1、 American National Standard for Safe Use of Lasers in Health Care American National StandardANSI Z136.3 2011 ANSIZ136.3 2011 Revision of ANSI Z136.3-2005 American National Standard for Safe Use of Lasers in Health Care Secretariat Laser Institute of America Approved: December 5, 2011 American Nation
2、al Standards Institute, Inc. American National Standard An American National Standard implies a consensus of those substantially concerned with its scope and provisions. An American National Standard is intended as a guide to aid the manufacturer, the consumer, and the general public. The existence
3、of an American National Standard does not in any respect preclude anyone, whether or not he or she has approved the standard, from manufacturing, marketing, purchasing, or using products, processes or procedures not conforming to the standard. American National Standards are subject to periodic revi
4、ew and users are cautioned to obtain the latest editions. CAUTION NOTICE: This American National Standard may be revised or withdrawn at any time. The procedures of the American National Standards Institute require that action be taken periodically to reaffirm, revise, or withdraw this standard no l
5、ater than five years from the date of publication. Purchasers of American National Standards may receive current information on all standards by calling or writing the American National Standards Institute. Published by Laser Institute of America 13501 Ingenuity Drive, Suite 128 Orlando, FL 32826 IS
6、BN: #978-0-912035-69-7 Copyright 2011 by Laser Institute of America. All rights reserved. No part of this publication may be copied or reproduced in any form, including an electronic retrieval system or be made available on the Internet, a public network, by satellite, or otherwise, without the prio
7、r written permission of the publisher. Printed in the United States of America. i Foreword (This introduction is not a normative part of ANSI Z136.3-2011, American National Standard for Safe Use of Lasers in Health Care.) In 1968, the American National Standards Institute (ANSI) approved the initiat
8、ion of the Safe Use of Lasers Standards Project under the sponsorship of the Telephone Group. Prior to 1985, Z136 standards were developed by ANSI Committee Z136 and submitted for approval and issuance as ANSI Z136 standards. Since 1985, Z136 standards are developed by the ANSI Accredited Standards
9、Committee (ASC) Z136 for Safe Use of Lasers. A copy of the procedures for development of these standards can be obtained from the secretariat, Laser Institute of America, 13501 Ingenuity Drive, Suite 128, Orlando, FL 32826 or viewed at www.z136.org. The present scope of ASC Z136 is to protect agains
10、t hazards associated with the use of lasers and optically radiating diodes. ASC Z136 is responsible for the development and maintenance of this standard. In addition to the consensus body, ASC Z136 is composed of standards subcommittees (SSC) and technical subcommittees (TSC) involved in Z136 standa
11、rds development and an editorial working group (EWG). At the time of this printing, the following standards and technical subcommittees were active: SSC-1 Safe Use of Lasers (parent document) SSC-2 Safe Use of Lasers and LEDs in Telecommunications Applications SSC-3 Safe Use of Lasers in Health Care
12、 SSC-4 Measurements and Instrumentation SSC-5 Safe Use of Lasers in Educational Institutions SSC-6 Safe Use of Lasers Outdoors SSC-7 Eyewear and Protective Barriers SSC-8 Safe Use of Lasers in Research, Development, and Testing SSC-9 Safe Use of Lasers in Manufacturing Environments SSC-10 Safe Use o
13、f Lasers in Entertainment, Displays, and Exhibitions TSC-1 Biological Effects and Medical Surveillance TSC-2 Hazard Evaluation and Classification TSC-4 Control Measures and Training TSC-5 Non-Beam Hazards TSC-7 Analysis and Applications EWG Editorial Working Group ii The six standards currently issu
14、ed are: ANSI Z136.1-2007, American National Standard for Safe Use of Lasers (replaces ANSI Z136.1-2000) ANSI Z136.3-2011, American National Standard for Safe Use of Lasers in Health Care (replaces ANSI Z136.3-2005 American National Standard for Safe Use of Lasers in Health Care Facilities) ANSI Z136
15、.4-2010, American National Standard Recommended Practice for Laser Safety Measurements for Hazard Evaluation (replaces ANSI Z136.4-2005) ANSI Z136.5-2009, American National Standard for Safe Use of Lasers in Educational Institutions (replaces ANSI Z136.5-2000) ANSI Z136.6-2005, American National Sta
16、ndard for Safe Use of Lasers Outdoors (replaces ANSI Z136.6-2000) ANSI Z136.7-2008, American National Standard for Testing and Labeling of Laser Protective Equipment (first edition) This American National Standard is intended to ensure the safe use of lasers in health care, and has been published as
17、 part of the ANSI Z136 series of laser safety standards. The base document of the series is the American National Standard for Safe Use of Lasers, ANSI Z136.1. The procedures and methodologies described in this standard are based on requirements previously established in ANSI Z136.1 and are intended
18、 to give more specific processes for accomplishing laser safety in health care. The purpose of this standard is to provide more specific user processes for accomplishing laser safety protecting anyone who might become exposed during laser use for health care. It provides guidance to personnel who ar
19、e using lasers and institutions where health care lasers are used. It should be recognized that the scope of ANSI Z136.3 includes all circumstances when people may be exposed to a laser when they are being used for health care applications,where laser systems as medical devices are used for diagnosi
20、s of disease, or for preventive, aesthetic, or therapeutic purpose, where bodily structure or function is altered, symptoms are relieved, or any health care application, where a laser is applied by people for health care purposes. This standard includes policies and procedures to ensure laser safety
21、 in any area where a health care laser system, as a medical device, is being used, including hospital facilities, non-hospital facilities, outpatient facilities, individual medical, dental and veterinarian offices, and non-medical locations, such as salons and spas. In general, this standard may be
22、used independently of ANSI Z136.1; however, instances where additional guidance contained in ANSI Z136.1 is required are noted in the text of this document. The body of this iii standard is normative and applies to all health care laser use. The appendices are informative providing examples and disc
23、ipline specific supplementary information. It is expected that this standard will be periodically revised as new information and experience in the use of lasers are gained. Future revisions may have modified content and use of the most current document is highly recommended. While there is considera
24、ble compatibility among existing laser safety standards, some requirements differ among federal, state and international standards and regulations. These differences may have an effect on the particulars of the applicable control measures. Occasionally questions may arise regarding the meaning or in
25、tent of portions of this standard as it relates to specific applications. When the need for an interpretation is brought to the attention of the secretariat, the secretariat will initiate action to prepare an appropriate response. Since ANSI Z136 standards represent a consensus of concerned interest
26、s, it is important to ensure that any interpretation has also received the concurrence of a balance of interests. For this reason, the secretariat is not able to provide an instant response to interpretation requests except in those cases where the matter has previously received formal consideration
27、. Requests for interpretations and suggestions for improvements of the standard are welcome. They should be sent to ASC Z136 Secretariat, Laser Institute of America, 13501 Ingenuity Drive, Suite 128, Orlando, FL 32826. This standard was processed and approved for submittal to ANSI by ASC Z136. Commi
28、ttee approval of the standard does not necessarily imply that all members voted for its approval. Robert Thomas, Committee Chair Sheldon Zimmerman, Committee Vice-Chair Ben Edwards, Committee Secretary iv Notice (This notice is not a normative part of ANSI Z136.3-2011, American National Standard for
29、 Safe Use of Lasers in Health Care.) Z136 standards and recommended practices are developed through a consensus standards development process approved by the American National Standards Institute. The process brings together volunteers representing varied viewpoints and interests to achieve consensu
30、s on laser safety related issues. As secretariat to ASC Z136, the Laser Institute of America (LIA) administers the process and provides financial and clerical support to the committee. The LIA and its directors, officers, employees, members, affiliates, and sponsors, expressly disclaim liability for
31、 any personal injury, property, or other damages of any nature whatsoever, whether special, indirect, consequential, or compensatory, directly or indirectly resulting from the publication, use of, or reliance on this document or these standards. The LIAs service as secretariat does not constitute, a
32、nd LIA does not make any endorsement, warranty, or referral of any particular standards, practices, goods, or services that may be referenced in this document. The LIA also makes no guarantee or warranty as to the accuracy or completeness of any information published herein. The LIA has no power, no
33、r does it undertake to police or enforce compliance with the contents of this document. In issuing and making this document available, the LIA is not undertaking to render professional or other services for or on behalf of any person or entity. Nor is the LIA undertaking to perform any duty owed by
34、any person or entity to someone else. Anyone using this document should rely on his or her own independent judgment or, as appropriate, seek the advice of a competent professional in determining the exercise of reasonable care in any given circumstances. v Participants At the time it approved this s
35、tandard, ASC Z136 had the following members: Organization Represented Name of Representative Altos Photonics, Inc. Lucian Hand American Academy of Dermatology Mark Nestor American College of Obstetricians unique problems related to hospitals and operating rooms (ORs) and non-hospital settings such a
36、s outpatient clinics, mobile laser units, AMERICAN NATIONAL STANDARD Z136.3-2011 2 individual medical, dental and veterinarian offices, and any location where an HCLS is being used such as salons and spas. The control measures of this standard apply to all locations where laser radiation is applied
37、for health care applications. Suggestions for safe use of specific types of HCLSs, as well as their use in various disciplines, specialties and subspecialties are included in the Appendixes. The Federal Laser Product Performance Standard (FLPPS) for laser products, Code of Federal Regulations (CFR)1
38、, requires that the operating manuals for HCLSs contain adequate instructions for assembly, calibration (Class 3 and Class 4 laser products), operation and maintenance, including necessary precautions to avoid possible exposure to hazardous levels of laser and/or collateral radiation (see Appendix G
39、). Users of HCLSs should obtain information from the operators manual or obtain written information from the manufacturer on suitable laser protective eyewear (LPE), the nominal hazard zone (NHZ), calibration procedures, or adequate instructions for safe use. If the manufacturers labeling safety inf
40、ormation does not exist and cannot be obtained from the manufacturer or the distributor of the laser system, the laser safety officer (LSO) shall provide safety instructions, which shall be incorporated into the policies and procedures (P and those in the ultraviolet and far-infrared regions, in whi
41、ch the main hazard is to the cornea and skin (see Appendix A3, and Tables A1, A2 and A3).42) Comply with the control measures (see Section 4.1) recommended for the appropriate laser class. NOTEIn general, Class 4 HCLSs present an eye, skin and fire hazard, and appropriate precautions should be taken
42、. Surgical lasers and laser systems are mostly Class 4, with a few exceptions at the higher levels of Class 3B. 1.2.2 Federal, State and Local Regulations. The Food and Drug Administrations (FDA) Center for Devices and Radiological Health (CDRH) has the responsibility for implementing and enforcing
43、the FLPPS and the sections of the Food, Drug and Cosmetic Act applicable to medical devices. These regulations have an important bearing on the regulatory status of an HCLS (see Appendix G). State and local requirements may also apply. Some states require personnel who use an HCLS to be licensed or
44、to work under the supervision of licensed individuals who use lasers within their scope of practice, license, training and experience. Some states have specific registration, facility licensing, training and educational requirements for laser installations, users and operators. The LSO shall be resp
45、onsible for obtaining and maintaining individual state requirements and licenses. 1.2.3 Non-governmental Controls. Non-governmental organizations such as The Joint Commission (TJC, formerly known as The Joint Commission on Accreditation of Healthcare Organizations, JCAHO), the Association of Periope
46、rative Registered Nurses (AORN), the American Society for Lasers in Medicine and Surgery (ASLMS), the American Veterinary Medical Association (AVMA), and the Academy of Laser Dentistry (ALD), have referenced ANSI Z136.1 and Z136.3 as guidelines.5These non-governmental organizations have recommended
47、practices, guidelines, or position statements associated with their disciplines and laser uses. 4NOTES in this standard are used as explanatory statements, for emphasis or to offer informative suggestions about technical contentNOTES are not normative. 5Reference to ANSI standards that do not includ
48、e the year of publication means the latest revision thereof. AMERICAN NATIONAL STANDARD Z136.3-2011 7 1.3 Laser Safety Officer (LSO). 1.3.1 General. The LSO is the one person in each facility or organization responsible for the laser safety program. This individual has the training and experience to
49、 administer a laser safety program. The LSO is authorized by the HCF administration and is responsible for monitoring and overseeing the control of laser hazards. The LSO shall effect the knowledgeable evaluation and control of laser hazards by utilizing, when necessary, the most appropriate clinical and technical support staff and other resources. Throughout the body of this standard, it shall be understood that wherever duties or responsibilities of the LSO are specified, it will mean that the LSO either performs the stated task or ensures that the task is performed by qualifie
