EN 61010-2-040:2005

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

This International Standard 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. This document consolidates the requirements of four standards, EN 61010-2-041, EN 61010-2-042, EN 61010-2-043 and EN 61010-2-045, which are withdrawn, and aligns them with the second edition (2001) of EN 61010-1:Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements. It has the status of a group safety publication in accordance with IEC Guide 104.

Sicherheitsbestimmungen für elektrische Mess-, Steuer-, Regel- und Laborgeräte - Teil 2-040: Besondere Anforderungen an Sterilisatoren und Reinigungs-Desinfektionsgeräte für die Behandlung medizinischen 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

La présente Norme Internationale définit les règles de sécurité pour 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 environnementales de 1.4. Le présent document consolide les exigences de quatre normes, la EN 61010-2-041, la EN 61010-2-042, la EN 61010-2-043 et la EN 61010-2-045, qui sont retirées, et les aligne avec la deuxième édition de la EN 61010-1: Règles de sécurité pour appareils électriques de mesurage, de régulation et de laboratoire - Partie 1: Prescriptions générales. Cette norme a le statut de publication groupée de sécurité, conformément au Guide 104 de la CEI. OP

Varnostne zahteve za električno opremo za merjenje, nadzor in laboratorijsko uporabo - 2-040. del: Posebne zahteve za sterilizatorje in dezinfektorje pralnikov, ki se uporabljajo za obdelavo medicinskih materialov (IEC 61010-2-040:2005)

General Information

• Status: Withdrawn
• Publication Date: 07-Jul-2005
• Withdrawal Date: 31-May-2008
• ICS: 19.080 - Electrical and electronic testing
• ICS: 71.040.10 - Chemical laboratories. Laboratory equipment
• Technical Committee: CLC/TC 66X - Safety of measuring, control, and laboratory equipment
• Drafting Committee: IEC/TC 66 - IEC_TC_66
• Parallel Committee: IEC/TC 66 - IEC_TC_66
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 11-Aug-2018
• Completion Date: 11-Aug-2018
• Directive: 2006/95/EC - Directive 2006/95/EC of the European Parliament and of the Council of 12 December 2006 on the harmonisation of the laws of Member States relating to electrical equipment designed for use within certain voltage limits (codified version)
• Directive: 2014/35/EU - Directive 2014/35/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation 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
• Directive: 73/23/EEC - Electrical equipment designed for use within certain voltage limits
• Ref Project: SIST EN 61010-2-040:2006 - 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

• Replaces: EN 61010-2-043:1997 - Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-043: Particular requirements for dry heat sterilizers using either hot air or hot inert gas for the treatment of medical materials, and for laboratory processes
• Effective Date: 29-Jan-2023
• Replaces: EN 61010-2-042:1997 - Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-042: Particular requirements for autoclaves and sterilizers using toxic gas for the treatment of medical materials, and for laboratory processes
• Effective Date: 29-Jan-2023
• Replaces: EN 61010-2-045:2000 - Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-045: Particular requirements for washer disinfectors used in medical, pharmaceutical, veterinary and laboratory fields
• Effective Date: 29-Jan-2023
• Replaces: EN 61010-2-041:1996 - Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-041: Particular requirements for autoclaves using steam for the treatment of medical materials, and for laboratory processes
• Effective Date: 29-Jan-2023
• Replaced By: 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
• Effective Date: 15-Sep-2015

Standards Content (Sample)

SLOVENSKI STANDARD
01-februar-2006
1DGRPHãþD
SIST EN 61010-2-041:1999
SIST EN 61010-2-042:1999
SIST EN 61010-2-043:1999
SIST EN 61010-2-045:2002
9DUQRVWQH]DKWHYH]DHOHNWULþQRRSUHPR]DPHUMHQMHQDG]RULQODERUDWRULMVNR
XSRUDERGHO3RVHEQH]DKWHYH]DVWHULOL]DWRUMHLQGH]LQIHNWRUMHSUDOQLNRYNL
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
Sicherheitsbestimmungen für elektrische Mess-, Steuer-, Regel- und Laborgeräte -- Teil
2-040: Besondere Anforderungen an Sterilisatoren und Reinigungs-Desinfektionsgeräte
für die Behandlung medizinischen 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: EN 61010-2-040:2005
ICS:
11.080.10 Sterilizacijska oprema Sterilizing equipment
19.080 (OHNWULþQRLQHOHNWURQVNR Electrical and electronic
SUHVNXãDQMH testing
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD EN 61010-2-040
NORME EUROPÉENNE
EUROPÄISCHE NORM July 2005
ICS 19.080; 71.040.10 Supersedes EN 61010-2-041:1996 & EN 61010-2-042:1997 &
EN 61010-2-043:1997 & EN 61010-2-045:2000

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 61010-2-040:2005)
Règles de sécurité pour appareils Sicherheitsbestimmungen für elektrische
électriques de mesurage, de régulation Mess-, Steuer-, Regel- und Laborgeräte
et de laboratoire Teil 2-040: Besondere Anforderungen an
Partie 2-040: Exigences particulières Sterilisatoren und Reinigungs-
pour stérilisateurs et laveurs désinfecteurs Desinfektionsgeräte für die Behandlung
utilisés pour traiter le matériel médical medizinischen Materials
(CEI 61010-2-040:2005) (IEC 61010-2-040:2005)

This European Standard was approved by CENELEC on 2005-06-01. 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 Central Secretariat 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 Central Secretariat has the same status as the official versions.

CENELEC members are the national electrotechnical committees of Austria, Belgium, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden,
Switzerland and United Kingdom.

CENELEC
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung

Central Secretariat: rue de Stassart 35, B - 1050 Brussels

© 2005 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.

Ref. No. EN 61010-2-040:2005 E

Foreword
The text of document 66/353/FDIS, future edition 1 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 was approved by CENELEC as EN 61010-2-040 on 2005-06-01.
This European Standard supersedes EN 61010-2-041:1996 + corrigendum September 1996,
EN 61010-2-042:1997, EN 61010-2-043:1997 and EN 61010-2-045:2000.
This Part 2-040 is to be used in conjunction with EN 61010-1:2001, Safety requirements for electrical
equipment for measurement, control and laboratory use – Part 1: General requirements.
Consideration may be given to future editions of, or amendments to, EN 61010-1.
This Part 2-040 supplements or modifies the corresponding clauses of EN 61010-1:2001 so as to
convert it into the European Standard "Safety requirements for sterilizers and washer-disinfectors
used to treat medical materials".
Where a particular clause or subclause of Part 1 is not mentioned in this Part 2-040, that clause or
subclause applies as far as is reasonable. Where this part states "addition", "modification",
"replacement" or "deletion", the relevant text of Part 1 is to 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: italic type;
– terms used throughout this standard which have been defined in Clause 3: SMALL ROMAN
CAPITALS;
2) subclauses, figures, tables and notes which are additional to those in Part 1 are numbered
starting from 101.
The following dates were fixed:
– latest date by which the EN has to be implemented
at national level by publication of an identical
national standard or by endorsement (dop) 2006-03-01
– latest date by which the national standards conflicting
with the EN have to be withdrawn (dow) 2008-06-01
Annex ZA has been added by CENELEC.
__________
- 3 - EN 61010-2-040:2005
Endorsement notice
The text of the International Standard IEC 61010-2-040:2005 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 60335-2-4:2002 (not modified).
IEC 60335-2-5 NOTE Harmonized as EN 60335-2-5:2003 (modified).
IEC 60335-2-7 NOTE Harmonized as EN 60335-2-7:2003 (modified).
IEC 60335-2-11 NOTE Harmonized as EN 60335-2-11:2003 (modified).
IEC 60335-2-58 NOTE Harmonized as EN 60335-2-58:2005 (modified).
IEC 60601-1 NOTE Harmonized as EN 60601-1:1990 (not modified).
IEC 61010-2-010 NOTE Harmonized as EN 61010-2-010:2003 (not modified).
IEC 61508 NOTE Harmonized in EN 61508 series (not modified).
ISO 10472 NOTE Harmonized in EN ISO 10472 series (not modified).
__________
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
The following referenced documents are indispensable for the application 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 Where an international publication has been modified by common modifications, indicated by (mod), the relevant
EN/HD applies.
Publication Year Title EN/HD Year
IEC 60079 (mod) Series Electrical apparatus for explosive gas EN 60079 Series
atmospheres
1) 2)
IEC 61770 - Electric appliances connected to the EN 61770 1999
water mains - Avoidance of
backsiphonage and failure of hose-sets

1)
ISO 3585 - Borosilicate glass 3.3 - Properties - -

1)
ISO 6718 - Bursting discs and bursting disc devices - -

1)
Undated reference.
2)
Valid edition at date of issue.

NORME CEI
INTERNATIONALE
IEC
61010-2-040
INTERNATIONAL
Première édition
STANDARD
First edition
2005-04
PUBLICATION GROUPÉE DE SÉCURITÉ
GROUP SAFETY PUBLICATION
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
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 2005 Droits de reproduction réservés  Copyright - all rights reserved
Aucune partie de cette publication ne peut être reproduite ni No part of this publication may be reproduced or utilized in any
utilisée sous quelque forme que ce soit et par aucun procédé, form or by any means, electronic or mechanical, including
électronique ou mécanique, y compris la photocopie et les photocopying and microfilm, without permission in writing from
microfilms, sans l'accord écrit de l'éditeur. the publisher.
International Electrotechnical Commission, 3, rue de Varembé, PO Box 131, CH-1211 Geneva 20, Switzerland
Telephone: [phone] Telefax: [phone] E-mail: [e-mail] Web: www.iec.ch
CODE PRIX
V
PRICE CODE
Commission Electrotechnique Internationale
International Electrotechnical Commission
МеждународнаяЭлектротехническаяКомиссия
Pour prix, voir catalogue en vigueur
For price, see current catalogue

61010-2-040  IEC:2005 – 3 –
CONTENTS
FOREWORD.5

1 Scope and object.9
2 Normative references .11
3 Terms and definitions .11
4 Tests .13
5 Marking and documentation.15
6 Protection against electric shock .25
7 Protection against mechanical HAZARDS.27
7 Protection against mechanical HAZARDS and against HAZARDS related to
mechanical functions .27
8 Mechanical resistance to shock and impact .35
9 Protection against the spread of fire .35
10 Equipment temperature limits and resistance to heat.35
11 Protection against HAZARDS from fluids .37
12 Protection against radiation, including laser sources, and against sonic and
ultrasonic pressure .43
13 Protection against liberated gases, explosion and implosion.43
14 Components .57
15 Protection by interlocks .59
16 Test and measurement equipment.59

Annexes .61
Annex G (informative) Leakage and rupture from fluids under pressure .61
Annex H (informative) Index of defined terms.61

Bibliography.63

61010-2-040  IEC:2005 – 5 –
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
...