IEC 61010-2-040:2020

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 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.
This third edition cancels and replaces the second edition published in 2015. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition:
- it is established on the basis of the third edition (2010) of IEC 61010‑1 and its Amendment 1 (2016);
- added tolerance for stability of a.c. voltage test equipment to 6.8.3.1;
- the status of a Group Safety Publication has been removed (this does not change the technical requirements in the document).

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

L'IEC 61010-2-040:2020 définit les exigences de sécurité pour les appareils électriques destinés à la stérilisation, au lavage et à la désinfection du matériel médical dans les domaines médicaux, vétérinaires, pharmaceutiques et de laboratoire, lorsqu'ils sont utilisés dans les conditions d'environnement de 1.4. Exemples de ce type d'appareils:
- les stérilisateurs et désinfecteurs utilisant la vapeur et/ou l'eau chaude comme agent stérilisant;
- les stérilisateurs et désinfecteurs utilisant le gaz toxique, l'aérosol toxique, ou la vapeur toxique comme agent stérilisant;
- les stérilisateurs et désinfecteurs utilisant de l'air chaud ou du gaz inerte chaud comme agent stérilisant; et
- les laveurs désinfecteurs.
Cette troisième édition annule et remplace la deuxième édition parue en 2015. Cette édition constitue une révision technique. Cette édition inclut les modifications techniques majeures suivantes par rapport à l'édition précédente:
- elle est établie sur la base de la troisième édition (2010) de l'IEC 61010-1 et son Amendement 1 (2016);
- tolérance ajoutée pour la stabilité des matériels d'essai sous tension alternative spécifiés en 6.8.3.1;
- le statut de publication groupée de sécurité a été supprimé (ce qui ne modifie pas les exigences techniques du document).

General Information

• Status: Published
• Publication Date: 13-May-2020
• ICS: 01 - GENERALITIES. TERMINOLOGY. STANDARDIZATION. DOCUMENTATION
• ICS: 19.080 - Electrical and electronic testing
• ICS: 71.040.10 - Chemical laboratories. Laboratory equipment
• Technical Committee: TC 66 - Safety of measuring, control and laboratory equipment
• Drafting Committee: MT 15 - TC 66/MT 15
• Current Stage: PPUB - Publication issued
• Start Date: 05-Jun-2020
• Completion Date: 14-May-2020

Relations

• Revises: IEC 61010-2-040:2015 - 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
• Effective Date: 05-Sep-2023

Standards Content (Sample)

IEC 61010-2-040 ®
Edition 3.0 2020-05
REDLINE VERSION
INTERNATIONAL
STANDARD
colour
inside
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
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form
or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from
either IEC or IEC's member National Committee in the country of the requester. If you have any questions about IEC
copyright or have an enquiry about obtaining additional rights to this publication, please contact the address below or
your local IEC member National Committee for further information.

IEC Central Office Tel.: [phone]
3, rue de Varembé [e-mail]
CH-1211 Geneva 20 www.iec.ch
Switzerland
About the IEC
The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes
International Standards for all electrical, electronic and related technologies.

About IEC publications
The technical content of IEC publications is kept under constant review by the IEC. Please make sure that you have the
latest edition, a corrigendum or an amendment might have been published.

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variety of criteria (reference number, text, technical containing more than 22 000 terminological entries in English
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and withdrawn publications. Also known as the International Electrotechnical Vocabulary

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IEC 61010-2-040 ®
Edition 3.0 2020-05
REDLINE VERSION
INTERNATIONAL
STANDARD
colour
inside
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
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
ICS 19.080; 71.040.10 ISBN 978-2-8322-8363-9

– 2 – IEC 61010-2-040:2020 RLV © IEC 2020
CONTENTS
FOREWORD . 3
1 Scope and object . 6
2 Normative references . 7
3 Terms and definitions . 7
4 Tests . 9
5 Marking and documentation . 10
6 Protection against electric shock . 15
7 Protection against mechanical HAZARDS and against HAZARDS related to
mechanical functions . 16
8 Mechanical resistance to shock and impact Resistance to mechanical stresses . 21
9 Protection against the spread of fire . 21
10 Equipment temperature limits and resistance to heat . 21
11 Protection against HAZARDS from fluids and solid foreign objects . 22
12 Protection against radiation, including laser sources, and against sonic and
ultrasonic pressure . 25
13 Protection against liberated gases, substances, explosion and implosion . 27
14 Components and subassemblies . 33
15 Protection by interlocks . 34
16 HAZARDS resulting from application . 35
17 RISK assessment . 35
Annexes . 36
Annex G (informative) Leakage and rupture from fluids under pressure . 36
Annex L (informative) Index of defined terms . 37
Bibliography . 38

Table 101 – Lamp or lamp systems considered photobiologically safe .
Table 102 – Lamp or lamp systems considered photobiologically safe under certain
conditions .

INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
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

FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote
international co-operation on all questions concerning standardization in the electrical and electronic fields. To
this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,
Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as "IEC
Publication(s)"). Their preparation is entrusted to technical committees; any IEC National Committee interested
in the subject dealt with may participate in this preparatory work. International, governmental and non-
governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely
with the International Organization for Standardization (ISO) in accordance with conditions determined by
agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
consensus of opinion on the relevant subjects since each technical committee has representation from all
interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
misinterpretation by any end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence
between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
the latter.
5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
services carried out by independent certification bodies.
6) All users should ensure that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
members of its technical committees and IEC National Committees for any personal injury, property damage or
other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
Publications.
8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of
patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
This redline version of the official IEC Standard allows the user to identify the changes
made to the previous edition. A vertical bar appears in the margin wherever a change
has been made. Additions are in green text, deletions are in strikethrough red text.

– 4 – IEC 61010-2-040:2020 RLV © IEC 2020
International Standard IEC 61010-2-040 has been prepared by IEC technical committee 66:
Safety of measuring, control and laboratory equipment.
This third edition cancels and replaces the second edition published in 2015. This edition
constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous
edition:
a) it is established on the basis of the third edition (2010) of IEC 61010‑1 and its
Amendment 1 (2016);
b) added tolerance for stability of a.c. voltage test equipment to 6.8.3.1;
c) the status of a Group Safety Publication has been removed (this does not change the
technical requirements in the document).
The text of this International Standard is based on the following documents:
CDV Report on voting
66/699/CDV 66/716/RVC
Full information on the voting for the approval of this International Standard can be found in
the report on voting indicated in the above table.
This document has been drafted in accordance with the ISO/IEC Directives, Part 2.
The reader's attention is drawn to the fact that Annex G lists all of the "in-some-country"
clauses on differing practices of a less permanent nature relating to the subject of this
standard.
A list of all parts in the IEC 61010 series, published under the general title Safety
requirements for electrical equipment for measurement, control, and laboratory use, can be
found on the IEC website.
This Part 2-040 is to be used in conjunction with IEC 61010-1. It was established on the basis
of the third edition (2010) of IEC 61010-1 and its Amendment 1 (2016), hereinafter referred to
as Part 1.
This Part 2-040 supplements or modifies the corresponding clauses in Part 1 so as to convert
that publication into the IEC standard: Particular requirements for STERILIZERS and WASHER-
DISINFECTORS used to treat medical materials.
Where a particular subclause of Part 1 is not mentioned in this Part 2-040, that subclause
applies as far as is reasonable. Where this Part 2-040 states "addition", "modification",
"replacement", or "deletion", the relevant requirement, test specification or note in Part 1 shall
be adapted accordingly.
In this standard:
1) the following print types are used:
– requirements: in roman type;
– NOTES: in small roman type;
– conformity and tests: in italic type;
– terms used throughout this standard which have been defined in Clause 3: SMALL
ROMAN CAPITALS.
2) subclauses, figures, and tables which are additional to those in Part 1 are numbered
starting from 101; additional annexes are lettered starting from AA and additional list
items are lettered from aa).
The committee has decided that the contents of this document will remain unchanged until the
stability date indicated on the IEC website under "http://webstore.iec.ch" in the data related to
the specific document. At this date, the document will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
IMPORTANT – The 'colour inside' logo on the cover page of this publication indicates
that it contains colours which are considered to be useful for the correct
understanding of its contents. Users should therefore print this document using a
colour printer.
– 6 – IEC 61010-2-040:2020 RLV © IEC 2020
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:
1.1.1 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
...

IEC 61010-2-040 ®
Edition 3.0 2020-05
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
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
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

All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form
or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from
either IEC or IEC's member National Committee in the country of the requester. If you have any questions about IEC
copyright or have an enquiry about obtaining additional rights to this publication, please contact the address below or
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About the IEC
The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes
International Standards for all electrical, electronic and related technologies.

About IEC publications
The technical content of IEC publications is kept under constant review by the IEC. Please make sure that you have the
latest edition, a corrigendum or an amendment might have been published.

IEC publications search - webstore.iec.ch/advsearchform Electropedia - www.electropedia.org
The advanced search enables to find IEC publications by a The world's leading online dictionary on electrotechnology,
variety of criteria (reference number, text, technical containing more than 22 000 terminological entries in English
committee,…). It also gives information on projects, replaced and French, with equivalent terms in 16 additional languages.
and withdrawn publications. Also known as the International Electrotechnical Vocabulary

(IEV) online.
IEC Just Published - webstore.iec.ch/justpublished
Stay up to date on all new IEC publications. Just Published IEC Glossary - std.iec.ch/glossary
details all new publications released. Available online and 67 000 electrotechnical terminology entries in English and
once a month by email. French extracted from the Terms and Definitions clause of
IEC publications issued since 2002. Some entries have been
IEC Customer Service Centre - webstore.iec.ch/csc collected from earlier publications of IEC TC 37, 77, 86 and
If you wish to give us your feedback on this publication or CISPR.

need further assistance, please contact the Customer Service

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IEC 61010-2-040 ®
Edition 3.0 2020-05
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
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
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

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 19.080; 71.040.10 ISBN 978-2-8322-8301-1

– 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

INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
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

FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote
international co-operation on all questions concerning standardization in the electrical and electronic fields. To
this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,
Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as "IEC
Publication(s)"). Their preparation is entrusted to technical committees; any IEC National Committee interested
in the subject dealt with may participate in this preparatory work. International, governmental and non-
governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely
with the International Organization for Standardization (ISO) in accordance with conditions determined by
agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
consensus of opinion on the relevant subjects since each technical committee has representation from all
interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
misinterpretation by any end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence
between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
the latter.
5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
services carried out by independent certification bodies.
6) All users should ensure that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
members of its technical committees and IEC National Committees for any personal injury, property damage or
other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
Publications.
8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of
patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
International Standard IEC 61010-2-040 has been prepared by IEC technical committee 66:
Safety of measuring, control and laboratory equipment.
This third edition cancels and replaces the second edition published in 2015. This edition
constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous
edition:
a) it is established on the basis of the third edition (2010) of IEC 61010‑1 and its
Amendment 1 (2016);
b) added tolerance for stability of a.c. voltage test equipment to 6.8.3.1;

– 4 – IEC 61010-2-040:2020 © IEC 2020
c) the status of a Group Safety Publication has been removed (this does not change the
technical requirements in the document).
The text of this International Standard is based on the following documents:
CDV Report on voting
66/699/CDV 66/716/RVC
Full information on the voting for the approval of this International Standard can be found in
the report on voting indicated in the above table.
This document has been drafted in accordance with the ISO/IEC Directives, Part 2.
The reader's attention is drawn to the fact that Annex G lists all of the "in-some-country"
clauses on differing practices of a less permanent nature relating to the subject of this
standard.
A list of all parts in the IEC 61010 series, published under the general title Safety
requirements for electrical equipment for measurement, control, and laboratory use, can be
found on the IEC website.
This Part 2-040 is to be used in conjunction with IEC 61010-1. It was established on the basis
of the third edition (2010) of IEC 61010-1 and its Amendment 1 (2016), hereinafter referred to
as Part 1.
This Part 2-040 supplements or modifies the corresponding clauses
...