(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 X 10-3 steradian with collimating optics of 5 diopters or less. For scanned laser radiation, the direction of the solid angle of acceptance shall change as needed to maximize detectable radiation, with an angular speed of up to 5 radians/second. A 50 millimeter diameter aperture stop with the same collimating optics and acceptance angle stated above shall be used for all other laser products (except that a 7 millimeter diameter aperture stop shall be used in the measurement of scanned laser radiation emitted by laser products manufactured on or before August 20, 1986.

(ii) The irradiance (W cm-2) or radiant exposure (J cm-2 equivalent to the radiant power (W) or radiant energy (J) detectable through a circular aperture stop having a diameter of 7 millimeters and, for irradiance, within a circular solid angle of acceptance of 1 x 10-3 steradian with collimating optics of 5 diopters or less, divided by the area of the aperture stop (cm-2).

(iii) The radiance (W cm-2 sr-1) or integrated radiance (J cm-2 sr-1) equivalent to the radiant power (W) or radiant energy (J) detectable through a circular aperture stop having a diameter of 7 millimeters and within a circular solid angle of acceptance of 1 X 10-5 steradian with collimating optics of 5 diopters or less, divided by that solid angle (sr) and by the area of the aperture stop (cm-2).

(f) Performance requirements-(1) Protective housing. Each laser product shall have a protective housing that prevents human access during operation

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 hous

ing 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 rootmean-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 ПIa, 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 Ila 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."