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)
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.
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
SIST EN IEC 61010-2-040:2022
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
SIST EN IEC 61010-2-040:2022 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN IEC 61010-2-040:2022
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SIST EN IEC 61010-2-040:2022
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
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SIST EN IEC 61010-2-040:2022
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)
2
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SIST EN IEC 61010-2-040:2022
EN IEC 61010-2-040:2021 (E)
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
3
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SIST EN IEC 61010-2-040:2022
EN IEC 61010-2-040:2021 (E)
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
4
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SIST EN IEC 61010-2-040:2022
EN IEC 61010-2-040:2021 (E)
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
5
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SIST EN IEC 61010-2-040:2022
EN IEC 61010-2-040:2021 (E)
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.
6
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SIST EN IEC 61010-2-040:2022
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
Warning! Make sure that you obtained this publication from an authorized distributor.
Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agréé.
® Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale
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SIST EN IEC 61010-2-040:2022
– 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
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SIST EN IEC 61010-2-040:2022
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;
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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.
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SIST EN IEC 61010-2-040:2022
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);
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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
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SIST EN IEC 61010-2-040:2022
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:
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SIST EN IEC 61010-2-040:2022
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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 conti
...
SLOVENSKI STANDARD
oSIST prEN IEC 61010-2-040:2019
01-december-2019
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
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
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
Ta slovenski standard je istoveten z: prEN IEC 61010-2-040:2019
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
oSIST prEN IEC 61010-2-040:2019 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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66/699/CDV
COMMITTEE DRAFT FOR VOTE (CDV)
PROJECT NUMBER:
IEC 61010-2-040 ED3
DATE OF CIRCULATION: CLOSING DATE FOR VOTING:
2019-10-04 2019-12-27
SUPERSEDES DOCUMENTS:
66/696/RR
IEC TC 66 : SAFETY OF MEASURING, CONTROL AND LABORATORY EQUIPMENT
SECRETARIAT: SECRETARY:
United Kingdom Mr David Hyde
OF INTEREST TO THE FOLLOWING COMMITTEES: PROPOSED HORIZONTAL STANDARD:
SC 62D
Other TC/SCs are requested to indicate their interest, if
any, in this CDV to the secretary.
FUNCTIONS CONCERNED:
EMC ENVIRONMENT QUALITY ASSURANCE SAFETY
SUBMITTED FOR CENELEC PARALLEL VOTING NOT SUBMITTED FOR CENELEC PARALLEL VOTING
Attention IEC-CENELEC parallel voting
The attention of IEC National Committees, members of
CENELEC, is drawn to the fact that this Committee Draft
for Vote (CDV) is submitted for parallel voting.
The CENELEC members are invited to vote through the
CENELEC online voting system.
This document is still under study and subject to change. It should not be used for reference purposes.
Recipients of this document are invited to submit, with their comments, notification of any relevant patent rights of
which they are aware and to provide supporting documentation.
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
PROPOSED STABILITY DATE: 2023
NOTE FROM TC/SC OFFICERS:
This CDV is intended only to align IEC 61010-2-040:2015 with IEC 61010-1:2010 and its amendment
1:2016 and provide minor editorial corrections. With this revision IEC 61010-2-040 will be in line with
Copyright © 2019 International Electrotechnical Commission, IEC. All rights reserved. It is permitted to
download this electronic file, to make a copy and to print out the content for the sole purpose of preparing National
Committee positions. You may not copy or "mirror" the file or printed version of the document, or any part of it, for
any other purpose without permission in writing from IEC.
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the latest requirements of IEC 61010-1 + A1.
This document contains no technical changes to already accepted base documents (IEC 61010-1:2010
and its amendment 1:2016 and IEC 61010-2-040:2015) but two;
1. Clause 6.8.3.1 is modified because otherwise it would need a specific European deviation in order to
be harmonised to the LVD 2014/35/EU (ref. NAC assessment of IEC 61010-1/A1).
2. In 15.1 as an alternative method, for interlock systems containing electric/electronic or
programmable components (E/E/P components) the reliability and design requirements can be
determined by applying, for example IEC 62061 (SIL) or ISO 13849 (PL).
Further technical development is reserved for a new amendment or edition to be initiated separately as
necessary.
This alignment is realised as a new 3rd edition of IEC 61010-2-040 simply because of document
control; the previous edition 2.0 is based on the third edition of IEC 61010-1:2010 (without the
Amendment 1:2016) and amending it to incorporate the contents of IEC 61010-1 Amendment 1 would
need an unnecessary repeating of the requirements in that amendment 1 that are not particular for the
equipment in the scope of IEC 61010-2-040 . Furthermore, technically, one would need to follow 4
documents in parallel to get the full text of this part 2 (61010-1:2010, 61010-1 A1:2016, 61010-2-
040:2015, and 61010-2-040 A1).With this approach, and when the consolidated version of IEC 61010-
1:2010/A1:2016 conveniently is published, only two documents are needed.
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1 CONTENTS
2 FOREWORD . 6
3 1 Scope and object . 8
4 1.1.1Equipment included in scope . 8
5 1.1.2Equipment excluded from scope . 8
6 1.2.1Aspects included in scope . 9
7 1.2.2Aspects excluded from scope . 9
8 2 Normative references . 9
9 3 Terms and definitions . 9
10 4 Tests . 10
11 4.3.2.4Covers and removable parts . 10
12 4.3.2.12Duty cycle . 11
13 4.3.2.101Non-electrical supplies and services . 11
14 4.4.2.1General . 11
15 4.4.2.5Motors . 11
16 4.4.2.13Interlocks . 11
17 4.4.2.101Pressure controllers . 11
18 4.4.2.102Failure, or partial failure, of the MAINS supply . 12
19 4.4.2.103Failure, or partial failure, of other supplies and services . 12
20 5 Marking and documentation . 12
21 5.1.2Identification . 12
22 5.1.101Overpressure safety device . 12
23 5.1.102PRESSURE VESSELS and shell boilers . 12
24 5.2Warning markings . 13
25 5.4.1General . 13
26 5.4.2Equipment ratings. 13
27 5.4.3Equipment installation . 13
28 5.4.3.101Special systems . 14
29 5.4.4Equipment operation . 15
30 5.4.5Equipment maintenance and service . 16
31 5.4.101OPERATOR training . 16
32 5.4.101.1General . 16
33 5.4.101.2Procedures for potentially hazardous actions . 17
34 6 Protection against electric shock . 17
35 6.2.2Examination . 17
36 6.8.3.1The a.c. voltage test . 17
37 6.9.2Insulating materials . 17
38 7 Protection against mechanical HAZARDS . 17
39 7 Protection against mechanical HAZARDS and against HAZARDS related to
40 mechanical functions . 18
41 7.1General . 18
42 7.4Stability . 18
43 7.5.101Transfer of LOADS into and out of the CHAMBER. 18
44 7.101Doors, conveyors, etc . 18
45 7.102 Access to the CHAMBER . 19
46 7.103 Prevention of entry of gases, steam or liquids . 19
47 7.104 Prevention of new OPERATING CYCLE . 19
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48 7.105 Pressure-retaining parts of a door . 20
49 7.106 Doors of equipment for use with fluids in containers . 20
50 7.107Double-ended equipment . 20
51 7.108Transport and packaging . 21
52 7.109Guards and panelling . 21
53 7.110Emergency shut-down device . 21
54 8 Mechanical resistance to shock and impact . 22
55 9 Protection against the spread of fire . 22
56 9.1 General . 22
57 9.5.101Requirements for equipment containing or using flammable gases . 22
58 10 Equipment temperature limits and resistance to heat . 23
59 10.1Surface temperature limits for protection against burns . 23
60 10.3Other temperature measurements . 23
61 10.5.101Other materials . 23
62 11 Protection against HAZARDS from fluids and solid foreign objects . 24
63 11.1General . 24
64 11.7.2Leakage and rupture at high pressure . 24
65 11.7.4Overpressure safety device . 24
66 11.101Discharge to atmosphere . 25
67 11.102Instruments and indicating devices . 25
68 11.103Protection of hot and cold water services . 26
69 11.104Equipment with inflatable or pressure-activated seals . 26
70 12 Protection against radiation, including laser sources, and against sonic and
71 ultrasonic pressure . 26
72 12.5Sonic and ultrasonic pressure . 27
73 12.5.1Sound level . 27
74 13 Protection against liberated gases, substances, explosion and implosion . 27
75 13.1Poisonous and injurious gases and substances . 27
76 13.1.101CHAMBER discharge systems . 28
77 13.1.101.1Discharge from the CHAMBER . 28
78 13.1.101.2Failure of a CHAMBER exhaust system . 28
79 13.1.101.3Protection from gases liberated from a drain . 28
80 13.1.101.4Local exhaust ventilation . 29
81 13.1.102LOAD access after a fault . 29
82 13.1.103HAZARDS arising from the use of toxic sterilant . 29
83 13.1.103.1CHAMBER leakage . 29
84 13.1.103.2Protection against gases liberated from the LOAD . 29
85 13.1.103.3Failure of room ventilation system . 30
86 13.1.103.4Materials in contact with sterilant . 30
87 13.1.104Pathogenic substances . 30
88 13.2Explosion and implosion . 30
89 13.2.101Materials in contact with sterilant . 30
90 13.2.102Explosion, implosion and fire of toxic gas sterilizers. 31
91 13.2.102.1Flammable sterilants . 31
92 13.2.102.2Heating of flammable liquid sterilant . 31
93 13.101Other HAZARDS arising from the use of toxic sterilants . 31
94 13.101.1Opening or disconnecting a sterilant supply system . 32
95 13.101.2Gas blending . 32
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96 13.101.3Sterilant supply . 32
97 13.101.4Supply from sterilant cartridges. 32
98 13.101.5Isolation of any part of the sterilant supply system . 32
99 13.101.6Failure of a sterilant supply control system . 32
100 13.102Chemical dosing systems . 33
101 14 Components . 33
102 14.101PRESSURE VESSELS and shell boilers . 33
103 14.102Access ports . 33
104 14.103Control systems . 33
105 14.104Microprocessors . 34
106 14.105Asbestos. 34
107 15 Protection by interlocks . 34
108 16 HAZARDS resulting from application . 34
109 17 RISK assessment . 35
110 Annexes . 36
111 Annex G (informative) Leakage and rupture from fluids under pressure . 36
112 Annex L (informative) Index of defined terms . 37
113 Bibliography . 38
114
115
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116 INTERNATIONAL ELECTROTECHNICAL COMMISSION
117 ____________
118
119 SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR
120 MEASUREMENT, CONTROL, AND LABORATORY USE –
121
122 Part 2-040: Particular requirements for sterilizers and
123 washer-disinfectors used to treat medical materials
124
125 FOREWORD
126 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
127 all national electrotechnical committees (IEC National Committees). The object of IEC is to promote
128 international co-operation on all questions concerning standardization in the electrical and electronic fields. To
129 this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,
130 Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC
131 Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested
132 in the subject dealt with may participate in this preparatory work. International, governmental and non-
133 governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely
134 with the International Organization for Standardization (ISO) in accordance with conditions determined by
135 agreement between the two organizations.
136 2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
137 consensus of opinion on the relevant subjects since each technical committee has representation from all
138 interested IEC National Committees.
139 3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
140 Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
141 Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
142 misinterpretation by any end user.
143 4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
144 transparently to the maximum extent possible in their national and regional publications. Any divergence
145 between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
146 the latter.
147 5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
148 assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
149 services carried out by independent certification bodies.
150 6) All users should ensure that they have the latest edition of this publication.
151 7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
152 members of its technical committees and IEC National Committees for any personal injury, property damage or
153 other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
154 expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
155 Publications.
156 8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
157 indispensable for the correct application of this publication.
158 9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of
159 patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
160 International Standard IEC 61010-2-040 has been prepared by IEC technical committee 66:
161 Safety of measuring, control and laboratory equipment.
162 This third edition cancels and replaces the second edition published in 2015. This edition
163 constitutes a technical revision.
164 This edition includes the following significant technical changes with respect to the previous
165 edition:
166 a) It is established on the basis of the third edition (2010) of IEC 61010-1 and its amendment
167 1 (2016)
168 b) Adaptation of text changes introduced by Amendment 1 of IEC 61010-1:2010;
169 c) Added tolerance for stability of a.c. voltage test equipment to Clause 6.8.3.1;
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170 The text of this standard is based on the following documents:
FDIS Report on voting
66/xxx/FDIS 66/xxx/RVD
171
172 Full information on the voting for the approval of this International Standard can be found in
173 the report on voting indicated in the above table.
174 This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
175 A list of all parts in the IEC 61010 series, published under the general title Safety
176 requirements for electrical equipment for measurement, control, and laboratory use, can be
177 found on the IEC website.
178 This Part 2-040 is intended to be used in conjunction with the latest edition of IEC 61010-1. It
179 was established on the basis of the third edition (2010) of IEC 61010-1 and its amendment 1
180 (2016), hereinafter referred to as Part 1.
181 This Part 2-040 supplements or modifies the corresponding clauses in Part 1 so as to convert
182 that publication into the IEC standard: Particular requirements for sterilizers and washer-
183 disinfectors used to treat medical materials.
184 Where a particular subclause of Part 1 is not mentioned in this Part 2-040, that subclause
185 applies as far as is applicable. Where this Part 2-040 states “addition”, “modification”,
186 “replacement”, or “deletion”, the relevant requirement, test specification or note in Part 1 shall
187 be adapted accordingly.
188 In this standard:
189 1) the following print types are used:
190 – requirements: in roman type;
191 – NOTES: in small roman type;
192 – conformity and tests: in italic type;
193 – terms used throughout this standard which have been defined in Clause 3: SMALL
194 ROMAN CAPITALS.
195 2) subclauses, figures, and tables which are additional to those in Part 1 are numbered
196 starting from 101; additional annexes are lettered starting from AA and additional list
197 items are lettered from aa).
198 The committee has decided that the contents of this publication will remain unchanged until
199 the stability date indicated on the IEC website under "http://webstore.iec.ch" in the data
200 related to the specific publication. At this date, the publication will be
201 • reconfirmed,
202 • withdrawn,
203 • replaced by a revised edition, or
204 • amended.
205
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206 SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR
207 MEASUREMENT, CONTROL, AND LABORATORY USE –
208
209 Part 2-040: Particular requirements for sterilizers and
210 washer-disinfectors used to treat medical materials
211
212
213
214 1 Scope and object
215 This clause of Part 1 is applicable except as follows:
216 1.1.1 Equipment included in scope
217 Replacement:
218 Replace the existing text with the following:
219 This part of IEC 61010 specifies safety requirements for electrical equipment intended for
220 sterilization, washing, and disinfection of medical materials in the medical, veterinary,
221 pharmaceutical and laboratory fields, when used under the environmental conditions of 1.4.
222 Examples of such equipment include the following:
223 a) sterilizers and disinfectors using steam, and/or hot water as the sterilant;
224 b) sterilizers and disinfectors using toxic gas, toxic aerosol or toxic vapour as the sterilant;
225 c) sterilizers and disinfectors using hot air or hot inert gas as the sterilant; and
226 d) washer disinfectors.
227 1.1.2 Equipment excluded from scope
228 Addition:
229 Add the following note to item f):
230 NOTE IEC 60601-1 defines medical electrical equipment as follows:
231 Electrical equipment, provided with not more than one connection to a particular supply MAINS and intended by its
232 manufacturer to be used in the diagnosis, treatment, or monitoring of a patient; and that makes physical or
233 electrical contact with the patient or transfers energy to or from the patient or detects such energy transfer to or
234 from the patient.
235 Addition:
236 Add the following new second paragraph:
237 This part of IEC 61010 does not apply to the following types of equipment:
238 aa) equipment for use in hazardous atmospheres (see IEC 60079) but does apply to an
239 atmosphere created inside equipment by a flammable sterilizing agent (see 13.0);
240 bb) laboratory equipment for the heating of materials for other purposes than sterilization or
241 disinfection (see IEC 61010-2-010);
242 cc) laundry equipment (see IEC 60335-2-4, IEC 60335-2-7, IEC 60335-2-11, and
243 ISO 10472), unless designed for disinfecting medical materials;
244 dd) dishwashers (see IEC 60335-2-5 and IEC 60335-2-58).
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245 1.2.1 Aspects included in scope
246 Replacement:
247 Replace item g) with the following new text:
248 g) liberated gases (including the non-intentional escape of toxic gas), pathogenic
249 substances, explosion and implosion (see Clause 13).
250 1.2.2 Aspects excluded from scope
251 Addition:
252 Add the following two new items:
253 aa) special requirements for protection against chemical and high-risk micro-biological
254 HAZARDS associated with the LOAD;
255 bb) general requirements for the design of calorifiers, shell boilers and PRESSURE VESSELS.
256 NOTE National and other regulations or codes apply for the safety of calorifiers, shell boilers and
257 (see 14.101).
PRESSURE VESSELS
258 2 Normative references
259 This clause of Part 1 is applicable except as follows:
260 Addition:
261 Add the following new references:
262 IEC 61770, Electric appliances connected to the water mains — Avoidance of back-siphonage
263 and failure of hose-sets
264 ISO 3585, Borosilicate glass 3.3 — Properties
265 ISO 4126-1, Safety devices
...
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