Class IIIa laser product with an irradiance less than or equal to 2.5*10-3W 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*10-3W cm-2shall have affixed a label bearing the warning logotype B (figure 2 in this 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".

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(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 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*10-3W 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*10-3W 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*10-3W 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*10-3W cm-2.

(iv) "DANGER--Laser radiation when open and interlock defeated. AVOID DIRECT EXPOSURE TO 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 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 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 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 compatibility requirements for a laser energy source that will assure compliance of the laser product with this section and 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 classification 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 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 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 1040.11 have an applicable requirement. The manufacturer who performs such modification shall recertify and reidentify the product in accordance with the provisions of 1010.2. and 1010.3.

1Class I levels of laser radiation are not considered to be hazardous.

2Class IIa levels of laser radiation are not considered to be hazardous if viewed for any period of time less than or equal to 1*103seconds but are considered to be a chronic viewing hazard for any period of time greater than 1*103seconds.

3Class II levels of laser radiation are considered to be a chronic viewing hazard.

4Class 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.

5Class IIIb levels of laser radiation are considered to be an acute hazard to the skin and eyes from direct radiation.

6Class IV levels of laser radiation are considered to be an acute hazard to the skin and eyes from direct and scattered radiation.

(1) The factorsk 1andk 2are wavelength-dependent correction factors determined from table IV.

(2) The variablet in the expressions of emission limits is the magnitude of the sampling interval in units of seconds.

Notes applicable to tables I, II-A, II, III-A and III-B:

[50 FR 33688, Aug. 20, 1985; 50 FR 42156, Oct. 18, 1985; 65 FR 17138, Mar. 31, 2000, as amended at 75 FR 20917, Apr. 22, 2010]

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