| (II) laser radiation in excess of the accessible emission limits of Class 2 to be emitted directly through the opening created by removal or displacement of that portion of the protective housing. (C) Viewing optics and windows. (i) All viewing ports, viewing optics, or display screens included as an integral part of an enclosed laser or laser product shall incorporate suitable means, (such as interlocks, filters, or attenuators, to maintain the laser radiation at the viewing position at or below the applicable MPE as delineated in ANSI Z136.1-2000, Safe Use of Lasers and the collateral limits listed in Title 21, CFR, §1040.10, under any conditions of operation of the laser. (ii) All collecting optics, such as lenses, telescopes, microscopes, endoscopes, etc., intended for viewing use with a laser shall incorporate suitable means, such as interlocks, filters, or attenuators, to maintain the laser radiation transmitted through the collecting optics to levels at or below the appropriate MPE, as delineated in ANSI Z136.1-2000, Safe Use of Lasers. Normal or prescription eyewear is not considered collecting optics. (D) Warning systems. Each Class 3b or 4 laser or laser product shall provide visual or audible indication during the emission of accessible laser radiation. In the case of Class 3b lasers, except those that allow access only to less than 5 milliwatt (mW) peak visible laser radiation, and Class 4 lasers, this indication shall be sufficient prior to emission of such radiation to allow appropriate action to avoid exposure. Any visual indicator shall be clearly visible through protective eyewear designed specifically for the wavelength(s) of the emitted laser radiation. If the laser and laser energy source are housed separately and can be operated at a separation distance of greater than two meters, both laser and laser energy source shall incorporate visual or audible indicators. The visual indicators shall be positioned so that viewing does not require human access to laser radiation in excess of the MPE, as delineated in ANSI Z136.1-2000, Safe Use of Lasers. (E) Controlled area. With a Class 3b laser, except those that allow access only to less than 5 mW visible peak power, or Class 4 laser, a controlled area shall be established when exposure to the laser radiation in excess of the MPE, as delineated in ANSI Z136.1-2000, Safe Use of Lasers or the collateral limits listed in Title 21, CFR, §1040.10 is possible. The controlled area shall meet the following requirements, as applicable. (i) The area shall be posted as required by subsection (v) of this section. (ii) Access to the controlled area shall be restricted. (iii) For Class 4 indoor controlled areas, latches, interlocks, or other appropriate means shall be used to prevent unauthorized entry into controlled areas. (I) Such measures shall be designed to allow rapid egress by the laser personnel at all times and admittance to the controlled area in an emergency condition. For such emergency conditions, a control-disconnect switch or equivalent device (panic button) shall be available for deactivating the laser. (II) Where safety latches or interlocks are not feasible or are inappropriate, for example during medical procedures, such as surgery, the following shall apply. (-a-) All authorized personnel shall be trained in laser safety and appropriate personal protective equipment shall be provided upon entry. (-b-) A door, blocking barrier, screen, or curtains shall be used to block, screen, or attenuate the laser radiation at the entryway. The level at the exterior of these devices shall not exceed the applicable MPE, as delineated in ANSI Z136.1-2000, Safe Use of Lasers, nor shall personnel experience any exposure above the MPE immediately upon entry. (-c-) At the entryway there shall be a visible or audible signal indicating that the laser is energized and operating at Class 4 levels. A lighted laser warning sign, flashing light (visible through laser protective eyewear), and other appropriate signage are some of the methods to accomplish this requirement. Alternatively, an entryway warning light assembly may be interfaced to the laser in such a manner that one light will indicate when the laser is not operational (high voltage off) and by an additional light when the laser is powered up (high voltage applied, but no laser emission) and by an additional (flashing optional) light that activates when the laser is operating. (iv) For Class 4 indoor controlled areas, during tests requiring continuous operation, the individual in charge of the controlled area shall be permitted to momentarily override the safety interlocks to allow access to other authorized personnel if it is clearly evident that there is no optical radiation hazard at the point of entry, and if the necessary protective devices are being worn by the entering personnel. (v) For Class 4 indoor controlled areas, optical paths (for example, windows) from an indoor facility shall be controlled in such a manner as to reduce the transmitted values of the laser radiation to levels at or below the appropriate ocular MPE, as delineated in ANSI Z136.1-2000, Safe Use of Lasers and the collateral limits listed in Title 21, CFR, §1040.10. When the laser beam must exit the indoor controlled area (as in the case of exterior atmospheric beam paths), the operator shall be responsible for ensuring that air traffic is protected from any laser projecting into navigable air space (contact Federal Aviation Administration (FAA) or other appropriate agencies, as necessary) or controlled ground space when the beam irradiance or radiant exposure is above the appropriate MPE, as delineated in ANSI Z136.1-2000, Safe Use of Lasers. (vi) When the removal of panels or protective covers and/or overriding of interlocks becomes necessary, such as for servicing, testing, or maintenance, and accessible laser radiation exceeds the MPE, as delineated in ANSI Z136.1-2000, Safe Use of Lasers and the collateral limits listed in Title 21, CFR, §1040.10, a temporary controlled area shall be established and posted. (4) Key control. Each Class 3b or 4 laser and IPL device shall incorporate a key-actuated or computer-actuated master control. The key shall be removable and the Class 3b or 4 laser or IPL device shall not be operable when the key is removed. When not being prepared for operation or is unattended, the key will be removed from the device and stored in a location away from the machine. (s) Additional requirements for special lasers and applications. (1) Infrared laser. The beam from a laser shall be terminated in fire-resistant material where necessary. Inspection intervals of absorbent material and actions to be taken in the event or evidence of degradation shall be specified in the operating and safety procedures. (2) Laser optical fiber transmission system. (A) Laser transmission systems that employ optical cables shall be considered enclosed systems with the optical cable forming part of the protective housing. (B) Disconnection of a connector resulting in access to radiation in excess of the applicable MPE limits, as delineated in ANSI Z136.1-2000, Safe Use of Lasers and the collateral limits listed in Title 21, CFR, §1040.10, shall take place in a controlled area. Except for medical lasers whose manufacture has been approved by the FDA, the use of a tool shall be required for the disconnection of a connector for service and maintenance purposes when the connector is not within a secured enclosure. All connectors shall bear the appropriate label or tag specified in subsection (v)(3) of this section. (t) Additional requirements for safe operation. (1) Eye protection. Protective eyewear shall be worn by all individuals with access to Class 3b and/or Class 4 levels of laser radiation. Protective eyewear devices shall meet the following requirements: (A) provide a comfortable and appropriate fit all around the area of the eye; (B) be in proper condition to ensure the optical filter(s) and holder provide the required optical density or greater at the desired wavelengths, and retain all protective properties during its use; (C) be suitable for the specific wavelength of the laser and be of optical density adequate for the energy involved; (D) have the optical density or densities and associated wavelength(s) permanently labeled on the filters or eyewear; and (E) be examined, at intervals not to exceed 12 months, to ensure the reliability of the protective filters and integrity of the protective filter frames. Unreliable eyewear shall be discarded. Documentation of the examination shall be made and maintained in accordance with subsection (ee) of this section for inspection by the agency. Cont'd... |
