SIST EN IEC 61010-2-040:2022
(Main)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)
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)
IEC 61010-2-040:2020 is available as IEC 61010-2-040:2020 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.
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).
Sicherheitsbestimmungen für elektrische Mess-, Steuer-, Regel- und Laborgeräte - Teil 2-040: Besondere Anforderungen an Sterilisatoren und Reinigungs-Desinfektionsgeräte für die Behandlung medizinischen Materials (IEC 61010-2-040:2020)
Règles 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 (IEC 61010-2-040:2020)
IEC 61010-2-040:2020 est disponible sous forme de IEC 61010-2-040:2020 RLV qui contient la Norme internationale et sa version Redline, illustrant les modifications du contenu technique depuis l'édition précédente.
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).
Varnostne zahteve za električno opremo za meritve, nadzor in laboratorijsko uporabo - 2-040. del: Posebne zahteve za sterilizatorje in pralnike-dezinfektorje, ki se uporabljajo za obdelavo medicinskih materialov (IEC 61010-2-040:2020)
Ta del standarda IEC 61010 določa varnostne zahteve za električno opremo, namenjeno za sterilizacijo, pranje in razkuževanje medicinskih materialov v medicini, veterini, farmaciji in pri delu v laboratoriju, kadar je uporabljena pod okoljskimi pogoji iz točke 1.4.
Primeri take opreme vključujejo:
a) STERILIZATORJE in dezinfektorje na paro in/ali vročo vodo;
b) STERILIZATORJE in dezinfektorje na strupen plin, strupen aerosol ali strupene hlape;
c) STERILIZATORJE in dezinfektorje na vroč zrak ali vroč inertni plin; in
d) PRALNIKE-DEZINFEKTORJE.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-junij-2022
Nadomešča:
SIST EN 61010-2-040:2016
Varnostne zahteve za električno opremo za meritve, nadzor in laboratorijsko
uporabo - 2-040. del: Posebne zahteve za sterilizatorje in pralnike-dezinfektorje, ki
se uporabljajo za obdelavo medicinskih materialov (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)
Sicherheitsbestimmungen für elektrische Mess-, Steuer-, Regel- und Laborgeräte - Teil 2
-040: Besondere Anforderungen an Sterilisatoren und Reinigungs-Desinfektionsgeräte
für die Behandlung medizinischen Materials (IEC 61010-2-040:2020)
Règles 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 (IEC 61010-2-040:2020)
Ta slovenski standard je istoveten z: EN IEC 61010-2-040:2021
ICS:
11.080.10 Sterilizacijska oprema Sterilizing equipment
19.080 Električno in elektronsko Electrical and electronic
preskušanje testing
71.040.10 Kemijski laboratoriji. Chemical laboratories.
Laboratorijska oprema Laboratory equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD EN IEC 61010-2-040
NORME EUROPÉENNE
EUROPÄISCHE NORM
November 2021
ICS 19.080; 71.040.10 Supersedes EN 61010-2-040:2015 and all of its
amendments and corrigenda (if any)
English Version
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)
Exigences de sécurité pour appareils électriques de Sicherheitsbestimmungen für elektrische Mess-, Steuer-,
mesurage, de régulation et de laboratoire - Partie 2-040: Regel- und Laborgeräte - Teil 2-040: Besondere
Exigences particulières pour stérilisateurs et laveurs Anforderungen an Sterilisatoren und Reinigungs-
désinfecteurs utilisés pour traiter le matériel médical Desinfektionsgeräte für die Behandlung medizinischen
(IEC 61010-2-040:2020) Materials
(IEC 61010-2-040:2020)
This European Standard was approved by CENELEC on 2020-06-18. CENELEC members are bound to comply with the CEN/CENELEC
Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.
Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC
Management Centre or to any CENELEC member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the
same status as the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,
Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the
Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2021 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN IEC 61010-2-040:2021 E
European foreword
The text of document 66/699/CDV, future edition 3 of IEC 61010-2-040, prepared by IEC/TC 66
"Safety of measuring, control and laboratory equipment" was submitted to the IEC-CENELEC parallel
vote and approved by CENELEC as EN IEC 61010-2-040:2021.
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2022-05-26
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2024-11-26
document have to be withdrawn
This document supersedes EN 61010-2-040:2015 and all of its amendments and corrigenda (if any).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC shall not be held responsible for identifying any or all such patent rights.
This document has been prepared under a Standardization Request given to CENELEC by the
European Commission and the European Free Trade Association, and supports essential
requirements of EU Directive(s) / Regulation(s).
For relationship with EU Directive(s) / Regulation(s), see informative Annex ZZ, which is an integral
part of this document.
Any feedback and questions on this document should be directed to the users’ national committee. A
complete listing of these bodies can be found on the CENELEC website.
Endorsement notice
The text of the International Standard IEC 61010-2-040:2020 was approved by CENELEC as a
European Standard without any modification.
In the official version, for Bibliography, the following notes have to be added for the standards
indicated:
IEC 60335-2-4 NOTE Harmonized as EN 60335-2-4
IEC 60335-2-5 NOTE Harmonized as EN 60335-2-5
IEC 60335-2-7 NOTE Harmonized as EN 60335-2-7
IEC 60335-2-11 NOTE Harmonized as EN 60335-2-11
IEC 60335-2-58 NOTE Harmonized as EN 60335-2-58
IEC 60601-1:2005 NOTE Harmonized as EN 60601-1:2006 (not modified)
IEC 61010-2-010 NOTE Harmonized as EN IEC 61010-2-010
IEC 62061 NOTE Harmonized as EN 62061
IEC 62304 NOTE Harmonized as EN 62304
ISO 10472 (series) NOTE Harmonized as EN ISO 10472 (series)
ISO 12100:2010 NOTE Harmonized as EN ISO 12100:2010 (not modified)
ISO 13849 (series) NOTE Harmonized as EN ISO 13849 (series)
ISO 14971 NOTE Harmonized as EN ISO 14971
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments)
applies.
NOTE 1 Where an International Publication has been modified by common modifications, indicated by (mod),
the relevant EN/HD applies.
NOTE 2 Up-to-date information on the latest versions of the European Standards listed in this annex is available
here: www.cenelec.eu.
Annex ZA of EN 61010-1:2010/A1:2019 is applicable, with the following additions:
Publication Year Title EN/HD and IEC/ISO Year
IEC 61770 - Electric appliances connected to the water EN 61770 2009
mains — Avoidance of back-siphonage and
+A11 2018
failure of hose-sets
ISO 3585 - Borosilicate glass 3.3 — Properties ISO 3585 1998
ISO 4126-1 - Safety devices for protection against ISO 4126-1 2013
excessive pressure — Safety valves
ISO 4126-2 - Safety devices for protection against ISO 4126-2 2018
excessive pressure — Part 2: Bursting disc
safety devices
Annex ZZ
(informative)
Relationship between this European standard and the safety
objectives of Directive 2014/35/EU [2014 OJ L96] aimed to be
covered
This European Standard has been prepared under a Commission’s standardization request relating to
harmonized standards in the field of the Low Voltage Directive, M/511, to provide one voluntary means
of conforming to safety objectives of Directive 2014/35/EU of the European Parliament and of the
Council of 26 February 2014 on the harmonization of the laws of the Member States relating to the
making available on the market of electrical equipment designed for use within certain voltage limits
[2014 OJ L96].
Once this standard is cited in the Official Journal of the European Union under that Directive,
compliance with the normative clauses of this standard given in Table ZZ.1 confers, within the limits of
the scope of this standard, a presumption of conformity with the corresponding safety objectives of
that Directive, and associated EFTA regulations.
Table ZZ.1 — Correspondence between this European standard and Annex I of Directive
2014/35/EU [2014 OJ L96]
Safety objectives of Directive Clause(s) / sub-
Remarks / Notes
2014/35/EU (Annex I) clause(s) of this EN
1. General conditions
1 (a) the essential characteristics, the 5.1
recognition and observance of which will
5.2
ensure that electrical equipment will be
5.3
used safely and in applications for which it
5.4
was made, shall be marked on the
electrical equipment, or, if this is not
possible, on an accompanying document
1 (b) the electrical equipment, together 5.4
with its component parts, shall be made in
6.6
such a way as to ensure that it can be
6.10
safely and properly assembled and
6.11
connected
Annex F
1 (c) the electrical equipment shall be so 5.4
designed and manufactured as to ensure
Annex F
that protection against the hazards set out
17 (for hazards not
in points 2 and 3 is assured, providing that
covered by clauses 6-
the equipment is used in applications for
16)
which it was made and is adequately
See also the details in
maintained
points 2 and 3
Safety objectives of Directive Clause(s) / sub-
Remarks / Notes
2014/35/EU (Annex I) clause(s) of this EN
2. Protection against hazards arising from the electrical equipment
Measures of a technical nature shall be laid down in accordance with point 1, in order to ensure that:
2 (a) persons and domestic animals are 4, 6.1 – 6.11, 9.6,
adequately protected against the danger 11.6,14.4,
of physical injury or other harm which
Annex D,
might be caused by direct or indirect
Annex F,
contact
Annex K
2 (b) temperatures, arcs or radiation which 4, 4.4.4.2, 6.3.1.b) 2),
would cause a danger, are not produced
6.3.2 b) 2), 7.101,
7.102, 7.103, 7.104,
7.106, 7.109, 7.110,
9.5, 9.6, 11.102 i) and
j), 10.1 -10.5, 12
2 (c) persons, domestic animals and 4, 4.4, 7.2- 7.7, 7.101-
property are adequately protected against 7.110, 9, 11.101-
non-electrical dangers caused by the 11.104, 12.3, 12.5,
electrical equipment which are revealed 12.6, 13.1, 13.2,
by experience 13.101, 13.102, 16.2
2 (d) the insulation is suitable for 6.7, Annex K
foreseeable conditions
3. Protection against hazards which may be caused by external influences on the electrical
equipment
Technical measures shall be laid down in accordance with point 1, in order to ensure that the electrical
equipment:
3 (a) meets the expected mechanical 4, 7, 8
requirements in such a way that persons,
domestic animals and property are not
endangered
3 (b) is resistant to non-mechanical 1.4, 4, 6.7.2.2.1, 10.5,
influences in expected environmental 11.6,
conditions, in such a way that persons,
14.3, 14.8, 15
domestic animals and property are not
endangered
3 (c) does not endanger persons, 4, 7.110, 9, 11.7, 14,
domestic animals and property in 16.1
foreseeable conditions of overload
WARNING 1 — Presumption of conformity stays valid only as long as a reference to this European
standard is maintained in the list published in the Official Journal of the European Union. Users of this
standard should consult frequently the latest list published in the Official Journal of the European
Union.
WARNING 2 — Other Union legislation may be applicable to the product(s) falling within the scope of
this standard.
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
IEC 61010-2-040:2020 © IEC 2020 – 3 –
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 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.
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:
1.1.1 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 include the following:
a) STERILIZERS and disinfectors using steam and/or hot water as the sterilant;
b) STERILIZERS and disinfectors using toxic gas, toxic aerosol or toxic vapour as the sterilant;
c) STERILIZERS and disinfectors using hot air or hot inert gas as the sterilant; and
d) WASHER-DISINFECTORS.
1.1.2 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:
a) provided with not more than one connection to a particular supply MAINS; and
b) 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);
– 6 – IEC 61010-2-040:2020 © IEC 2020
cc) laundry equipment (see IEC 60335-2-4, IEC 60335-2-7, IEC 60335-2-11, and
ISO 10472 (all parts)), unless designed for disinfecting medical materials;
dd) dishwashers (see IEC 60335-2-5 and IEC 60335-2-58).
1.2.1 Aspects included in scope
Replacement:
Replace item g) with the following new text:
g) liberated gases (including the non-intentional escape of toxic gas), pathogenic
substances, explosion and implosion (see Clause 13).
1.2.2 Aspects excluded from scope
Addition:
Add the following two new items:
aa) special requirements for protection against chemical and high-risk micro-biological
HAZARDS associated with the LOAD;
PRESSURE VESSELS.
bb) general requirements for the design of calorifiers, shell boilers and
NOTE National and other regulations or codes apply for the safety of calorifiers, shell boilers and
PRESSURE VESSELS (see 14.101).
2 Normative references
This clause of Part 1 is applicable except as follows:
Addition:
Add the following new references:
IEC 61770, Electric appliances connected to the water mains – Avoidance of backsiphonage
and failure of hose-sets
ISO 3585, Borosilicate glass 3.3 – Properties
ISO 4126-1, Safety devices for protection against excessive pressure – Part 1: Safety valves
ISO 4126-2, Safety devices for protection against excessive pressure – Part 2: Bursting disc
safety devices
3 Terms and definitions
This clause of Part 1 is applicable except as follows:
3.2 Parts and accessories
Addition:
Add the following new terms and definitions:
3.2.101
CHAMBER
LOAD
part of the equipment which receives the
IEC 61010-2-040:2020 © IEC 2020 – 7 –
3.2.102
LOAD
equipment or materials put into a CHAMBER to be processed through an OPERATING CYCLE
3.2.103
STERILIZER
equipment designed to achieve sterilization which comprises a series of actions or operations
needed to achieve the specified requirements for sterility
3.2.104
PRESSURE VESSEL
assembly comprising the CHAMBER, the jacket (if fitted), doors, and all other components in
permanent open connection with the CHAMBER
Note 1 to entry: The PRESSURE VESSEL does not include parts from which it can be isolated, such as steam
generators, pipework, and fittings.
3.2.105
OPERATING CYCLE
complete set of stages of the process that is carried out in a specified sequence
Note 1 to entry: Loading and unloading are not part of the OPERATING CYCLE.
3.2.106
WASHER-DISINFECTOR
equipment intended to clean and disinfect medical devices and other articles used in the
context for example of medical, dental, pharmaceutical and veterinary practice
3.5 Safety terms
3.5.2
HAZARD
Addition:
Add the following new Note 1 to entry:
Note 1 to entry: In the context of this document, the term HAZARD relates only to potential sources of harm to the
OPERATOR and surroundings (see 1.2.1), and does not include potential sources of harm related to the efficacy of
the process.
3.5.11
OPERATOR
Addition:
Add the following Note 1 to entry:
Note 1 to entry: An OPERATOR includes persons installing, operating, adjusting, maintaining, cleaning, repairing or
moving equipment.
4 Tests
This clause of Part 1 is applicable except as follows:
4.3.2.4 Covers and removable parts
Addition:
Add the following new second paragraph:
– 8 – IEC 61010-2-040:2020 © IEC 2020
Covers including panels and control box ENCLOSURES which do not require the use of a TOOL
for removal need not be removed if they have interlocks which meet the requirements of
Clause 15, and which automatically de-activate all parts which would otherwise present a
HAZARD when the cover is opened.
4.3.2.12 Duty cycle
Addition:
Add the following new second paragraph:
Equipment which can be operated continuously shall also be tested without any interval
between consecutive OPERATING CYCLES.
Addition:
Add the following new subclause:
4.3.2.101 Non-electrical supplies and services
Non-electrical supplies and services shall be set to the least favourable RATED settings.
4.4.2.1 General
Replacement:
Replace the first sentence of the first paragraph with the following sentence:
Fault conditions shall include those specified in 4.4.2.2 to 4.4.2.14 and 4.4.2.101 to 4.4.2.103.
4.4.2.5 Motors
Addition:
Add the following new second paragraph:
If it is impracticable to test a motor when installed, a separate identical motor can be tested
but it shall be tested in the same conditions that exist inside the equipment.
4.4.2.13 Interlocks
Addition:
Add the following new second paragraph:
If an interlock provides protection against accidental contact with a hazardous substance, the
interlock is tested using a non-hazardous substance.
Addition:
Add the following three new subclauses:
4.4.2.101 Pressure controllers
Pressure controllers, except for overpressure safety devices meeting the requirements of
11.7.4, shall be overridden to supply the service continuously.
IEC 61010-2-040:2020 © IEC 2020 – 9 –
4.4.2.102 Failure, or partial failure, of the MAINS supply
The equipment shall be operated at 90 % and 110 % of the RATED voltage for one cycle. The
voltage shall then be set to 90 % of the RATED voltage for 5 min. The voltage shall then be
reduced gradually at a rate of approximately 10 V per min until the equipment fails to operate
normally. The voltage shall then be reset to the RATED voltage with the equipment still
switched on.
4.4.2.103 Failure, or partial failure, of other supplies and services
In turn, each non-electrical supply and service shall be interrupted, or partially interrupted,
whichever is less favourable.
NOTE Examples include air, steam, feedwater, sterilant gas, detergent, disinfectant, and systems for drainage,
exhaust, and ventilation.
5 Marking and documentation
This clause of Part 1 is applicable except as follows:
5.1.2 Identification
Replacement:
Replace the existing text by the following:
The equipment shall as a minimum be marked with the following:
a) the name and address of the manufacturer;
b) any additional markings required by national and local regulations, including the name and
address of the manufacturer's authorized representative in the country of intended use;
c) a marking that uniquely identifies the individual unit of manufacture such as a serial
number;
d) year and place of manufacture, if different from manufacturer's address;
e) model identification;
f) designated purpose of the equipment.
Conformity is checked by inspection
Addition:
Add the following two new subclauses:
5.1.101 Overpressure protective device
The device (see 11.7.4) shall be marked with the name of the manufacturer of the device, the
model number, and the pressure to which it is set. If a bursting disc is located between the
CHAMBER and the overpressure safety device, the disc shall be marked with its specified
bursting pressure and associated temperature.
NOTE National, local regulations and other codes can apply.
5.1.102 PRESSURE VESSELS and shell boilers
Attention is drawn to the existence of national and local regulations that can require additional
markings.
– 10 – IEC 61010-2-040:2020 © IEC 2020
5.2 Warning markings
Addition:
Add the following new second paragraph:
Warning and caution symbols shall be at least 10 mm high.
5.4.1 General
Replacement:
Replace the first paragraph (excluding lettered list) by the following new paragraph:
The following documentation necessary for safety purposes, as needed by the OPERATOR or
RESPONSIBLE BODY, shall be marked with its date of issue or revision status and be provided
with the equipment:
Add the following new paragraph after item h) of the lettered list:
If NORMAL USE involves the handling of a hazardous substance, documentation shall include
information on constituents, correct storage, use, and safe disposal.
Replace Note 2 by the following new Note 2:
NOTE 2 Attention is drawn to the existence of national and local regulations that can apply to the documentation.
Add a new paragraph directly before the conformity statement:
Marking, information, and language shall:
1) comply with regulations applying in the country of intended use;
NOTE 3 ISO 15223-2 offers guidance for equipment classified as a medical device.
2) include instructions for the disposal of the equipment, its accessories and its packaging;
3) give due consideration to the technical knowledge, education and training of different
OPERATOR categories;
4) not contradict information contained in documentation provided to describe the equipment.
5.4.2 Equipment RATINGS
Addition:
Add the following new item to the lettered list after item f):
aa) for each non-electrical service, if applicable, the RATED ranges of temperature,
pressure and flow-rate.
5.4.3 Equipment installation
Replacement:
Replace items a) to g) with the following:
a) location and mounting instructions;
b) space required for safe and efficient maintenance;
c) individual weights of principal heavy subassemblies;
IEC 61010-2-040:2020 © IEC 2020 – 11 –
d) overall weight and floor loading requirements;
e) unpacking and assembly instructions (see also 7.108);
f) MAINS supply requirements and connections, including the temperature rating of any cable
required to meet the requirements in 5.1.8;
g) for PERMANENTLY CONNECTED EQUIPMENT:
1) supply wiring requirements;
2) requirements for any external switch or circuit-breaker (see 6.11.3.1) and external
overcurrent protection devices (see 9.6.1) and a recommendation that the switch or
circuit-breaker be near the equipment;
h) ventilation requirements (see 11.101, 13.1.103.1, and 13.1.101);
i) drainage requirements (see 11.101);
j) instructions for protective earthing;
k) instructions relating to sound level (see 12.5.1);
l) requirements for special services, for example air, feedwater, cooling liquid;
m) requirements related to hazardous gas atmospheres (see Clause 13);
n) instructions to position the equipment so that it is not difficult to operate the disconnecting
device;
o) instructions relating to the handling and containment of hazardous substances, including
any need for additional equipment that can be required to control emissions (see 13.1);
HAZARDS caused by liquids or hot items falling from the equipment
p) instructions relating to
(see 9.1);
q) requirements for material used in the installation of the equipment and which can come
into contact with sterilant (see 13.1.103.4 and 13.2.101);
r) instructions for ambient illumination (see also 11.102);
NOTE ISO 12100 and EN 1837 give guidance on lighting.
s) instructions relating to heat emission.
Addition:
Add the following new subclause:
5.4.3.101 Special systems
Installation instructions shall include details of the following special systems, if needed to
protect against possible HAZARDS:
a) non-recirculating ventilation system for the room in which the equipment is installed (also
see 13.1.103.3);
Such a ventilation system shall normally give a minimum of 10 air changes per hour, but
for large installations this may need to be increased.
b) for equipment using toxic sterilant, means to protect against HAZARDS arising from failure
of the room ventilation system (see 13.1.103.3);
c) a non-recirculating local exhaust system to remove fugitive emissions (see 13.1.101.4);
d) a drainage system (see 13.1.101.3);
e) a venting system for the drain (see 13.1.101.3);
f) a CHAMBER exhaust system (see 13.1.101.2);
g) a system used to control escaping biological emissions (see 13.1.104);
h) any other supply, for example sterilant, steam, compressed air, hot or cold water
(including instructions on the prevention of backsiphonage (see 11.104).
– 12 – IEC 61010-2-040:2020 © IEC 2020
Conformity is checked by inspection.
5.4.4 Equipment operation
Replacement:
Replace items a) to j) with the following:
a) identification of operating controls and their use in all operating modes;
b) an instruction not to position the equipment so that it is difficult to operate the
disconnecting device;
c) instructions for interconnection to accessories and other equipment, including details of
suitable accessories, detachable parts and any special materials;
d) specification of limits for intermittent operation;
e) an explanation of symbols related to safety which are used on the equipment (see 5.2);
f) instructions for cleaning (see 11.2);
g) instructions for making the equipment safe after an incomplete OPERATING CYCLE;
closure prevention device
h) instructions for the correct use of the lockable door
(see 7.102 b));
i) instructions to the RESPONSIBLE BODY for safe access to the LOAD in the CHAMBER in the
event of a fault (see 13.1.102);
j) instructions for action in case of a malfunction, including fault diagnosis;
NOTE 1 These instructions can include any special methods of interpreting data recorded or noted during the
OPERATING CYCLE, to detect failure or trends that can lead to failure, for example the use of a temperature
recorder.
k) loading procedure;
l) instructions for safe disposal of parts such as detergent containers, sterilant containers
and parts contaminated by pathogenic material;
NOTE 2 Additional requirements on methods of disposal can be specified by national or local authorities.
m) instructions for testing the function of critical safety devices in a safe manner, for example
overpressure safety devices (see 11.7.4);
n) if NORMAL USE involves the handling of substances, instructions on correct use and safety
provisions. In addition, instructions shall be given on methods of safe handling before
disposal, and recommendations on disposal (also see Note 2 above);
o) details of methods of reducing burn HAZARDS from surfaces permitted to exceed the
temperature limits specified in Table 19;
p) guidelines to be followed in cases of emergency in which eye or skin contact or inhalation
could occur, such as release of toxic material or pathogenic material, or leakage from a
sterilizing agent container or disinfectant container or enzymatic, alkaline or acidic
detergent container;
These guidelines shall also be prominently displayed on or near the equipment
q) instructions for safely replenishing containers of dosing chemicals (see 13.102);
r) if a HAZARD could result from the use of equipment with a type of LOAD other than those for
which it is intended, there shall be an appropriate warning in the instructions, and a
warning marking (see 5.2) shall state the types of LOAD which can be used. If small
equipment has insufficient space for this warning marking, symbol 14 of Table 1 shall be
marked;
s) instructions for inspection, replenishment, and storage of consumable materials which
could cause a HAZARD, including details of HAZARDS which could arise from the introduction
of incorrect quantities of recommended consumable materials, also procedures and details
of the protection needed to minimize such HAZARDS;
IEC 61010-2-040:2020 © IEC 2020 – 13 –
t) identification of residual RISKS and instructions on necessary protective procedures
(see Clause 17).
5.4.5 Equipment maintenance and service
Replacement:
Replace the existing text with the following new text:
Instructions shall be provided to the RESPONSIBLE BODY in sufficient detail to permit safe
maintenance, inspection and testing of the equipment and to ensure continued safety of the
equipment after the maintenance, inspection and test procedure.
Instructions shall include:
a) details of maintenance required on parts subject to wear and tear if failure could lead to a
HAZARD;
b) inspection and replacement, if necessary, of any hoses/pipes or other parts containing
fluids, if their failure could cause a HAZARD;
c) details of safety devices fitted together with their settings and replacement procedures;
d) procedures for making the equipment safe prior to maintenance;
e) maintenance schedules and repair procedures, including ambient lighting level
(see 11.102) and any special precautions necessary to protect against HAZARDS during
maintenance;
f) methods of safe handling for repair or disposal of any part containing or contaminated by
toxic and/or pathogenic material;
NOTE 1 Requirements on methods of disposal can be specified by national or local authorities.
NOTE 2 Aspects of environmental impact are addressed in ISO 14971 and in applicable parts of IEC 61508.
g) battery types for equipment using replaceable batteries;
h) RATINGS and characteristics of replaceable fuses;
i) a list of parts (if any), restricted to examination and/or supply by the manufacturer or the
manufacturer's agent;
j) residual RISKS (see Clause 17) and protective measures for these RISKS;
k) verification of the safe state of the equipment after repair.
Conformity is checked by inspection.
Addition:
Add the following two new subclauses:
5.4.101 OPERATOR training
5.4.101.1 General
In order that OPERATORS be adequately trained in the safe use of the equipment, the
manufacturer's instructions shall state that the RESPONSIBLE BODY should ensure:
a) that all personnel who operate or maintain the equipment are trained in its operation and
in its safe use;
b) that, if exposure limits (i.e. short-term exposure limit (STEL) or long-term exposure limit
(LTEL)) or permissible working environmental concentration limit (see the notes to 13.1)
could be exceeded during NORMAL USE, personnel working with toxic chemicals, gases,
and vapours are given comprehensive instructions in the process. These instructions
– 14 – IEC 61010-2-040:2020 © IEC 2020
include information on relevant health HAZARDS, national regulations, methods for safe
use, and methods to detect escape of the agent;
c) that there is regular training of all personnel concerned with the operation and
maintenance of the equipment, including emergency procedures for any toxic, flammable,
explosive or pathogenic material released into the environment. Records of attendance at
training are maintained, and evidence of understanding demonstrated.
Also see 7.3.2 b).
Conformity is checked by inspection.
5.4.101.2 Procedures for poten
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