21 CFR 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 Director, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, 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.

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

(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.

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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 × 10

3 seconds but are considered to be a chronic viewing hazard for any period of time greater than 1 × 10

3 seconds.

(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.

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

(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.

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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.

(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.

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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.

(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.

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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.

(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−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 × 10

6 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 1.0 × 10

6 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 § 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 § 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.

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.

(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 × 10−3 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 × × 10−3 steradian with collimating optics of 5 diopters or less, divided by the area of the