![]() | ![]() |
Date Rev: 11/2003
Table of Contents
1. Laser Safety Program Elements
1.1 Abbreviations Used2.
Laser Classification 2.1 Class 13.
Laser Acquisition, Transfer, and Disposal4.
Laser Hazard Control Measures 4.1 Controls for Class 1, 2, and 3a Lasers5.
Laser Safety Training 5.1 Initial Laser Safety Training6.
Laser Related Non-Beam Hazards & Control Measures 6.1 Electrical Hazards7.
Medical Surveillance8.
Laser Accidents 8.1 Immediate Response and General Procedures9.
Standard Operating Procedure (SOP)10.
Resources 10.1 Glossary11.
References1. Laser Safety Program Elements
1.1 Abbreviations Used
ANSI Z136.1 – American National Standards Institute Z136.1-2000 (or latest version thereof) Standard for the Safe Use of Lasers1.2 Purpose
The Duke University laser safety policy is based on the recommendations of ANSI Z136.1, any other pertinent standards, and the applicable federal and state regulations. The laser safety program's primary objective is to ensure that no laser radiation in excess of the MPE reaches the human eye or skin. This program is also intended to ensure adequate protection against laser- related non-beam hazards.
1.3 Responsibilities
1.3.1 Laser Safety Committees responsibilities:
1.3.2 Laser Safety Manager responsibilities:
1.3.3 Principal Laser User responsibilities:
1.3.4 Laser Operator responsibilities:
2. Laser Classification
All lasers and laser systems in the U.S. are categorized into one of several hazard classes. Corresponding labels affixed to the laser or laser system positively identify the class. These laser classifications are detailed in ANSI Z136.1, ANSI Z136.3, and the Federal Laser Products Performance Standard, 21 CFR 1040.10 and 1040.11. The manufacturer provides the classification for most lasers. For custom-built and modified lasers, the LSM can assist with classification.
2.1 Class 1
2.2 Class 2
2.3 Class 3a
2.4 Class 3b
2.5 Class 4
2.6 Embedded Lasers
Lasers are often embedded in laser products or systems with a lower hazard class. When the laser system is used as intended, the controls for the system's class apply. When the system is opened (e.g. for service or alignment) and the embedded laser beam is accessible, a temporary control area must be established. The controls for the temporary control area must be based on the classification of the embedded laser. The user and LSM must determine adequate controls. Confirmation of a system classification is the responsibility of the LSM, and therefore necessitates registering the system. An abbreviated SOP may be required, as in the case of such commercially available enclosed laser systems as a laser scanning confocal microscope.
3. Laser Acquisition, Transfer, and Disposal
Notify the LSM of any decision to purchase, fabricate, or otherwise acquire a Class 3b or Class 4 laser. The LSM will review with the user the hazards of the proposed operation and make recommendations regarding the specific safety requirements that pertain to the proposed use, including requirements for SOPs, laser control areas, training, and personnel protective equipment. Also notify the LSM of any class 3b or 4 laser or laser system relocated, transferred to another PLU or institution, or sent offsite as surplus equipment.
4. Laser Hazard Control Measures
4.1 Controls for Class 1, 2, and 3a Lasers
Class 1, 2, and 3a laser beams may not be intentionally directed at a law enforcement officer or the head or face of another person, except for: - law enforcement purposes by police, or - medical use by authorized medical personnel.
Class 3a laser beams must not be viewed with collecting optics (e.g. microscopes) unless the optical system is specifically designed and constructed to prevent eye exposure exceeding the applicable MPE.
Otherwise, no other specific laser safety requirements apply to Class 1, 2, and 3a lasers.
4.2 Controls for Class 3b and Class 4 Lasers
Class 3b and Class 4 lasers may be operated only in designated laser control areas, including operative suites, patient treatment rooms and patient examination rooms, or in other laser control areas approved by the LSM. The purpose of laser control areas is to confine laser hazards to well-defined spaces that are under the control of the laser user, thereby preventing injury to those visiting and working near the control area. All personnel authorized to enter a Class 3b or Class 4 laser controlled area shall be appropriately trained, and must follow all applicable administrative and operational controls.
4.2.1 Posting
The area must be posted with appropriate warning signs that indicate the nature of the hazard. The wording on the signs will be specified by the LSM and conform to the ANSI Z136.1 guidelines. Such signs shall be posted at all entrances to the laser control area during the time a procedure utilizing the active beam is in progress, and shall be removed when the procedure is completed.
4.2.2 Authorization
Only personnel who have been authorized by the PLU may operate the laser. Personnel may be authorized upon completing the applicable OESO laser safety training. The PLU may stipulate additional authorization requirements. For Non-Clinical Applications, Class 3b and 4 lasers may only be operated upon the LSM’s approval of the responsible PLU’s applicable Non-Clinical Laser Laboratory Authorization.
4.2.3 Beam Stop
All laser beams, other than those applied to tissue for surgical or therapeutic purposes, must be terminated at the end of their useful paths by a material that is non-reflective and (for class 4 lasers) fire resistant.
4.2.4 Eye Protection
Lasers should be mounted so that the beam path is not at eye level for standing or seated personnel. Laser protective eyewear of adequate optical density and threshold limit for the beams under manipulation must be provided and worn at any point where laser exposure could exceed the MPE. Procedures and practices must ensure that optical systems and power levels are not adjusted upstream during critical open beam operations, such as beam alignment. In clinical use, patients must also be provided with eye protection. If the patient is conscious or under conscious sedation, appropriate protective eyewear is to be used. If the patient is under general anesthesia, the eyes are to be protected with wet gauze pads or similar non-flammable material. The need for laser eye protection must be balanced by the need for adequate visible light transmission. It is the responsibility of the PLU to obtain appropriate laser protective eyewear. For assistance in selecting laser eye protection, contact the LSM. The LSM can assist the user in determining the proper parameters of such eyewear, and can provide contact numbers for vendors. Laser eye protection should be inspected periodically to ensure that it is in good condition.
4.2.5 Light Containment
Laser light levels in excess of the MPE must not pass the boundaries of the control area. All windows, doorways, open portals, and other openings through which light might escape from a laser control area must be covered or shielded in such a manner as to preclude the transmission of laser light. Special rules apply for outdoor use and laser control areas that do not provide complete containment. Contact the LSM for details. Where feasible, the laser user is required to keep all laser beams within the operating field, on the optical table or within the experimental envelope at all times. To maintain this control it is essential to be aware of all beams, including stray beams and/or reflections, and to terminate them with beam stops at the end of their useful paths. When a beam traverses to other tables or across aisles, the beam must be enclosed or the access to the aisle must be blocked to prevent personnel from exposure to the beam.
4.3 Additional Controls for Class 4 Lasers
Only appropriately trained personnel may enter a Class 4 laser controlled area during the time a procedure utilizing the active beam is in progress. All personnel within the control area must be provided with appropriate protective equipment and are required to follow all applicable administrative controls. Class 4 laser control areas must meet all of the requirements that apply to Class 3b control areas and also the following requirements:
4.3.1 Rapid Egress and Emergency Access
There must be provisions for rapid egress from a laser control area under all normal and emergency conditions. Any control area interlock system must not interfere with emergency egress. In addition, access control measures must not interfere with the ability of emergency response personnel (fire, paramedical, police) to enter the laser control area in the event operating personnel become injured or incapacitated.
4.3.2 Laser Activation Warning Systems and Entry Controls
Procedural area or entryway controls must be in place to prevent inadvertent entry into a laser control area, or inadvertent exposure to the active laser beam. These measures should include: (a) a visible sign or audible warning sign or signal must be at the entrance to the control area to indicate when the laser is energized and operating; (b) provision of personnel with proper training and laser protective eyewear; and (c) doors or blocking curtains/barriers that attenuate the laser beam to below the MPE at the entranceway. The results of a formal hazard evaluation by the LSM may require more rigorous entryway controls to be put into place, depending upon the level of the hazard. These may include door interlocks or other entryway safety controls.
Locking entryway doors as a means of access control is not acceptable, because it is contrary to the principle of permitting rapid egress or emergency access (see 2.2.1 above).
4.3.3 Key Switches
For those laser systems equipped with a key switch to prevent unauthorized use, the key must not be left in the switch when the laser system is unattended.
4.4 Temporary Laser Control Areas
Temporary laser control areas can be created for the servicing and alignment of embedded lasers, enclosed lasers, and in special cases where permanent laser control areas cannot be provided. They are subject to the normal SOP approval process.
4.5 Special Requirements for Invisible Laser Beams
Since IR and UV laser beams are not within the boundaries of normal human vision, they possess a higher hazard potential than visible light lasers. Because of the invisible nature of the optical radiation, the use of laser eyewear that will protect against worst-case exposures is required at all times.
4.5.1 Infrared Lasers
Infrared laser beams (> 700 nm), other than those applied to tissue for surgical or therapeutic purposes, must be terminated by a highly absorbent, non-specular backstop. Note that many surfaces that appear dull are excellent IR reflectors and would not be suitable for this purpose. Class 4 IR laser beam terminators must be made of a fire-retardant material, or of a material which has been treated to be fire-retardant.
4.5.2 Ultraviolet Lasers
UV radiation causes photochemical reaction in the eyes and the skin, as well as in materials that are found in laboratories. The latter may cause hazardous by-products such as ozone and skin- sensitizing agents. The direct beam and scattered radiation should be shielded to the practical maximum extent to avoid such problems. The use of long-sleeved coats, gloves, and face protectors is recommended. Some medications, including tetracycline, doxycycline, tricyclic antidepressants, and methotrexate, can increase a person's risk to UV radiation. Contact the LSM for more information about this subject.
4.6 Substitution of Alternate Control Measures
Upon documented review by the LSM, the engineering control measures recommended by ANSI Z136.1 for Class 3b and Class 4 lasers or laser systems may be replaced by administrative or other alternate engineering controls that provide equivalent protection. Approvals of these controls are subject to the same review procedure as described in this chapter.
5. Laser Safety Training
5.1 Initial Training
All employees who use Class 3b or Class 4 lasers must complete the appropriate OESO Laser Safety course. Non-Medical laser users must complete the "Laser Safety – Non Clinical Use" course. Healthcare laser users and those nursing and ancillary personnel working in operative or treatment areas during healthcare laser use must complete the appropriate application-specific laser safety course. All of these laser safety courses are available on-line on the OESO Web site or, upon request, by classroom instruction through the LSM.
5.2 Visitors
Guests of DU/DUMC requesting to use or observe Class 3b or Class 4 lasers must contact the LSM regarding the training requirement for non-Duke personnel. New employees and guests may use lasers under the direct supervision of a PLU until completing the training requirement.
5.3 Laser-specific Training
Laser users are also responsible for knowing the safety requirements that apply to their specific laser or laser system and for knowing the contents of the applicable SOP.
5.4 Update Training
Laser users must periodically retake the applicable OESO laser safety course.
6. Laser Related Non-Beam Hazards & Control Measures
While beam hazards are the most prominent laser hazards, other hazards pose equal or possibly greater risk of injury or death. These hazards must be reviewed by the LSM and addressed by the PLU in the SOP for the laser operation where applicable.
6.1 Electrical Hazards
Some lasers use high-voltage power supplies, large capacitors, or capacitor banks that present a lethal shock hazard. Additional hazards of electrical equipment include resistive heating and ignition source. Electrical safety controls include:
6.2 Laser Dyes
Dyes used as the optically active medium in some laser are often toxic and/or carcinogenic chemicals dissolved in flammable solvents. This creates the potential for personnel exposures above permissible limits, fires, and chemical spills. For each dye used, the PLU must have the MSDS available for staff review and in general ensure compliance with applicable Duke policies governing hazardous chemical use and disposal (see the DU Laboratory Safety Manual).
6.3 Compressed Gases and Cryogenics
Hazardous gases may be used in laser applications; i.e. excimer lasers (fluorine, hydrogen chloride). Cryogenic fluids are used in cooling systems of some lasers. The SOP should contain references for the safe handling of compressed gases. See the applicable section of the Duke Laboratory Safety Manual for further guidance.
6.4 Laser Generated Air Contaminants
Air contaminants may be generated when Class 3b and Class 4 laser beams interact with matter. When target irradiance reaches a threshold of about 107 W/cm2, target materials including plastics, composites, metals, and tissues may liberate toxic and noxious airborne contaminants. Generally, the PLU must ensure that any laser operation that creates visible smoke or plume has adequate local exhaust ventilation in place and included in the SOP; respiratory protection is not an acceptable alternative to local exhaust ventilation. If, in addition to local exhaust ventilation, respiratory protection is required or worn voluntarily, consult the Duke Respiratory Protection Policy in the Duke University Safety Manual.
6.5 Plasma Radiation
Interactions between very high power (~1012 W/cm2) laser beams and target materials may produce a plasma, which in turn generates "blue light" and UV emissions that pose an eye and skin hazard. Similarly, targets heated to very high temperatures (e.g. in laser welding and cutting) emit an intense light. The PLU must ensure adequate control measures are in place and addressed in the SOP for such operations.
6.6 UV and Visible Radiation
Laser discharge tubes and pump lamps may generate sufficient UV and visible radiation to pose an eye and skin hazard. To address this issue, maintain the integrity of the laser housing and avoid operating any laser with the housing removed.
6.7 Explosion Hazards
High-pressure arc lamps, filament lamps, and capacitors may explode if they fail during operation. Keep these components enclosed in the laser housing, which will withstand the maximum explosive forces that may be produced. Laser targets and some optical components also may shatter if heat cannot be dissipated quickly enough. Ensure adequate mechanical shielding when exposing brittle materials to high intensity lasers.
6.8 Ionizing Radiation (X-rays)
X-rays could be produced from two main sources: high voltage vacuum tubes of laser power supplies such as rectifiers and thyratrons and electric discharge lasers. Any power supplies that require more than 15 kilovolts may produce enough x-rays to be a health concern. Consult Radiation Safety for review and control of such hazards.
7. Medical Surveillance
Personnel working with Class 3b and/or Class 4 lasers or laser systems are not required to obtain either a pre- or post-employment medical examination specific to laser use. Following any suspected laser injury, employees must report to a supervisor and the Employee Occupational Health & Wellness if they believe that they have been injured.
8. Laser Accidents
8.1 Immediate Response and General Procedures
8.1.1 General Laser Accident Reporting
Laser users must report all laser accidents on site, no matter how minimal, to the PLU responsible for the laser system involved. The PLU must report any accidents causing injury or property damage to the LSM. If immediate assistance from the LSM is required, dial 911 (on DU & DUMC sites), indicate to the Duke Police that a laser accident has occurred, and direct them to notify the Radiation Safety On Call contact person, who will contact the LSM to respond to the situation.
8.1.2. Known or Suspected Laser Overexposure
If a known or suspected overexposure to laser radiation occurs within DU or DUMC:
8.2 Laser Accidents in Duke University Hospital
In addition to the general procedures outlined in Section 8.1, the following actions will also be undertaken if a laser accident occurs in Duke University Hospital.
8.2.1 Occurrence Reporting
8.2.2 Follow-up Procedures by the Laser Safety Manager
The following guidelines describe the initial procedure to be followed by the LSM in the event of a laser accident or incident: If indicated, the LSM will respond on-site to the department reporting the incident. The LSM will document the following information for future review:
The LSM will contact the caller's supervisor to ensure that he/she is informed, and to remind him/her to report incidents to Risk Management via report or telephone (if indicated). If the accident occurred in Duke Hospital, the LSM will contact Clinical Engineering and instruct them to sequester equipment involved in the incident.
The LSM will notify Risk Management and provide them with complete documentation (if indicated). Risk Management will provide further guidance to the LSM if any is necessary.
After the LSM has verified that the exposed individual(s) have received the appropriate medical care, and that the appropriate administrative personnel have been notified of the incident, the LSM will continue to investigate the circumstances of the accident by obtaining the following information:
Following the initial reporting of the alleged or suspected overexposure, the LSM will coordinate with appropriate organizations to prepare a detailed report of the incident. This report shall consist of a summary of the estimated exposure, timetable of medical evaluations, recommendations to prevent recurrence of the incident, and discussion of further medical follow- up recommendations.
When requested by Risk Management/Counsel's Office, the LSM shall provide consulting services on laser incident investigations. When investigation services are requested the investigating individual shall adhere to the following procedures:
9. Standard Operating Procedure (SOP)
An approved written SOP must be provided by the PLU for all Class 3b and Class 4 laser systems. This SOP should cover laser operations (i.e. description of activities, hazard identification and mitigation, routine alignment procedures, schematics of laser set-up) and other relevant hazards in the laser environment. A general laser SOP template is available via the Duke Laser Safety web site. The use of the template is highly recommended. The template provides a guide for the laser user in identifying the characteristics of the laser operation and collateral hazards, and in formulating set-up and alignment procedures. Clinical and research laser users can also use an interactive "application-specific" on-line template on the OESO Web site. Contact the LSM for assistance in developing control measures and completing the SOP.
In the case of enclosed systems (e.g. laser scanning confocal microscopy) an abbreviated SOP can be applied after an experimental review by the LSM, who will then determine the SOP sections required. This abbreviated SOP follows the standard SOP approval process.
All SOPs need to be reviewed annually by personnel working with lasers to ensure the accuracy of the procedure(s). If no new hazards have been added to the system, the users can perform the review without notifying the LSM. If new hazards (use of a sub-nanosecond laser system, for example) have been added to the experiment, a review by the LSM is necessary to assure all applicable safeguards have been satisfied.
A specified time period, agreed upon by both the PLU and the LSM, will be established between the setting up of the laser equipment and the submittal of the SOP draft document. With the assistance of the user the LSM will develop a set of documented conditions for the laser user to operate the laser during the interim. These conditions will be posted in the laser environment and sent to the appropriate departmental safety coordinator.
10. Additional Resources
10.1 Glossary
10.2 Standard Operating Procedure (SOP) Template
11. References
(1) American National Standards Institute (ANSI) Z136.1-2000, American National Standard for the Safe Use of Lasers (or later revision)