SIST EN 61010-2-040:2016

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 61010-2-040:2015)

It 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 61010-2-040:2015)

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 61010-2-040:2015)

L'IEC 61010-2-040:2015 définit les règles de sécurité pour les appareils électriques destinés à la stérilisation, au lavage et à la désinfection des matériaux médicaux dans les domaines médicaux, vétérinaires, pharmaceutiques et de laboratoire, lorsqu'ils sont utilisés dans les conditions d'environnement de 1.4. Elle a le statut d'une publication groupée de sécurité, conformément au Guide 104 de l'IEC. Cette deuxième édition annule et remplace la première édition parue en 2005. Cette édition constitue une révision technique. Cette édition inclut les modifications techniques majeures suivantes par rapport à l'édition précédente:
a) un nouvel article (4.3.2.101) a été ajouté pour les services et alimentations non électriques;
b) des exigences supplémentaires ont été ajoutées pour le marquage et la documentation (Article 5);
c) des exigences supplémentaires ont été incluses pour la protection contre les DANGERS mécaniques (Article 7);
d) des exigences supplémentaires ont été incluses pour la protection contre les radiations, y compris les sources laser, et contre la pression acoustique et ultra-sonique (Article 12).

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 61010-2-040:2015)

Ta standard 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 takšne opreme vključujejo naslednje: a) sterilizatorje in dezinfektorje z uporabo pare in/ali vroče vode kot sredstva za sterilizacijo; b) sterilizatorje in dezinfektorje z uporabo strupenega plina, strupenega aerosola ali strupenega hlapa kot sredstva za sterilizacijo; c) sterilizatorje in dezinfektorje z uporabo vročega zraka ali vročega inertnega plina kot sredstva za sterilizacijo; in d) pralnike-dezinfektorje.

General Information

• Status: Withdrawn
• Publication Date: 22-Feb-2016
• Withdrawal Date: 05-Nov-2024
• ICS: 11.080.10 - Sterilizing equipment
• ICS: 19.080 - Electrical and electronic testing
• ICS: 71.040.10 - Chemical laboratories. Laboratory equipment
• Technical Committee: MOV - Measuring equipment for electromagnetic quantities
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 05-Nov-2024
• Due Date: 28-Nov-2024
• Completion Date: 06-Nov-2024
• Ref Project: EN 61010-2-040:2015 - Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-040 Particular requirements for sterilizers and washer-disinfectors used to treat medical materials

Relations

• Replaced By: SIST EN IEC 61010-2-040:2022 - 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)
• Effective Date: 30-Nov-2021

Standards Content (Sample)

SLOVENSKI STANDARD
01-april-2016
1DGRPHãþD
SIST EN 61010-2-040:2006
9DUQRVWQH]DKWHYH]DHOHNWULþQRRSUHPR]DPHULWYHQDG]RULQODERUDWRULMVNR
XSRUDERGHO3RVHEQH]DKWHYH]DVWHULOL]DWRUMHLQSUDOQLNHGH]LQIHNWRUMHNL
VHXSRUDEOMDMR]DREGHODYRPHGLFLQVNLKPDWHULDORY,(&
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 61010-2-040:2015)
Sicherheitsbestimmungen für elektrische Mess-, Steuer-, Regel- und Laborgeräte - Teil 2
-040: Besondere Anforderungen an Sterilisatoren und Reinigungs-Desinfektionsgeräte
für die Behandlung medizinischen Materials (IEC 61010-2-040:2015)
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 61010-2-040:2015)
Ta slovenski standard je istoveten z: EN 61010-2-040:2015
ICS:
11.080.10 Sterilizacijska oprema Sterilizing equipment
19.080 (OHNWULþQRLQHOHNWURQVNR Electrical and electronic
SUHVNXãDQMH 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 61010-2-040

NORME EUROPÉENNE
EUROPÄISCHE NORM
September 2015
ICS 19.080; 71.040.10 Supersedes EN 61010-2-040:2005
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 61010-2-040:2015)
Règles de sécurité pour appareils électriques de mesurage, Sicherheitsbestimmungen für elektrische Mess-, Steuer-,
de régulation et de laboratoire - Partie 2-040: Exigences Regel- und Laborgeräte - Teil 2-040: Besondere
particulières pour stérilisateurs et laveurs désinfecteurs Anforderungen an Sterilisatoren und Reinigungs-
utilisés pour traiter le matériel médical Desinfektionsgeräte für die Behandlung medizinischen
(IEC 61010-2-040:2015) Materials
(IEC 61010-2-040:2015)
This European Standard was approved by CENELEC on 2015-08-11. 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, 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: Avenue Marnix 17, B-1000 Brussels
© 2015 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN 61010-2-040:2015 E

European foreword
The text of document 66/570/FDIS, future edition 2 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 61010-2-040:2015.
The following dates are fixed:
(dop) 2016-05-11
• latest date by which the document has to be implemented at
national level by publication of an identical national
standard or by endorsement
(dow) 2018-08-11
• latest date by which the national standards conflicting with
the document have to be withdrawn

This document supersedes EN 61010-2-040:2005.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC [and/or CEN] shall not be held responsible for identifying any or all such
patent rights.
Endorsement notice
The text of the International Standard IEC 61010-2-040:2015 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 60079 NOTE Harmonized in EN 60079 series.
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 NOTE Harmonized as EN 60601-1.
IEC 60825-1 NOTE Harmonized as EN 60825-1.
IEC 61010-2-010 NOTE Harmonized as EN 61010-2-010.
IEC 61058 NOTE Harmonized in EN 61058 series.
IEC 61672-1 NOTE Harmonized as EN 61672-1.
IEC 61672-2 NOTE Harmonized as EN 61672-2.
IEC 62061 NOTE Harmonized as EN 62061.
IEC 62304 NOTE Harmonized as EN 62304.
ISO 10472 NOTE Harmonized in EN ISO 10472 series.
ISO 12100:2010 NOTE Harmonized as EN ISO 12100:2010.
ISO 13849-2 NOTE Harmonized as EN ISO 13849-2.
ISO 14971 NOTE Harmonized as EN ISO 14971.

Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
NOTE 1 When 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.

Publication Year Title EN/HD Year
Addition to Annex ZA of EN 61010-1:2010:
IEC 61770 -  Electric appliances connected to the water EN 61770 -
mains - Avoidance of backsiphonage and
failure of hose-sets
IEC 62471 -  Photobiological safety of lamps and lamp EN 62471 -
systems
IEC/TR 62471-2 -  Photobiological safety of lamps and lamp - -
systems -
Part 2: Guidance on manufacturing
requirements relating to non-laser optical
radiation safety
ISO 3585 -  Borosilicate glass 3.3 - Properties - -
ISO 4126-1 -  Safety devices for protection against EN ISO 4126-1 -
excessive pressure -
Part 1: Safety valves
ISO 4126-2 -  Safety devices for protection against EN ISO 4126-2 -
excessive pressure -
Part 2: Bursting disc safety devices

IEC 61010-2-040 ®
Edition 2.0 2015-07
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
GROUP SAFETY PUBLICATION
PUBLICATION GROUPÉE DE SÉCURITÉ

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

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 19.080; 71.040.10 ISBN 978-2-8322-2776-3

– 2 – IEC 61010-2-040:2015 © IEC 2015
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 . 14
8 Mechanical resistance to shock and impact . 19
9 Protection against the spread of fire . 19
10 Equipment temperature limits and resistance to heat . 19
11 Protection against HAZARDS from fluids . 20
12 Protection against radiation, including laser sources, and against sonic and
ultrasonic pressure . 23
13 Protection against liberated gases, substances, explosion and implosion . 25
14 Components . 31
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

Table 101 – Lamp or lamp systems considered photobiologically safe . 24
Table 102 – Lamp or lamp systems considered photobiologically safe under certain
conditions . 24

IEC 61010-2-040:2015 © IEC 2015 – 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-
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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
ass
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