| (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. (2) Skin protection. When there is a possibility of exposure to laser radiation that exceeds the MPE limits for skin as specified in ANSI Z136.1-2000 Safe Use of Lasers, the registrant shall require the appropriate use of protective gloves, clothing, or shields. (u) NHZ. Where applicable, in the presence of unenclosed Class 3b and Class 4 laser beam paths, an NHZ shall be established. If the beam of an unenclosed Class 3b and Class 4 laser is contained within a region by adequate control measures to protect personnel from exposure to levels of radiation above the appropriate MPE, as delineated in ANSI Z136.1-2000, Safe Use of Lasers, that region may be considered to be the NHZ. The NHZ may be determined by information supplied by the laser manufacturer, by measurement, or by using the appropriate laser range equation or other equivalent assessment. (v) Caution signs, labels, and posting for lasers and IPL devices. (1) General requirements. Except as otherwise authorized by the agency, signs, symbols, and labels prescribed by this section shall use the design and colors specified in subsection (dd) of this section. (2) Posting. The laser controlled area shall be conspicuously posted with a sign or signs as specified in paragraph (3) of this subsection and subsection (dd) of this section. (3) Labeling lasers and posting laser facilities. All signs and labels associated with Class 2, 3a, 3b, and 4 lasers shall contain the following wording. (A) The signal word "CAUTION" shall be used with all signs and labels associated with all Class 2 lasers and all Class 3a lasers that do not exceed the appropriate MPE, as designated in ANSI Z136.1-2000, Safe Use of Lasers. This signal word is used in accordance with the sign in subsection (dd)(1) of this section. (B) The signal word "DANGER" shall be used with all Class 3a lasers that exceed the appropriate MPE, as designated in ANSI Z136.1-2000, Safe Use of Lasers, and all Class 3b and 4 lasers. This signal word is used in accordance with the sign in subsection (dd)(2) of this section. (C) Position 1 in the signs in subsection (dd)(1) and (dd)(2) of this section shall contain the following information, as applicable: (i) for all Class 2 lasers, the words "LASER RADIATION - DO NOT STARE INTO BEAM"; (ii) for Class 3a lasers that do not exceed the appropriate MPE, as designated in ANSI Z136.1-2000, Safe Use of Lasers, the words "LASER RADIATION - DO NOT STARE INTO BEAM OR VIEW DIRECTLY WITH OPTICAL INSTRUMENTS"; (iii) for all other Class 3a lasers, the words "LASER RADIATION - AVOID DIRECT EYE EXPOSURE"; (iv) for all Class 3b lasers, the words "LASER RADIATION - AVOID DIRECT EYE EXPOSURE"; or (v) for Class 4 lasers, the words "LASER RADIATION - AVOID EYE or SKIN EXPOSURE to DIRECT or SCATTERED RADIATION". (D) Positions 2 and 3 in the signs in subsections (dd)(1) and (2) of this section shall contain the following information, as applicable. (i) Position 2 shall contain the type of laser or the emitted wavelength, pulse duration (if appropriate), or maximum output. (ii) Position 3 shall contain the class of laser. (E) Lasers, except lasers used in the practice of medicine, shall have a label(s) in close proximity to each aperture through which is emitted accessible laser or collateral radiation in excess of the limits specified in ANSI Z136.1-2000, Safe Use of Lasers and the collateral limits listed in Title 21, CFR, §1040.10, with 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. (iii) "AVOID EXPOSURE - Hazardous x-rays are emitted from this aperture," if the radiation emitted through such aperture is collateral x-ray radiation. (F) Each noninterlocked or defeatably interlocked portion of the protective housing or enclosure that is designed to be displaced or removed during normal operation or servicing, and that would permit human access to laser or collateral radiation, shall have labels as follows: (i) for Class 3b accessible laser radiation the wording, "DANGER - LASER RADIATION WHEN OPEN. AVOID DIRECT EXPOSURE TO BEAM"; (ii) for Class 4 accessible laser radiation the wording, "DANGER - LASER RADIATION WHEN OPEN. AVOID EYE OR SKIN EXPOSURE TO DIRECT OR SCATTERED RADIATION"; or (iii) for collateral radiation in excess of the emission limits as described in Title 21, CFR, §1040.10, "CAUTION - HAZARDOUS ELECTROMAGNETIC RADIATION WHEN OPEN" and "CAUTION - HAZARDOUS X-RAY RADIATION" as applicable. (G) For protective housing or enclosures that provide a defeatable interlock, the words "and interlock defeated" shall be included in the labels specified in subparagraph (F)(i) and (ii) of this paragraph. (H) Other required information. Cont'd... |
