EN IEC 61010-2-040:2021
(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
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 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
Exigences de sécurité pour appareils électriques de mesurage, de régulation et de laboratoire - Partie 2-040: Exigences particulières pour stérilisateurs et laveurs désinfecteurs utilisés pour traiter le matériel médical
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
...
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