1、BSI Standards PublicationSafety requirements for electrical equipment for measurement, control, and laboratory usePart 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical materialsBS EN 61010-2-040:2015National forewordThis British Standard is the UK implemen
2、tation of EN 61010-2-040:2015. It is identical to IEC 61010-2-040:2015. It supersedes BS EN 61010-2-040:2005,which will be withdrawn on 11 August 2018.The UK participation in its preparation was entrusted to TechnicalCommittee EPL/66, Safety of measuring, control and laboratory equipment.A list of o
3、rganizations represented on this committee can be obtained onrequest to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2015.Published by BSI Standards Limited
4、2015ISBN 978 0 580 78856 7ICS 11.080.10; 19.080; 71.040.10Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 30 September 2015.Amendments/corrigenda issued since publ
5、icationDate Text affectedBRITISH STANDARDBS EN 61010-2-040:2015EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 61010-2-040 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 us
6、e - Part 2-040 Particular requirements for sterilizers and washer-disinfectors used to treat medical materials (IEC 61010-2-040:2015) Rgles de scurit pour appareils lectriques de mesurage, de rgulation et de laboratoire - Partie 2-040: Exigences particulires pour strilisateurs et laveurs dsinfecteur
7、s utiliss pour traiter le matriel mdical (IEC 61010-2-040:2015) Sicherheitsbestimmungen fr elektrische Mess-, Steuer-, Regel- und Laborgerte - Teil 2-040: Besondere Anforderungen an Sterilisatoren und Reinigungs-Desinfektionsgerte fr die Behandlung medizinischen Materials (IEC 61010-2-040:2015) This
8、 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 refe
9、rences 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
10、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 Yu
11、goslav 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 St
12、andardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr 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 610
13、10-2-040:2015 E BS EN 61010-2-040:2015EN 61010-2-040:2015 2 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
14、 EN 61010-2-040:2015. The following dates are fixed: latest date by which the document has to be implemented at national level by publication of an identical national standard or by endorsement (dop) 2016-05-11 latest date by which the national standards conflicting with the document have to be with
15、drawn (dow) 2018-08-11 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 notic
16、e 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-
17、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
18、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. BS EN 61010-2-040:2015EN 61010-2-040:2015 3 IEC 61672-2 NOTE Harmonized as EN 61672-2. IEC 62061 NOTE Harmonized as EN 62061. IEC 62304 NOTE Harm
19、onized 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. BS EN 61010-2-040:2015EN 61010-2-040:2015 4 Annex ZA (normative) Normative references t
20、o 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 ed
21、ition 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
22、 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 mains - Avoidance of backsiphonage and failure of hose-sets EN 61770 - IEC 62471 - Photobiological safety of lamps and lamp systems EN
23、 62471 - 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 excessive pressure - Pa
24、rt 1: Safety valves EN ISO 4126-1 - ISO 4126-2 - Safety devices for protection against excessive pressure - Part 2: Bursting disc safety devices EN ISO 4126-2 - BS EN 61010-2-040:2015 2 IEC 61010-2-040:2015 IEC 2015 CONTENTS FOREWORD . 3 1 Scope and object . 5 2 Normative references 6 3 Terms and de
25、finitions 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 t
26、emperature 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 Protecti
27、on 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
28、safe 24 Table 102 Lamp or lamp systems considered photobiologically safe under certain conditions . 24 BS EN 61010-2-040:2015IEC 61010-2-040:2015 IEC 2015 3 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL, AND LABORATORY USE Part 2-04
29、0: 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
30、 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
31、 (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
32、 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, a
33、s 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 i
34、n 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 Comm
35、ittees 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 prov
36、ide 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 lat
37、est 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, whe
38、ther 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 i
39、ndispensable 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 61
40、010-2-040 has been prepared by IEC technical committee 66: Safety of measuring, control and laboratory equipment. 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 t
41、echnical 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. BS EN 6
42、1010-2-040:2015 4 IEC 61010-2-040:2015 IEC 2015 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 in
43、cluded. The text of this standard is based on the following documents: FDIS Report on voting 66/570/FDIS 66/576/RVD Full information on the voting for the approval of this standard can be found in the report on voting indicated in the above table. This publication has been drafted in accordance with
44、 the ISO/IEC Directives, Part 2. 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 intended to be used in conjunction with IEC 6
45、1010-1. It was established on the basis of the third edition (2010). Consideration may be given to future editions of, or amendments to, IEC 61010-1. 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 states “ad
46、dition”, “modification”, “replacement”, or “deletion”, the relevant requirement, test specification or note in Part 1 should 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;
47、 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).
48、 The committee has decided that the contents of this publication will remain unchanged until the stability date indicated on the IEC website under “http:/webstore.iec.ch“ in the data related to the specific publication. At this date, the publication will be reconfirmed, withdrawn, replaced by a revi
49、sed edition, or amended. BS EN 61010-2-040:2015IEC 61010-2-040:2015 IEC 2015 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 re
