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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 (Adopted IEC 61010-2-040:2020, third edition, 2020-05, with Canadian deviations)
standard by CSA Group, 03/01/2021
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(IEC 61010-2-040:2020, MOD)
National Standard of Canada Norme nationale du Canada
(IEC 61010-2-040:2020, MOD)
(IEC 61010-2-040:2020, MOD)
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CSA C22.2 No. 61010-2-040:21
March 2021
laboratory use — Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials
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National Standard of Canada
CSA C22.2 No. 61010-2-040:21
(IEC 61010-2-040:2020, MOD)
Prepared by
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ICS 19.080; 71.040.10
ISBN 978-1-4883-3468-9
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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
(IEC 61010-2-040:2020, MOD)
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.”
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March 2021 © 2021 Canadian Standards Association CSA/9
– 2 – IEC 61010-2-040:2020 © IEC 2020
CONTENTS
FOREWORD 3
Scope and object 5
Normative references 6
Terms and definitions 6
Tests 7
Marking and documentation 9
Protection against electric shock 14
Protection against mechanical HAZARDS and against HAZARDS related to
mechanical functions 15
Resistance to mechanical stresses 19
Protection against the spread of fire 19
Equipment temperature limits and resistance to heat 20
Protection against HAZARDS from fluids and solid foreign objects 21
Protection against radiation, including laser sources, and against sonic and
ultrasonic pressure 24
Protection against liberated gases, substances, explosion and implosion 25
Components and subassemblies 30
Protection by interlocks 32
HAZARDS resulting from application 32
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:
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:
STERILIZERS and disinfectors using steam and/or hot water as the sterilant;
STERILIZERS and disinfectors using toxic gas, toxic aerosol or toxic vapour as the sterilant;
STERILIZERS and disinfectors using hot air or hot inert gas as the sterilant; and
WASHER-DISINFECTORS.
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:
provided with not more than one connection to a particular supply MAINS; and
intended by its manufacturer to be used:
in the diagnosis, treatment, or monitoring of a patient; or
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