CSA Z386:20

National Standard of Canada

Safe use of lasers in health care

Legal Notice for Standards

Canadian Standards Association (operating as “CSA Group”) develops standards through a consensus standards development process approved by the Standards Council of Canada. This process brings together volunteers representing varied viewpoints and interests to achieve consensus and develop a standard. Although CSA Group administers the process and establishes rules to promote fairness in achieving consensus, it does not independently test, evaluate, or verify the content of standards.

Disclaimer and exclusion of liability

This document is provided without any representations, warranties, or conditions of any kind, express or implied, including, without limitation, implied warranties or conditions concerning this document’s fitness for a particular purpose or use, its merchantability, or its non-infringement of any third party’s intellectual property rights. CSA Group does not warrant the accuracy, completeness, or currency of any of the information published in this document. CSA Group makes no representations or warranties regarding this document’s compliance with any applicable statute, rule, or regulation.

IN NO EVENT SHALL CSA GROUP, ITS VOLUNTEERS, MEMBERS, SUBSIDIARIES, OR AFFILIATED COMPANIES, OR THEIR EMPLOYEES, DIRECTORS, OR OFFICERS, BE LIABLE FOR ANY DIRECT, INDIRECT, OR INCIDENTAL DAMAGES, INJURY, LOSS, COSTS, OR EXPENSES, HOWSOEVER CAUSED, INCLUDING BUT NOT LIMITED TO SPECIAL OR CONSEQUENTIAL DAMAGES, LOST REVENUE, BUSINESS INTERRUPTION, LOST OR DAMAGED DATA, OR ANY OTHER COMMERCIAL OR ECONOMIC LOSS, WHETHER BASED IN CONTRACT, TORT (INCLUDING NEGLIGENCE), OR ANY OTHER THEORY OF LIABILITY, ARISING OUT OF OR RESULTING FROM ACCESS TO OR POSSESSION OR USE OF THIS DOCUMENT, EVEN IF CSA GROUP HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES, INJURY, LOSS, COSTS, OR EXPENSES.

In publishing and making this document available, CSA Group is not undertaking to render professional or other services for or on behalf of any person or entity or to perform any duty owed by any person or entity to another person or entity. The information in this document is directed to those who have the appropriate degree of experience to use and apply its contents, and CSA Group accepts no responsibility whatsoever arising in any way from any and all use of or reliance on the information contained in this document.

CSA Group is a private not-for-profit company that publishes voluntary standards and related documents. CSA Group has no power, nor does it undertake, to enforce compliance with the contents of the standards or other documents it publishes.

Intellectual property rights and ownership

As between CSA Group and the users of this document (whether it be in printed or electronic form), CSA Group is the owner, or the authorized licensee, of all works contained herein that are protected by copyright, all trade-marks (except as otherwise noted to the contrary), and all inventions and trade secrets that may be contained in this document, whether or not such inventions and trade secrets are protected by patents and applications for patents. Without limitation, the unauthorized use, modification, copying, or disclosure of this document may violate laws that protect CSA Group’s and/or others’ intellectual property and may give rise to a right in CSA Group and/or others to seek legal redress for such use, modification, copying, or disclosure. To the extent permitted by licence or by law, CSA Group reserves all intellectual property rights in this document.

Patent rights

Attention is drawn to the possibility that some of the elements of this standard may be the subject of patent rights. CSA Group shall not be held responsible for identifying any or all such patent rights. Users of this standard are expressly advised that determination of the validity of any such patent rights is entirely their own responsibility.

Authorized use of this document

This document is being provided by CSA Group for informational and non-commercial use only. The user of this document is authorized to do only the following:

If this document is in electronic form:

• load this document onto a computer for the sole purpose of reviewing it;

• search and browse this document; and

• print this document if it is in PDF format.

  Limited copies of this document in print or paper form may be distributed only to persons who are authorized by CSA Group to have such copies, and only if this Legal Notice appears on each such copy.

  In addition, users may not and may not permit others to

• alter this document in any way or remove this Legal Notice from the attached standard;

• sell this document without authorization from CSA Group; or

• make an electronic copy of this document.

  If you do not agree with any of the terms and conditions contained in this Legal Notice, you may not load or use this document or make any copies of the contents hereof, and if you do make such copies, you are required to destroy them immediately. Use of this document constitutes your acceptance of the terms and conditions of this Legal Notice.

  
  

  
  

  Standards Update Service

  CSA Z386:20

  July 2020

  
  

  Title: Safe use of lasers in health care

  To register for e-mail notification about any updates to this publication

• go to store.csagroup.org

• click on Product Updates

The List ID that you will need to register for updates to this publication is 2428044.

If you require assistance, please e-mail techsupport@csagroup.org or call 416-747-2233.

Visit CSA Group’s policy on privacy at www.csagroup.org/legal to find out how we protect your personal information.

Canadian Standards Association (operating as “CSA Group”), under whose auspices this National Standard has been produced, was chartered in 1919 and accredited by the Standards Council of Canada to the National Standards system in 1973. It is a not-for- profit, nonstatutory, voluntary membership association engaged in standards development and certification activities.

CSA Group standards reflect a national consensus of producers and users — including manufacturers, consumers, retailers, unions and professional organizations, and governmental agencies. The standards are used widely by industry and commerce and often adopted by municipal, provincial, and federal governments in their regulations, particularly in the fields of health, safety, building and construction, and the environment.

Individuals, companies, and associations across Canada indicate their support for CSA Group’s standards development by

volunteering their time and skills to Committee work and supporting CSA Group’s objectives through sustaining memberships. The more than 7000 committee volunteers and the 2000 sustaining memberships together form CSA Group’s total membership from which its Directors are chosen. Sustaining memberships represent a major source of income for CSA Group’s standards development activities.

CSA Group offers certification and testing services in support of and as an extension to its standards development activities. To ensure the integrity of its certification process, CSA Group regularly and continually audits and inspects products that bear the

CSA Group Mark.

In addition to its head office and laboratory complex in Toronto, CSA Group has regional branch offices in major centres across Canada and inspection and testing agencies in eight countries. Since 1919, CSA Group has developed the necessary expertise to meet its corporate mission: CSA Group is an independent service

organization whose mission is to provide an open and effective forum for activities facilitating the exchange of goods and services through the use of standards, certification and related services to meet national and international needs.

For further information on CSA Group services, write to CSA Group

178 Rexdale Boulevard Toronto, Ontario, M9W 1R3 Canada

A National Standard of Canada is a standard developed by a Standards Council of Canada (SCC) accredited Standards Development Organization, in compliance with requirements and guidance set out by SCC. More information on National Standards of Canada can be found at www.scc.ca.

SCC is a Crown corporation within the portfolio of Innovation, Science and Economic Development (ISED) Canada. With the goal of enhancing Canada's economic competitiveness and social well- being, SCC leads and facilitates the development and use of national and international standards. SCC also coordinates Canadian participation in standards development, and identifies strategies to advance Canadian standardization efforts.

Accreditation services are provided by SCC to various customers, including product certifiers, testing laboratories, and standards development organizations. A list of SCC programs and accredited bodies is publicly available at www.scc.ca.

Standards Council of Canada 600-55 Metcalfe Street Ottawa, Ontario, K1P 6L5 Canada

Cette Norme Nationale du Canada n’est disponible qu’en anglais.

Although the intended primary application of this Standard is stated in its Scope, it is important to note that it remains the responsibility of the users to judge its suitability for their particular purpose.

®A trademark of the Canadian Standards Association, operating as “CSA Group”

National Standard of Canada

CSA Z386:20

Safe use of lasers in health care

®A trademark of the Canadian Standards Association, operating as “CSA Group”

Published in July 2020 by CSA Group

A not-for-profit private sector organization

178 Rexdale Boulevard, Toronto, Ontario, Canada M9W 1R3

To purchase standards and related publications, visit our Online Store at store.csagroup.org

or call toll-free 1-800-463-6727 or 416-747-4044.

ICS 91.040.10; 31.260

ISBN 978-1-4883-2893-0

© 2020 Canadian Standards Association

All rights reserved. No part of this publication may be reproduced in any form whatsoever without the prior permission of the publisher.

CSA Z386:20 Safe use of lasers in health care

Contents

Technical Committee on Perioperative Safety 3 Subcommittee on Laser Safety in Health Care 6 Preface 8

0 Introduction 9

1. General 9

2. Copyright permissions 9

1. Scope 9

   
   

2. Reference publications 10

   
   

3. Definitions 11

   
   

4. Classification of lasers 13

   
   

5. Risk assessment — Hazards, risks, and control measures 14

   1. Risk assessment 14

   2. General requirements for controlling exposure 14

   3. Laser beam-related hazards, risks, and control measures 15

      1. Ocular 15

      2. Skin 17

      3. Fire and explosion 17

      4. Plume and laser-generated air contaminant (LGAC) 19

   4. Non-beam-related hazards, risks, and control measures 20

      1. Infection 20

      2. Gases, dyes, and liquid coolants 21

         
         

6. Responsibilities, education, training, and credentials 21

   1. General 21

   2. Administrative laser personnel 21

      1. Laser safety committee (LSC) 21

      2. Facility administration 22

   3. Laser-specific personnel 23

      1. Laser safety officer (LSO) 23

      2. Laser user (LU) 25

      3. Laser operator 26

   4. Allied health personnel (health care personnel, observers, and trainees) 27

      1. Health care personnel 27

      2. Observers 28

      3. Trainees 28

         
         

7. Administrative controls 29

   1. General 29

   2. Documentation 29

      
      

      July 2020 © 2020 Canadian Standards Association 1

      CSA Z386:20 Safe use of lasers in health care

      
      

   3. Indications for laser system shutdown 30

      
      

8. Other controls 31

   1. NOHA delimitation 31

   2. Laser-controlled area 31

      1. Laser-controlled area procedures 31

      2. Laser-controlled area surfaces 32

      3. Laser storage 32

      4. Laser-controlled area renovations and installations 32

   3. Heating, ventilation, and air conditioning considerations 33

   4. Laser equipment 33

   5. Laser delivery devices 33

   6. Laser instruments 33

   7. Warning signs 33

      
      

9. Patient protection guidance 35

   
   

10. Acquisition, installation, and maintenance of health care lasers 35

    1. Acquisition of health care lasers 35

    2. Acceptance of health care lasers 37

    3. Installation of health care lasers 38

    4. Maintenance of health care lasers 38

Annex A (normative) — Calculation of the NOHA 45

Annex B (informative) — Standard operating procedures (SOPs) 50

Annex C (informative) — Purchase considerations for health care facility equipment 51

Annex D (informative) — Biological effects 53

Annex E (normative) — Education and training of laser personnel 55

July 2020 © 2020 Canadian Standards Association 2

CSA Z386:20 Safe use of lasers in health care

Preface

This is the fifth edition of CSA Z386, Safe use of lasers in health care. It supersedes the previous editions, published in 2014, 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 Safety in Health Care, under the jurisdiction of the Technical Committee on Perioperative Safety and the Strategic Steering Committee on Health and Well-being, and has been formally approved by the Technical Committee.

This Standard has been developed in compliance with Standards Council of Canada requirements for National Standards of Canada. It has been published as a National Standard of Canada by CSA Group. Notes:

1. Use of the singular does not exclude the plural (and vice versa) when the sense allows.

2. Although the intended primary application of this Standard is stated in its Scope, it is important to note that it remains the responsibility of the users of the Standard to judge its suitability for their particular purpose.

3. This Standard was developed by consensus, which is defined by CSA Policy governing standardization — Code of good practice for standardization as “substantial agreement. Consensus implies much more than a simple majority, but not necessarily unanimity”. It is consistent with this definition that a member may be included in the Technical Committee list and yet not be in full agreement with all clauses of this Standard.

4. To submit a request for interpretation of this Standard, please send the following information to

   inquiries@csagroup.org and include “Request for interpretation” in the subject line:

   1. define the problem, making reference to the specific clause, and, where appropriate, include an illustrative sketch;

   2. provide an explanation of circumstances surrounding the actual field condition; and

   3. where possible, phrase the request in such a way that a 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 within five years from the date of publication. Suggestions for its improvement will be referred to the appropriate committee. To submit a proposal for change, please send the following information to inquiries@csagroup.org and include “Proposal for change” in the subject line:

   1. Standard designation (number);

   2. relevant clause, table, and/or figure number;

   3. wording of the proposed change; and

   4. rationale for the change.

July 2020 © 2020 Canadian Standards Association 8

CSA Z386:20 Safe use of lasers in health care

CSA Z386:20

Safe use of lasers in health care

0 Introduction

1. General

   Health care lasers present unique hazards and risks not associated with other types of medical or surgical equipment. This Standard provides laser team members with the engineering, administrative, procedural, and control measures, as well as guidance on the selection and use of PPE, which is necessary for ensuring a safe operating environment and positive patient outcomes.

   
   

2. Copyright permissions

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 and 1b (Figures 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 from the placement and use in the described manner.

1 Scope

1.1

This Standard provides guidance for the safe use of lasers in health care. It applies to all procedures in health care settings where health care lasers are used, including, but not limited to, the following:

1. health care facilities;

2. dental clinics, offices, and facilities;

3. veterinary facilities;

4. laboratories and other research facilities;

5. physician offices;

6. cosmetic and aesthetic treatment facilities;

7. medical teaching facilities;

8. medical professional exhibitions and trade shows; and

9. medical laser servicing organizations.

1.2

This Standard presents the engineering, procedural, personal protective equipment, and administrative controls necessary to ensure the safety of persons at risk in the vicinity of a health care laser, based upon a risk assessment.

Note: A risk assessment is a thorough analysis of the workplace to identify situations, processes, etc. that can cause harm. A risk assessment, performed before policies and procedures are developed, is useful for determining engineering, administrative, and procedural controls and work practices to reduce the risk of laser exposure through

1. identification of hazards;

2. analysis or evaluation of the risks associated with those hazards; and

3. determining appropriate ways to eliminate or control the hazards.

July 2020 © 2020 Canadian Standards Association 9