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EN 61010-2-040:2015

(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 61010-2-040:2015 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. It has the status of a group safety publication, as specified in IEC Guide 104. This second edition cancels and replaces the first edition published in 2005. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) A new clause (4.3.2.101) has been added for non-electrical supplies and services. b) Additional requirements for marking and documentation (Clause 5) have been added. c) Additional requirements for protection against mechanical hazards (Clause 7) have been included. d) Additional requirements for protection against radiation, including laser sources, and against sonic and ultrasonic pressure (Clause 12) have been included.

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

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
Published
Publication Date
10-Sep-2015
Withdrawal Date
10-Aug-2018
ICS
19.080 - Electrical and electronic testing
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
Current Stage
6060 - Document made available - Publishing
Start Date
11-Sep-2015
Completion Date
11-Sep-2015
Ref Project
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)

Relations

Replaces
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
Effective Date
15-Sep-2015
Replaced By
EN IEC 61010-2-040:2021 - 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
07-Jun-2022

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 61010-2-040:2016
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
SIST EN 61010-2-040:2016 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

SIST EN 61010-2-040:2016

---------------------- Page: 2 ----------------------

SIST EN 61010-2-040:2016


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

---------------------- Page: 3 ----------------------

SIST EN 61010-2-040:2016
EN 61010-2-040:2015
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 ident
...

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This clause of Part 1 is applicable except as follows: 1.1.1 Equipment included in scope Replacement: Replace the text, except the first paragraph, by the following new text: This part of IEC 61010 applies to automatic and semi-automatic laboratory equipment for analysis and other purposes. Automatic and semi-automatic laboratory equipment consists of instruments or systems for measuring or modifying one or more characteristics or parameters of samples, performing the complete process or parts of the process without manual intervention. Equipment forming part of such a system is within the scope of this document. Examples of equipment within the scope of this document include: - analytical equipment; - automatic sampler (pipettor, aliquoter); - equipment for sample replication and amplification. NOTE 1 In the case of analytical equipment, the complete process usually includes the following steps: - taking a specific quantity of the sample; - preparing the sample by chemical, thermal, mechanical or other means; - measurement; - display, transmission or printing of the results of measurement. NOTE 2 If all or part of the equipment falls within the scope of one or more other Part 2 documents of IEC 61010 as well as within the scope of this document, consideration is given to those other Part 2 documents. 1.1.2 Equipment excluded from scope Addition: Add the following new item: aa) IEC 61010-2-101 (in vitro diagnostic (IVD) equipment). 1.2 Object 1.2.1 Aspects included in scope Addition: Add the following new items: aa) biohazards; bb) hazardous chemical substances. 1.2.2 Aspects excluded from scope Addition: Add the following new item and note: aa) handling or manipulation of material outside the equipment. NOTE Requirements covering these subjects are the responsibility of committees preparing the relevant standards.

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