CSA C22.2 No. 61010-2-040:21

(IEC 61010-2-040:2020, MOD)

National Standard of Canada Norme nationale du Canada

CSA C22.2 No. 61010-2-040:21

Safety requirements for electrical equipment for measurement, control, and laboratory use — Part 2-040: Particular requirements for sterilizers and washer- disinfectors used to treat medical materials

(IEC 61010-2-040:2020, MOD)

CSA C22.2 nº 61010-2-040:21

Exigences de sécurité pour appareils électriques de mesurage, de régulation et de laboratoire — Partie 2-040 : Exigences particulières pour sterilisateurs et laveurs desinfecteurs utilisés pour traiter le matériel médical

(IEC 61010-2-040:2020, MOD)

© IEC 2020. © Canadian Standards Association 2021. All rights reserved. Unauthorized reproduction is strictly prohibited.

© IEC 2020. © Association canadienne de normalisation 2021. Tous droits réservés. Toute reproduction sans autorisation est strictement interdite.

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 C22.2 No. 61010-2-040:21

  March 2021

  
  

  Title: Safety requirements for electrical equipment for measurement, control, and

  laboratory use — Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials

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

• go to www.csagroup.org/store/

• click on Product Updates

The List ID that you will need to register for updates to this publication is 2428773.

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 est disponible en versions française et anglaise.

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 C22.2 No. 61010-2-040:21

Safety requirements for electrical equipment for measurement, control, and laboratory use —

Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials

(IEC 61010-2-040:2020, MOD)

Prepared by

International Electrotechnical Commission

Reviewed by

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

Published in March 2021 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 www.csagroup.org/store/

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

ICS 19.080; 71.040.10

ISBN 978-1-4883-3468-9

© 2021 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 C22.2 No. 61010-2-040:21

Safety requirements for electrical equipment for measurement, control, and laboratory use — Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials

CSA C22.2 No. 61010-2-040:21

Safety requirements for electrical equipment for measurement, control, and laboratory use — Part 2-040: Particular requirements for sterilizers and washer- disinfectors used to treat medical materials

(IEC 61010-2-040:2020, MOD)

CSA Preface

This is the third edition of CSA C22.2 No. 61010-2-040, Safety requirements for electrical equipment for measurement, control, and laboratory use — Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials, which is an adoption, with Canadian deviations, of the identically titled IEC (International Electrotechnical Commission) Standard 61010-2-040 (third edition, 2020-05). It supersedes the previous edition published in 2016 as

CAN/CSA-C22.2 No. 61010-2-040 (adopted IEC 61010-2-040:2015). It is one in a series of Standards issued by CSA Group under Part II of the Canadian Electrical Code.

For brevity, this Standard will be referred to as “CSA C22.2 No. 61010-2-040” throughout.

This Standard is intended to be used in conjunction with CAN/CSA-C22.2 No. 61010-1:12, Safety requirements for electrical equipment for measurement, control, and laboratory use — Part 1: General requirements (adopted IEC 61010-1:2010, with Canadian and US deviations); and Amendment 1:2018 to CAN/CSA-C22.2 No. 61010-1:12 (adopted IEC Amendment 1:2016, with Canadian and US deviations).

This Standard is considered suitable for use for conformity assessment within the stated scope of the Standard.

This Standard was reviewed for Canadian adoption by the CSA Subcommittee on Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use, under the jurisdiction of the CSA Technical Committee on Consumer and Commercial Products and the CSA Strategic Steering Committee on Requirements for Electrical Safety, 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.

March 2021 © 2021 Canadian Standards Association CSA/8

CSA C22.2 No. 61010-2-040:21

Safety requirements for electrical equipment for measurement, control, and laboratory use — Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials

Interpretations: The Strategic Steering Committee on Requirements for Electrical Safety has provided the following direction for the interpretations of standards under its jurisdiction: “The literal text shall be used in judging compliance of products with the safety requirements of this Standard. When the literal text cannot be applied to the product, such as for new materials or construction, and when a relevant CSA committee interpretation has not already been published, CSA Group’s procedures for interpretation shall be followed to determine the intended safety principle.”

© 2021 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. IEC material is reprinted with permission. Where the words “this International Standard” appear in the text, they should be interpreted as “this National Standard of Canada”.

Inquiries regarding this National Standard of Canada should be addressed to CSA Group

178 Rexdale Boulevard, Toronto, Ontario, Canada M9W 1R3 1-800-463-6727 • 416-747-4000

www.csagroup.org

To purchase standards and related publications, visit our Online Store at www.csagroup.org/store/ or call toll-free 1-800-463-6727 or 416-747-4044.

This Standard is subject to review within five years from the date of publication, and suggestions for its improvement will be referred to the appropriate committee. The technical content of IEC and ISO publications is kept under constant review by IEC and ISO. 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.

March 2021 © 2021 Canadian Standards Association CSA/9

– 2 – IEC 61010-2-040:2020 © IEC 2020

CONTENTS

FOREWORD 3

1. Scope and object 5

2. Normative references 6

3. Terms and definitions 6

4. Tests 7

5. Marking and documentation 9

6. Protection against electric shock 14

7. Protection against mechanical HAZARDS and against HAZARDS related to

   mechanical functions 15

8. Resistance to mechanical stresses 19

9. Protection against the spread of fire 19

10. Equipment temperature limits and resistance to heat 20

11. Protection against HAZARDS from fluids and solid foreign objects 21

12. Protection against radiation, including laser sources, and against sonic and

    ultrasonic pressure 24

13. Protection against liberated gases, substances, explosion and implosion 25

14. Components and subassemblies 30

15. Protection by interlocks 32

16. HAZARDS resulting from application 32

17. RISK assessment 32

Annexes 33

Annex G (informative) Leakage and rupture from fluids under pressure 33

Annex L (informative) Index of defined terms 34

Bibliography 35

CSA C22.2 No. 61010-2-040:21

IEC 61010-2-040:2020 © IEC 2020 – 5 –

SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL, AND LABORATORY USE –

Part 2-040: Particular requirements for STERILIZERS and

WASHER-DISINFECTORS used to treat medical materials

1 Scope and object

This clause of Part 1 is applicable except as follows:

1. Equipment included in scope

   
   

   Replacement:

   
   

   Replace the existing text with the following:

   
   

   This part of IEC 61010 specifies safety requirements for electrical equipment intended for sterilization, washing, and disinfection of medical materials in the medical, veterinary, pharmaceutical and laboratory fields, when used under the environmental conditions of 1.4.

   
   

   Examples of such equipment include the following:

   1. STERILIZERS and disinfectors using steam and/or hot water as the sterilant;

   2. STERILIZERS and disinfectors using toxic gas, toxic aerosol or toxic vapour as the sterilant;

   3. STERILIZERS and disinfectors using hot air or hot inert gas as the sterilant; and

   4. WASHER-DISINFECTORS.

   
   

2. Equipment excluded from scope

Addition:

Add the following note to item f):

NOTE IEC 60601-1:2005, 3.63, defines "medical electrical equipment" as follows (notes to entry are omitted):

Electrical equipment, having an applied part or transferring energy to or from the patient or detecting such energy transfer to or from the patient and which is:

1. provided with not more than one connection to a particular supply MAINS; and

   
   

2. intended by its manufacturer to be used:

   
   

   1. in the diagnosis, treatment, or monitoring of a patient; or

      
      

   2. for compensation or alleviation of disease, injury or disability.

Addition:

Add the following new second paragraph after the lettered list:

This document does not apply to the following types of equipment:

aa) equipment for use in hazardous atmospheres (see IEC 60079); however this document does apply to an atmosphere created inside equipment by a flammable sterilizing agent (see 13.2.101 and 13.2.102);

bb) laboratory equipment for the heating of materials for purposes other than sterilization or disinfection (see IEC 61010-2-010);

CSA C22.2 No. 61010-2-040:21