How To Register Class Iiia Laser With Fda

[Code of Federal Regulations]

[Title 21, Book 8]

[CITE: 21CFR1040.10]

See Related Information on Laser products. in CDRH databases

CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF Wellness AND Human SERVICES

SUBCHAPTER J - RADIOLOGICAL Wellness

Sec. 1040.ten Laser products.

(a) Applicability. The provisions of this section and § 1040.11, as amended, are applicative equally specified to all laser products manufactured or assembled after August ane, 1976, except when:

(1) Such a light amplification by stimulated emission of radiation production is either sold to a manufacturer of an electronic product for use as a component (or replacement) in such electronic product, or

(ii) Sold by or for a manufacturer of an electronic production for employ as a component (or replacement) in such electronic product, provided that such laser product:

(i) Is accompanied by a general alert notice that adequate instructions for the safe installation of the laser production are provided in servicing information available from the consummate light amplification by stimulated emission of radiation product manufacturer nether paragraph (h)(2)(ii) of this department, and should exist followed,

(ii) Is labeled with a argument that information technology is designated for utilize solely as a component of such electronic product and therefore does non comply with the advisable requirements of this section and § 1040.xi for complete laser products, and

(3) Is not a removable laser system as described in paragraph (c)(two) 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 proper noun, model number, and laser medium or emitted wavelength(s), and the proper noun and address of the manufacturer. The manufacturer must submit the registration and list to the Director, Center for Devices and Radiological Health, Nutrient and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Silver Spring, MD 20993-0002.

(ii) Maintains and allows access to whatever sales, shipping, or distribution records that identify the purchaser of such a laser product by proper name and address, the product by blazon, the number of units sold, and the date of auction (shipment). These records shall be maintained and made bachelor equally specified in § 1002.31.

(b) Definitions. As used in this section and § 1040.eleven, the following definitions apply:

(ane) Accessible emission level ways the magnitude of accessible light amplification by stimulated emission of radiation or collateral radiations of a specific wavelength and emission duration at a detail indicate equally measured according to paragraph (e) of this department. Accessible laser or collateral radiation is radiation to which human access is possible, as defined in paragraphs (b) (12), (fifteen), and (22) of this section.

(ii) Accessible emission limit ways the maximum accessible emission level permitted inside a particular grade as set forth in paragraphs (c), (d), and (e) of this section.

(iii) Aperture ways any opening in the protective housing or other enclosure of a light amplification by stimulated emission of radiation product through which laser or collateral radiation is emitted, thereby allowing human admission to such radiations.

(4) Discontinuity stop means an opening serving to limit the size and to define the shape of the area over which radiation is measured.

(five) Class I light amplification by stimulated emission of radiation product means whatever laser product that does not permit access during the functioning to levels of laser radiation in excess of the accessible emission limits independent in table I of paragraph (d) of this section. ¹

(half-dozen) Class IIa laser product means whatsoever laser product that permits human access during operation to levels of visible light amplification by stimulated emission of radiation radiation in backlog of the accessible emission limits contained in table I, only does not allow human access during operation to levels of laser radiation in excess of the attainable emission limits contained in table Ii-A of paragraph (d) of this section. ⁱⁱ

(7) Class II laser production means whatever laser product that permits human admission during performance to levels of visible light amplification by stimulated emission of radiation radiations in backlog of the attainable emission limits independent in table Two-A, but does not permit human access during operation to levels of laser radiations in excess of the accessible emission limits contained in table Two of paragraph (d) of this section. ³

(8) Class IIIa light amplification by stimulated emission of radiation product ways whatsoever laser product that permits human admission during functioning to levels of visible laser radiation in excess of the attainable emission limits contained in table 2, simply does not permit human being access during operation to levels of light amplification by stimulated emission of radiation radiation in excess of the attainable emission limits independent in table III-A of paragraph (d) of this department. ⁴

(ix) Class IIIb light amplification by stimulated emission of radiation product means any laser production 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 allow human admission during performance to levels of laser radiation in backlog of the attainable emission limits contained in tabular array III-B of paragraph (d) of this section. ^v

(10) Course III laser product means any Class IIIa or Class IIIb laser product.

(11) Grade Iv light amplification by stimulated emission of radiation production means any laser that permits human being access during operation to levels of light amplification by stimulated emission of radiation radiations in excess of the accessible emission limits contained in table III-B of paragraph (d) of this department. ⁶

(12) Collateral radiations means any electronic production radiations, except laser radiation, emitted by a light amplification by stimulated emission of radiation production equally a result of the operation of the laser (south) or any component of the laser production that is physically necessary for the operation of the light amplification by stimulated emission of radiation (s).

(13) Sit-in laser product ways any laser product manufactured, designed, intended, or promoted for purposes of demonstration, amusement, advertising display, or artistic limerick. The term "demonstration laser product" does non 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 elapsing of a pulse, a series of pulses, or continuous operation, expressed in seconds, during which man admission to laser or collateral radiations could be permitted as a issue of operation, maintenance, or service of a laser production.

(15) Human being access means the capacity to intercept laser or collateral radiations by any part of the human being torso. For light amplification by stimulated emission of radiation products that contain Class IIIb or IV levels of laser radiation, "human admission" also means access to laser radiation that can be reflected straight by any single introduced flat surface from the interior of the production through any opening in the protective housing of the production.

(sixteen) Integrated radiance ways radiant free energy per unit area of a radiating surface per unit solid angle of emission, expressed in joules per square centimeter per steradian (Jcmâ??2 srâ??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 just less than or equal to 1.0 * 10 ^vi nm (one millimeter).

(18) Irradiance ways the time-averaged radiant ability incident on an element of a surface divided past the area of that element, expressed in watts per square centimeter (Westward cmâ??2).

(19) light amplification by stimulated emission of radiation means any device that can exist made to produce or amplify electromagnetic radiation at wavelenghts greater than 250 nm but less than or equal to 13,000 nm or, later August twenty, 1986, at wavelengths equal to or greater than 180 nm simply less than or equal to one.0 * 10 ^six nm primarily by the process of controlled stimulated emission.

(20) light amplification by stimulated emission of radiation energy source means whatever device intended for use in conjunction with a laser to supply energy for the performance of the light amplification by stimulated emission of radiation . General energy sources such every bit electrical supply mains or batteries shall not be considered to constitute laser free energy sources.

(21) light amplification by stimulated emission of radiation product means any manufactured production or aggregation of components which constitutes, incorporates, or is intended to comprise 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) light amplification by stimulated emission of radiation radiations means all electromagnetic radiation emitted past a laser production inside the spectral range specified in paragraph (b)(19) of this section that is produced as a event of controlled stimulated emission or that is detectable with radiation so produced through the advisable discontinuity stop and within the appropriate solid angle of credence, as specified in paragraph (e) of this department.

(23) laser system means a light amplification by stimulated emission of radiation in combination with an advisable laser energy source with or without additional incorporated components. See paragraph (c)(2) of this department 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 past the user for the purpose of assuring the intended functioning of the product. It does not include functioning 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 attainable laser radiations emitted by a laser production during operation, every bit adamant under paragraph (e) of this section.

(26) Medical laser product means whatever laser production which is a medical device every bit defined in 21 U.s.C. 321(h) and is manufactured, designed, intended or promoted for in vivo laser irradiation of whatever function of the human torso for the purpose of: (i) Diagnosis, surgery, or therapy; or (ii) relative positioning of the human body.

(27) Operation means the performance of the light amplification by stimulated emission of radiation product over the full range of its functions. Information technology does non include maintenance or service as defined in paragraphs (b) (24) and (38) of this section.

(28) Protective housing means those portions of a laser production which are designed to prevent human being access to laser or collateral radiation in excess of the prescribed attainable emission limits nether weather specified in this section and in § 1040.xi.

(29) Pulse elapsing means the time increment measured between the half-height-ability points at the leading and trailing edges of a pulse.

(30) Radiance means time-averaged radiant power per unit of measurement area of a radiating surface per unit solid angle of emission, expressed in watts per foursquare centimeter per steradian (W cmâ??2 srâ??ane).

(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 chemical element of a surface divided by the area of the chemical element, expressed in joules per square centimeter (Jcmâ??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 electric connector which permits the connectedness of external remote interlocks.

(35) Prophylactic interlock means a device associated with the protective housing of a laser product to prevent human access to excessive radiations in accord with paragraph (f)(two) of this section.

(36) Sampling interval ways the time interval during which the level of accessible laser or collateral radiation is sampled past a measurement process. The magnitude of the sampling interval in units of seconds is represented by the symbol (t ).

(37) Scanned laser radiations ways laser radiation having a fourth dimension-varying management, origin or pattern of propagation with respect to a stationary frame of reference.

(38) Service means the functioning of those procedures or adjustments described in the manufacturer's service instructions which may impact whatever aspect of the product'south functioning for which this section and § 1040.xi have applicable requirements. Information technology does not include maintenance or operation as defined in paragraphs (b) (24) and (27) of this section.

(39) Surveying, leveling, or alignment light amplification by stimulated emission of radiation production means a laser product manufactured, designed, intended or promoted for i or more of the following uses:

(i) Determining and delineating the grade, extent, or position of a point, body, or area by taking angular measurement.

(two) Positioning or adjusting parts in proper relation to one another.

(iii) Defining a plane, level, elevation, or directly line.

(40) Visible radiation means light amplification by stimulated emission of radiation or collateral radiations having wavelengths of greater than 400 nm but less than or equal to 710 nm.

(41) Alert logotype ways a logotype as illustrated in either figure 1 or figure 2 of paragraph (yard) of this section.

(42) Wavelength ways the propagation wavelength in air of electromagnetic radiations.

(c) Classification of laser products - (one) All laser products. Each laser product shall exist classified in Class I, IIa, Two, IIIa, IIIb, or IV in accordance with definitions set forth in paragraphs (b) (5) through (eleven) of this department. The production classification shall exist based on the highest attainable emission level(southward) of laser radiation to which human access is possible during operation in accordance with paragraphs (d), (e), and (f)(i) of this section.

(2) Removable laser systems. Whatever laser system that is incorporated into a light amplification by stimulated emission of radiation 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 exist considered a laser product and shall be separately subject to the applicative requirements in this subchapter for laser products of its class. It shall exist classified on the basis of accessible emission of laser radiation when so removed.

(d) Accessible emission limits. Accessible emission limits for laser radiations in each course are specified in tables I, II-A, II, III-A, and 3-B of this paragraph. The factors, k ane and k two vary with wavelength and emission duration. These factors are given in table Four of this paragraph, with selected numerical values in table V of this paragraph. Accessible emission limits for collateral radiation are specified in tabular array Half dozen of this paragraph.

(1) Beam of a single wavelength. laser or collateral radiation of a single wavelength exceeds the attainable emission limits of a class if its attainable emission level is greater than the attainable emission limit of that class within any of the ranges of emission elapsing specified in tables I, Two-A, II, 3-A, and 3-B of this paragraph.

(2) Beam of multiple wavelengths in aforementioned range. laser or collateral radiation having ii 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 attainable emission limits of a grade 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 elapsing and wavelength distribution which results in the maximum sum.

(three) 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 information technology exceeds the applicable limits within whatsoever one of those wavelength ranges. This determination is made for each wavelength range in accord with paragraph (d) (1) or (2) of this department.

(4) Class I dual limits. laser or collateral radiations in the wavelength range of greater than 400 nm but less than or equal to i.400 nm exceeds the attainable emission limits of Class I if it exceeds both:

(i) The Class I accessible emission limits for radiant free energy inside any range of emission duration specified in table I of this paragraph, and

(ii) The Class I accessible emission limits for integrated radiance inside 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 business relationship 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 business relationship for increases in emission and degradation in radiation prophylactic with age.

(two) Test conditions. Except as provided in § 1010.thirteen, tests for compliance with each of the applicable requirements of this section and § 1040.xi shall be made during operation, maintenance, or service as advisable:

(i) Under those weather and procedures which maximize the attainable emission levels, including start-up, stabilized emission, and shut-down of the laser production; and

(2) With all controls and adjustments listed in the operation, maintenance, and service instructions adjusted in combination to outcome in the maximum attainable emission level of radiation; and

(iii) At points in space to which human access is possible in the production configuration which is necessary to decide compliance with each requirement, eastward.g., if performance may require removal of portions of the protective housing and defeat of prophylactic interlocks, measurements shall exist made at points accessible in that product configuration; and

(iv) With the measuring instrument detector and then positioned and and then oriented with respect to the laser production as to result in the maximum detection of radiation by the instrument; and

(v) For a laser product other than a laser organisation, with the laser coupled to that type of laser energy source which is specified as compatible by the light amplification by stimulated emission of radiation 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 exist used in a locale where the emitted laser radiation is unlikely to exist viewed with optical instruments, the radiant power (Due west) or radiant energy (J) detectable through a circular aperture cease having a diameter of 7 millimeters and inside a circular solid angle of acceptance of one * 10â??3 steradian with collimating eyes of 5 diopters or less. For scanned laser radiation, the direction of the solid angle of acceptance shall change equally needed to maximize detectable radiation, with an athwart speed of upwardly to v radians/2d. A l millimeter diameter aperture stop with the aforementioned collimating optics and credence angle stated above shall be used for all other laser products (except that a seven millimeter diameter aperture stop shall exist used in the measurement of scanned laser radiation emitted past laser products manufactured on or earlier August 20, 1986.

(2) The irradiance (W cmâ??ii) or radiant exposure (J cmâ??two equivalent to the radiant power (W) or radiant free energy (J) detectable through a round aperture stop having a diameter of 7 millimeters and, for irradiance, inside a circular solid angle of acceptance of 1 * * 10â??iii steradian with collimating optics of 5 diopters or less, divided by the area of the aperture cease (cmâ??two).

(iii) The radiance (West cmâ??two srâ??1) or integrated radiance (J cmâ??2 srâ??ane) equivalent to the radiant power (West) or radiant free energy (J) detectable through a circular aperture stop having a diameter of 7 millimeters and inside a circular solid angle of credence of 1 * 10â??5 steradian with collimating optics of 5 diopters or less, divided by that solid bending (sr) and by the surface area of the discontinuity stop (cmâ??ii).

(f) Performance requirements - (1) Protective housing. Each laser product shall take a protective housing that prevents human being access during operation to laser and collateral radiations that exceed the limits of Class I and table 6, respectively, wherever and whenever such human access is not necessary for the product to perform its intended part. Wherever and whenever human access to laser radiation levels that exceed the limits of Grade I is necessary, these levels shall non exceed the limits of the lowest class necessary to perform the intended part(s) of the production.

(2) Safety interlocks. (i) Each laser production, regardless of its form, shall be provided with at least one prophylactic 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(due south), human being access to light amplification by stimulated emission of radiation or collateral radiation in backlog of the accessible emission limit applicative nether paragraph (f)(one) of this section.

(two) Each required prophylactic 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 foreclose removal or displacement of the interlocked portion of the protective housing shall exist provided, if failure of a unmarried interlock would allow;

(a ) Human access to a level of laser radiations in excess of the accessible emission limits of Form IIIa; or

(b ) laser radiation in backlog of the accessible emission limits of Form 2 to be emitted directly through the opening created by removal or displacement of the interlocked portion of the protective housing.

(iv) laser products that comprise rubber interlocks designed to allow rubber interlock defeat shall incorporate a ways of visual or aural indication of interlock defeat. During interlock defeat, such indication shall exist visible or audible whenever the laser product is energized, with and without the associated portion of the protective housing removed or displaced.

(five) Replacement of a removed or displaced portion of the protective housing shall not exist possible while required safety interlocks are defeated.

(3) Remote interlock connector. Each laser arrangement classified every bit a Form IIIb or Four laser product shall comprise a readily available remote interlock connector having an electric potential difference of no greater than 130 root-mean-foursquare volts between terminals. When the terminals of the connector are not electrically joined, human admission to all light amplification by stimulated emission of radiation and collateral radiations from the laser product in excess of the accessible emission limits of Form I and tabular array Six shall exist prevented.

(4) Key control. Each laser system classified every bit a Class IIIb or IV laser product shall incorporate a key-actuated primary control. The key shall be removable and the laser shall non be operable when the primal is removed.

(5) laser radiation emission indicator. (i) Each light amplification by stimulated emission of radiation system classified every bit a Class II or IIIa laser product shall incorporate an emission indicator that provides a visible or audible signal during emission of attainable light amplification by stimulated emission of radiation radiations in excess of the accessible emission limits of Form I.

(ii) Each laser system classified equally a Class IIIb or Four laser production shall incorporate an emission indicator which provides a visible or audible indicate during emission of accessible laser radiation in backlog of the accessible emission limits of Class I, and sufficiently prior to emission of such radiation to allow advisable action to avoid exposure to the light amplification by stimulated emission of radiation radiation.

(3) For laser systems manufactured on or before August xx, 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 (2) of this section. For laser systems manufactured afterward August twenty, 1986, each separately housed laser and performance 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 performance control tin be operated at a separation distance greater than 2 meters from any other separately housed portion of the light amplification by stimulated emission of radiation product incorporating an emission indicator.

(iv) Any visible signal required by paragraph (f)(5) (i) or (two) of this department shall be clearly visible through protective eyewear designed specifically for the wavelength(s) of the emitted laser radiations.

(v) Emission indicators required past paragraph (f)(5) (i) or (ii) of this department shall be located then that viewing does not require human exposure to laser or collateral radiation in excess of the accessible emission limits of Course I and table VI.

(six) Axle attenuator. (i) Each laser system classified as a Form 2, III, or IV laser product shall be provided with 1 or more permanently attached means, other than light amplification by stimulated emission of radiation energy source switch(es), electrical supply primary connectors, or the key-actuated primary control, capable of preventing access by whatsoever role of the human body to all laser and collateral radiation in excess of the accessible emission limits of Class I and tabular array VI.

(two) If the configuration, pattern, or function of the laser product would make unnecessary compliance with the requirement in paragraph (f)(6)(i) of this section, the Manager, Middle for Devices and Radiological Health, may, upon written awarding by the manufacturer, approve alternate means to accomplish the radiation protection provided by the beam attenuator.

(seven) Location of controls. Each Form IIa, II, III, or IV laser product shall take operational and adjustment controls located so that man exposure to laser or collateral radiation in excess of the accessible emission limits of Class I and table Half dozen is unnecessary for performance or aligning of such controls.

(8) Viewing optics. All viewing optics, viewports, and brandish screens incorporated into a laser product, regardless of its class, shall limit the levels of laser and collateral radiation accessible to the homo centre by means of such viewing eyes, viewports, or display screens during functioning or maintenance to less than the accessible emission limits of Class I and table Six. For whatever shutter or variable attenuator incorporated into such viewing optics, viewports, or display screens, a ways shall be provided:

(i) To prevent access past the human heart 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 department, 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 Course I and table Six.

(9) Scanning safeguard. laser products that emit attainable scanned laser radiations shall not, as a outcome of any failure causing a change in either browse velocity or amplitude, permit homo access to laser radiation in excess of:

(i) The attainable emission limits of the grade of the product, or

(two) The accessible emission limits of the grade of the scanned light amplification by stimulated emission of radiation radiation if the product is Course IIIb or 4 and the accessible emission limits of Grade IIIa would be exceeded solely as result of such failure.

(10) Manual reset mechanism. Each light amplification by stimulated emission of radiation system manufactured after August 20, 1986, and classified as a Class Four laser product shall be provided with a manual reset to enable resumption of laser radiations emission subsequently interruption of emission caused by the apply of a remote interlock or after an pause of emission in excess of 5 seconds duration due to the unexpected loss of main electrical power.

(yard) Labeling requirements. In addition to the requirements of §§ 1010.ii and 1010.3, each laser product shall be discipline to the applicable labeling requirements of this paragraph.

(1) Form IIa and Two designations and warnings. (i) Each Grade IIa laser product shall take affixed a label bearing the following diction: "Course IIa laser Product - Avoid Long-Term Viewing of Direct light amplification by stimulated emission of radiation Radiation."

(two) Each Course 2 laser product shall accept affixed a label bearing the alarm logotype A (effigy 1 in this paragraph) and including the following wording:

[Position I on the logotype]

" laser Radiations - Practice Non STARE INTO BEAM"; and

[Position 3 on the logotype]

"Class 2 laser PRODUCT".

(2) Grade IIIa and IIIb designations and warnings. (i) Each Class IIIa laser product with an irradiance less than or equal to 2.5 * 10â??3 W cm2â?? shall take affixed a label bearing the alarm logotype A (figure one of paragraph (thousand)(one)(ii) of this section) and including the following wording:

[Position 1 on the logotype]

" laser RADIATION - Do Non STARE INTO BEAM OR VIEW DIRECTLY WITH OPTICAL INSTRUMENTS"; and,

[Position 3 on the logotype]

"CLASS IIIa laser PRODUCT".

(ii) Each Class IIIa light amplification by stimulated emission of radiation product with an irradiance greater than ii.5 * 10â??3 W cmâ??ii shall have affixed a label begetting the alarm logotype B (figure 2 in this paragraph) and including the post-obit wording:

[Position 1 on the logotype]

" laser RADIATION - AVOID DIRECT Eye EXPOSURE"; and,

[Position 3 on the logotype]

"Class IIIa laser Production".

(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 diction:

[Position 1 on the logotype]

" light amplification by stimulated emission of radiation RADIATION - Avert Direct EXPOSURE TO Beam"; and,

[Position 3 on the logotype]

"CLASS IIIb light amplification by stimulated emission of radiation PRODUCT".

(3) Grade Iv designation and alert. Each Class IV light amplification by stimulated emission of radiation product shall accept affixed a characterization bearing the alert logotype B (effigy 2 of paragraph (thousand)(ii)(ii) of this section), and including the following wording:

[Position 1 on the logotype]

" laser RADIATION - AVOID Centre OR SKIN EXPOSURE TO DIRECT OR SCATTERED Radiation"; and,

[Position 3 on the logotype]

"Course 4 laser Product".

(iv) Radiation output information on warning logotype. Each Class Two, 3, and IV light amplification by stimulated emission of radiation production shall state in appropriate units, at position 2 on the required warning logotype, the maximum output of light amplification by stimulated emission of radiation radiation, the pulse duration when appropriate, and the laser medium or emitted wavelength(due south).

(five) Discontinuity label. Each laser production, except medical laser products and Grade 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(south) begetting the following diction as applicable.

(i) "Avert EXPOSURE - laser radiation is emitted from this aperture," if the radiations emitted through such aperture is laser radiation.

(two) "AVOID EXPOSURE - Hazardous electromagnetic radiation is emitted from this aperture," if the radiation emitted through such discontinuity is collateral radiation described in table VI, item 1.

(iii) "AVOID EXPOSURE - Chancy x-rays are emitted from this discontinuity," if the radiation emitted through such aperture is collateral radiation described in table Half-dozen, item 2.

(6) Labels for noninterlocked protective housings. For each laser production, 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 allow human admission to laser or collateral radiations in backlog of the limits of Class I and tabular array VI. Such labels shall exist 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 past removal or deportation 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. Practise Not STARE INTO BEAM OR VIEW Straight WITH OPTICAL INSTRUMENTS." for Course IIIa attainable laser radiation with an irradiance less than or equal to 2.5 * 10â??3 W cmâ??2.

(iii) "DANGER - laser radiation when open. AVOID DIRECT Centre EXPOSURE." for Class IIIa accessible laser radiations with an irradiance greater than 2.5 * 10â??3 W cmâ??two.

(iv) "DANGER - laser radiation when open. Avert DIRECT EXPOSURE TO BEAM." for Grade IIIb accessible laser radiation.

(5) "DANGER - laser radiation when open up. AVOID Heart OR SKIN EXPOSURE TO DIRECT OR SCATTERED RADIATION." for Class IV attainable light amplification by stimulated emission of radiation radiation.

(vi) "Circumspection - Hazardous electromagnetic radiations when open." for collateral radiation in excess of the accessible emission limits in table VI, detail 1 of paragraph (d) of this section.

(seven) "CAUTION - Hazardous x-rays when open up." for collateral radiation in backlog of the accessible emission limits in table Half dozen, item two 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 admission to laser or collateral radiation in backlog of the limits of Course I or table VI. Such labels shall be visible on the product prior to and during interlock defeat and in shut proximity to the opening created by the removal or displacement of such portion of the protective housing, and shall include the wording:

(i) "Circumspection - laser radiation when open and interlock defeated. Do Not STARE INTO BEAM." for Class Two attainable laser radiation.

(ii) "Circumspection - light amplification by stimulated emission of radiation radiations when open up and interlock defeated. Practise 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.v * 10â??three Westward cmâ??2.

(three) "DANGER - laser radiation when open up and interlock defeated. AVOID Directly Heart EXPOSURE." for Class IIIa accessible light amplification by stimulated emission of radiation radiations when an irradiance greater than 2.5 * 10â??3 W cmâ??2.

(iv) "DANGER - laser radiation when open and interlock defeated. Avert DIRECT EXPOSURE TO BEAM." for Class IIIb accessible laser radiation.

(v) "DANGER - laser radiations when open up and interlock defeated. Avert 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 tabular array VI. item 1 of paragraph (d) of this section.

(seven) "Caution - Chancy ten-rays when open and interlock defeated." for collateral radiation in excess of the accesible emission limits in table VI. item two 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 radiations referred to is:

(i) Invisible radiation, the discussion "invisible" shall accordingly 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 radiations only, the phrase " laser light" may supplant the phrase " light amplification by stimulated emission of radiation radiations."

(ix) Positioning of labels. All labels affixed to a laser product shall be positioned and so as to make unnecessary, during reading, homo exposure to laser radiation in excess of the attainable emission limits of Class I radiation or the limits of collateral radiation established to table VI of paragraph (d) of this section.

(10) Characterization specifications. Labels required by this department and § 1040.11 shall be permanently affixed to, or inscribed on, the laser product, legible, and conspicuously visible during operation, maintenance, or service, as advisable. If the size, configuration, design, or function of the light amplification by stimulated emission of radiation product would preclude compliance with the requirements for any required label or would return the required wording of such label inappropriate or ineffective, the Director, Center for Devices and Radiological Health, on the Director'south own initiative or upon written awarding by the manufacturer, may approve alternate means of providing such characterization(southward) or alternate wording for such characterization(s) as applicable.

(h) Advisory requirements - (i) User information. Manufacturers of light amplification by stimulated emission of radiation products shall provide as an integral part of any user didactics or operation transmission which is regularly supplied with the production, or, if not so supplied, shall cause to be provided with each light amplification by stimulated emission of radiation product:

(i) Adequate instructions for assembly, operation, and maintenance, including articulate warnings concerning precautions to avoid possible exposure to laser and collateral radiation in backlog of the attainable 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 advisable units, of the pulse durations(due south), maximum radiant power and, where applicable, the maximum radiant energy per pulse of the attainable laser radiation detectable in each direction in excess of the attainable emission limits in table I of paragraph (d) of this department determined under paragraph (eastward) of this section.

(three) Legible reproductions (color optional) of all labels and hazard warnings required by paragraph (g) of this department and § 1040.eleven to be affixed to the laser production 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 (thou)(2)(ii) of this section). The respective 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 production only were supplied with the product and a statement of the class 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 alert "Caution - use of controls or adjustments or performance of procedures other than those specified herein may consequence in chancy radiations 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 department and § 1040.11.

(6) 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 l millimeter diameter discontinuity stop would outcome in a higher classification of the product, the following warning shall exist included in the user information: "CAUTION - The utilise of optical instruments with this product will increment middle hazard."

(2) Purchasing and servicing data. Manufacturers of laser products shall provide or cause to exist provided:

(i) In all catalogs, specification sheets, and descriptive brochures pertaining to each light amplification by stimulated emission of radiation product, a legible reproduction (color optional) of the class designation and warning required by paragraph (one thousand) of this section to be affixed to that product, including the data required for positions 1, two, and 3 of the applicable logotype (figure 1 of paragraph (m)(1)(ii) or figure two of paragraph (g)(2)(two) of this section).

(2) To servicing dealers and distributors and to others upon request at a cost not to exceed the price of preparation and distribution, acceptable instructions for service adjustments and service procedures for each light amplification by stimulated emission of radiation product model, including clear warnings and precautions to exist taken to avoid possible exposure to laser and collateral radiation in excess of the accessible emission limits in tables I, 2-A, Two, III-A, III-B, and Vi of paragraph (d) of this section, and a schedule of maintenance necessary to go along the production in compliance with this department and § 1040.eleven; and in all such service instructions, a list of those controls and procedures that could be utilized past persons other than the manufacturers or the manufacturer'south agents to increase accessible emission levels of radiations and a clear description of the location of displaceable portions of the protective housing that could allow human being admission to light amplification by stimulated emission of radiation or collateral radiation in backlog of the accessible emission limits in tables I, Two-A, 2, III-A, Three-B, and VI of paragraph (d) of this section. The instructions shall include protective procedures for service personnel to avoid exposure to levels of light amplification by stimulated emission of radiation and collateral radiation known to be hazardous for each procedure or sequence of procedures to exist 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 nether § 1010.two, by any person engaged in the business of manufacturing, assembling, or modifying laser products shall exist construed as manufacturing under the act if the modification affects any aspect of the product's operation or intended part(s) for which this department and § 1040.11 have an applicable requirement. The manufacturer who performs such modification shall recertify and reidentify the production in accordance with the provisions of §§ 1010.2. and 1010.3.

¹ Course I levels of laser radiation are non considered to be hazardous.

ⁱⁱ Class IIa levels of laser radiation are non considered to be hazardous if viewed for any period of fourth dimension 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 ane * 10 ^three seconds.

ⁱⁱⁱ Grade Ii levels of laser radiation are considered to be a chronic viewing hazard.

⁴ Form 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 direct with optical instruments.

⁵ Class IIIb levels of laser radiation are considered to exist an acute chance to the peel and eyes from directly radiation.

⁶ Grade Four levels of laser radiations are considered to be an acute risk to the pare and optics from direct and scattered radiation.

(one) The factors 1000 one and chiliad 2 are wavelength-dependent correction factors adamant from table IV.

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

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

[50 FR 33688, Aug. twenty, 1985; 50 FR 42156, Oct. eighteen, 1985; 65 FR 17138, Mar. 31, 2000, every bit amended at 75 FR 20917, April. 22, 2010; 83 FR 13864, April. two, 2018]