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18、te ServiceZ386-14March 2014Title: Safe use of lasers in health careTo register for e-mail notification about any updates to this publication go to shop.csa.ca click on CSA Update ServiceThe List ID that you will need to register for updates to this publication is 2422461.If you require assistance, p
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21、3-6727 or 416-747-4044.TMA trade-mar k of the Canadian S tandards Association, operating as “CSA Group”Safe use of lasers in health careZ386-14Z386-14Safe use of lasers in health careMarch 2014 2014 CSA Group 1ContentsTechnical Committee on Perioperative Safety 3Subcommittee on Laser Safety in Healt
22、h Care 5Preface 70 Introduction 81 Scope 82 Reference publications 93 Definitions 104 Classification of lasers 125 Risk assessment Hazards, risks, and control measures 135.1 Risk assessment 135.2 Hazards, risks, and control measures 135.3 Laser beam-related hazards, risks, and control measures 135.3
23、.1 Ocular 135.3.2 Skin 155.3.3 Fire and explosion 165.3.4 Plume and laser generated air contaminant (LGAC) 185.4 Non-beam related hazards, risks, and control measures 185.4.1 Infection 185.4.2 Gases, dyes, and liquid coolants 196 Responsibilities, education, training, and credentials 206.1 General 2
24、06.2 Administrative laser personnel 206.2.1 Laser safety committee (LSC) 206.2.2 Facility administration 216.3 Laser-specific personnel 226.3.1 Laser safety officer (LSO) 226.3.2 Laser user (LU) 236.3.3 Laser operator (LO) 246.4 Allied health personnel (health care personnel, observers, and trainees
25、) 256.4.1 Health care personnel 256.4.2 Observers 266.4.3 Trainees 267 Administrative controls 277.1 General 277.2 Documentation 277.3 Indications for laser system shutdown 28Z386-14Safe use of lasers in health careMarch 2014 2014 CSA Group 28 Other controls 298.1 Nominal ocular hazard area (NOHA) d
26、elimitation 298.2 Laser-controlled area 298.2.1 Laser-controlled area procedures 298.2.2 Laser-controlled area surfaces 308.2.3 Laser storage 308.2.4 Laser-controlled area renovations 308.3 Heating, ventilation, and air conditioning considerations 318.4 Laser equipment 318.5 Laser delivery devices 3
27、28.6 Laser instruments 328.7 Warning signs 329 Patient protection guidance 3410 Acquisition, installation, and maintenance of health care lasers 3410.1 Acquisition of health care lasers 3410.2 Acceptance of health care lasers 3610.3 Installation of health care lasers 3710.4 Maintenance of health car
28、e lasers 37Annex A (informative) Calculation of the nominal ocular hazard area (NOHA) 44Annex B (informative) Standard operating procedures (SOPs) 49Annex C (informative) Purchase considerations for health care facility equipment 50Annex D (informative) Biological effects 52Annex E (normative) Educa
29、tion and training of laser personnel 54Annex F (informative) Laser protective eyewear guidance 56Z386-14Safe use of lasers in health careMarch 2014 2014 CSA Group 3Technical Committee on Perioperative SafetyS. Taylor London, OntarioRepresenting General InterestChairM. Armutlu Jewish General Hospital
30、, Montral, QubecRepresenting User ManagementA. Bialachowski St. Josephs Healthcare Hamilton, Hamilton, OntarioRepresenting User ManagementD.A. Chartrand Montreal Neurological Hospital, Montral, QubecRepresenting Health Care ProfessionalsJ.D. Deslauriers Health Canada, Ottawa, OntarioRepresenting Gov
31、ernment and/or Regulatory AuthorityN. Dolan Drger Medical Canada Inc., Richmond Hill, OntarioAssociateB. Hunt Class 1 Inc., Cambridge, OntarioRepresenting Producer InterestR. Khotar Providence Health Care, Vancouver, British ColumbiaRepresenting User ManagementC. Landers Weeneebayko General Hospital
32、, Moose Factory, OntarioRepresenting General InterestJ.Y. Latreille Clarion Medical Technologies Inc., Montral, QubecAssociateK.L. LeDez Memorial University of Newfoundland, St. Johns, Newfoundland and LabradorRepresenting Health Care ProfessionalsZ386-14Safe use of lasers in health careMarch 2014 2
33、014 CSA Group 4B.W. McLeod Maple Ridge, British ColumbiaRepresenting Health Care ProfessionalsG. Mendes GE Healthcare Technologies, Mississauga, OntarioRepresenting Producer InterestP.I. Mendes 3M Canada, London, OntarioAssociateD.H. Piper MAQUET-DYNAMED Inc., Markham, OntarioRepresenting Producer I
34、nterestM. Sagar WorkSafe BC, Vancouver, British ColumbiaRepresenting Government and/or Regulatory AuthorityR.C. Shantz Parkin Architects Limited, Toronto, OntarioRepresenting General InterestP.J. Smalley Technology Concepts International, Chicago, Illinois, USARepresenting General InterestC. Stark L
35、ondon Health Sciences Centre, London, OntarioAssociateH. Thiemann Medical Device Industry Consultant, Perkasie, Pennsylvania, USARepresenting Producer InterestK.L. Warcimaga Selkirk and District General Hospital, Selkirk, ManitobaRepresenting User ManagementJ. Wilding Drger Medical Canada Inc., Rich
36、mond Hill, OntarioRepresenting Producer InterestC. Cortissoz CSA Group, Mississauga, OntarioProject ManagerZ386-14Safe use of lasers in health careMarch 2014 2014 CSA Group5Subcommittee on Laser Safety in Health CareJ.Y. Latreille Clarion Medical Technologies Inc., Montral, QubecChairP.J. Smalley Te
37、chnology Concepts International, Chicago, Illinois, USAVice-ChairH. Bargman University of Toronto, Toronto, OntarioJ. Chahal JC Biomedical International Ltd., Calgary, AlbertaJ.D. Deslauriers Health Canada, Ottawa, OntarioS. Elbekai University of Alberta Hospital, Edmonton, AlbertaW.J. Ertle Rockwel
38、l Laser Industries, Cincinnati, Ohio, USAL.W. Ineson Instrumed Surgical, Mississauga, OntarioA. Jaber Humber River Regional Hospital, Toronto, OntarioA.M. Majewski University Health Network, Toronto, OntarioD.R. Palmerton Buffalo Filter, Lancaster, New York, USAJ. Paradis Health Canada, Ottawa, Onta
39、rioJ. Rao University of Alberta, Edmonton, AlbertaZ386-14Safe use of lasers in health careMarch 2014 2014 CSA Group 6S. Taylor London, OntarioB. Haydon CSA Group, Mississauga, OntarioProject ManagerZ386-14Safe use of lasers in health careMarch 2014 2014 CSA Group 7PrefaceThis is the fourth edition o
40、f CSA Z386, Safe use of lasers in health care. It supersedes the previous editions, published in 2008 under the title Safe use of lasers in health care facilities and in 2001 and 1992 under the title Laser Safety in Health Care Facilities.This Standard was prepared by the Subcommittee on Laser Safet
41、y in Health Care, under the jurisdiction of the Technical Committee on Perioperative Safety and the Strategic Steering Committee on Health Care Technology b) provide an explanation of circumstances surrounding the actual field condition; andc) where possible, phrase the request in such a way that a
42、specific “yes” or “no” answer will address the issue.Committee interpretations are processed in accordance with the CSA Directives and guidelines governing standardization and are available on the Current Standards Activities page at standardsactivities.csa.ca.5) This Standard is subject to review f
43、ive years from the date of publication, and suggestions for its improvement will be referred to the appropriate committee. To submit a proposal for change, please send the following information to inquiriescsagroup.org and include “Proposal for change” in the subject line:a) Standard designation (nu
44、mber);b) relevant clause, table, and/or figure number;c) wording of the proposed change; andd) rationale for the change.Z386-14Safe use of lasers in health careMarch 2014 2014 CSA Group 8Z386-14Safe use of lasers in health care0 Introduction0.1 In many situations, lasers offer several advantages ove
45、r traditional health care approaches. These include enhanced precision and speed, utilization of improved surgical access via endoscopes, minimal thermal damage and blood loss, and improved healing and reduced pain following surgery. As a consequence, the use of lasers in health care continues to gr
46、ow, with new equipment and procedures constantly evolving.0.2 Although the use of lasers has its benefits, experience with laser systems for health care has shown that there can be health risks for persons operating unfamiliar laser equipment and accessories, and that non- beam hazards such as fire,
47、 toxic fumes, and electrical shock can occur. Positive patient outcomes depend on knowledgeable staff and the safe and effective use of lasers in health care settings.0.3 Clause 4.7.3.2 (Clause 8.7.7 in this Standard) and Clause 4.7.4 (Clause 8.7.8 in this Standard), and Figures 1a, 1b, and 1d (Figu
48、res 2, 3, and 4 in this Standard) are reproduced with permission from ANSI Z136.3-2011, American National Standard for Safe Use of Lasers in Health Care. Copyright 2011, Laser Institute of America, Orlando, Florida. The Laser Institute of America disclaims any responsibility or liability resulting f
49、rom the placement and use in the described manner.1 Scope1.1 This Standard provides guidance for the safe use of lasers in health care. It applies to all procedures in health care settings where health-related lasers are used, including, but not limited to, the following:a) health care facilities;b) dental clinics, offices, and facilities;c) veterinary facilities;d) laboratories and other research facilities;e) physician offices;f) cosmetic and aesthetic treatment facilities;g) medical teaching facilities;h) medical professional exhibi
