1、Safety requirements for electrical equipment for measurement, control and laboratory usePart 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipmentBS EN 61010-2-101:2017BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06National forewordThis Brit
2、ish Standard is the UK implementation of EN 61010-2-101:2017. Itis identical to IEC 61010-2-101:2015. It supersedes BS EN 61010-2-101:2002which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee EPL/66, Safety of measuring, control and laboratory equipment.A lis
3、t of organizations represented on this committee can be obtained onrequest to its secretary.This publication does not purport to include all the necessary provisions ofa contract. Users are responsible for its correct application. The British Standards Institution 2017.Published by BSI Standards Lim
4、ited 2017ISBN 978 0 580 80361 1ICS 71.040.10; 11.040.55; 19.080Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 31 March 2017.Amendments/corrigenda issued since pub
5、licationDate Text affectedBRITISH STANDARDBS EN 61010-2-101:2017EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 61010-2-101 February 2017 ICS 11.040.55; 19.080 Supersedes EN 61010-2-101:2002 English Version Safety requirements for electrical equipment for measurement, control and laboratory use
6、 - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment (IEC 61010-2-101:2015) Rgles de scurit pour appareils lectriques de mesurage, de rgulation et de laboratoire - Partie 2-101: Exigences particulires pour les appareils mdicaux de diagnostic in vitro (DIV) (IEC 6101
7、0-2-101:2015) Sicherheitsbestimmungen fr elektrische Mess-, Steuer-, Regel- und Laborgerte - Teil 2-101: Besondere Anforderungen an In-vitro-Diagnostik (IVD)-Medizingerte (IEC 61010-2-101:2015) This European Standard was approved by CENELEC on 2015-02-27. CENELEC members are bound to comply with the
8、 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
9、 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
10、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, Lithu
11、ania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. European Committee for Electrotechnical Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrote
12、chnische Normung CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2017 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members. Ref. No. EN 61010-2-101:2017 E BS EN 61010-2-101:2017EN 61010-2-101:2017 2 European foreword The text of docu
13、ment 66/545/FDIS, future edition 2 of IEC 61010-2-101, 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 61010-2-101:2017. The following dates are fixed: latest date by which the document has to
14、be implemented at national level by publication of an identical national standard or by endorsement (dop) 2017-08-24 latest date by which the national standards conflicting with the document have to be withdrawn (dow) 2020-02-24 This document supersedes EN 61010-2-101:2002. Attention is drawn to the
15、 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. This document has been prepared under a mandate given to CENELEC by the European Commission and the European Fr
16、ee Trade Association, and supports essential requirements of EU Directive(s). For the relationship with EU Directive(s) see informative Annex ZZ, which is an integral part of this document. Endorsement notice The text of the International Standard IEC 61010-2-101:2015 was approved by CENELEC as a Eu
17、ropean Standard without any modification. The Bibliography of EN 61010-1:2010 is applicable except as follows: In the bibliography of EN 61010-1:2010, the following note has to be added for the standard indicated: ISO 15223-1 NOTE Harmonized as EN ISO 15223-1. BS EN 61010-2-101:2017EN 61010-2-101:20
18、17 3 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 cite
19、d 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 version
20、s of the European Standards listed in this annex is available here: www.cenelec.eu. Annex ZA of EN 61010-1:2010 is applicable, except as follows: Publication Year Title EN/HD Year Addition: ISO 13857 - Safety of machinery - Safety distances to prevent hazard zones being reached by upper and lower li
21、mbs EN ISO 13857 - ISO 14971 - Medical devices - Application of risk management to medical devices EN ISO 14971 - ISO 18113-5 - In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing EN ISO 18113-5 - BS EN
22、 61010-2-101:2017EN 61010-2-101:2017 4 Annex ZZ (informative) Relationship between this European Standard and the essential requirements of Directive 98/79/EC OJ L 331 aimed to be covered This European Standard has been prepared under a Commissions standardisation request, M/252, concerning the deve
23、lopment of European Standards relating to in vitro diagnostic medical devices, to provide one voluntary means of conforming to essential requirements of Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices OJ L 331. Once this stan
24、dard 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 essential requirements of that Dir
25、ective, and associated EFTA regulations. NOTE 1 This standard is intended to be applied in its entirety only. Selected clauses or subclauses may be not applicable due to the specific type of equipment under consideration. It is necessary to understand and apply Clauses 1 to 4. It is also recommended
26、 to understand and apply those clauses which contain general requirements related to a specific subclause. Elements of the standard that are not cited in Table ZZ.1 may be relevant for the appropriate fulfilment of certain essential requirements through indirect reference, and for safety and perform
27、ance aspects of the device, that are not addressed through essential requirements. NOTE 2 Where a reference from a clause of this standard to the risk management process is made, the risk management process needs to be in compliance with Directive 98/79/EC. This means that risks have to be reduced a
28、s far as possible, to a minimum, to the lowest possible level, minimized or removed, according to the wording of the corresponding essential requirement. NOTE 3 The manufacturers policy for determining acceptable risk must be in compliance with Essential Requirements Part A: 1, 2 and 5; Part B: 1.2,
29、 2, 3, 5, 6 and 7 of the Directive. NOTE 4 This Annex ZZ is based on normative references according to Annex ZA, replacing the references in the core text. NOTE 5 When an Essential Requirement does not appear in Table ZZ.1, it means that it is not addressed by this European Standard. BS EN 61010-2-1
30、01:2017EN 61010-2-101:2017 5 Table ZZ.1 Correspondence between this European Standard and Annex I of Directive 98/79/EC OJ L 331 Essential Requirements of Directive 98/79/EC Clause(s) / sub-clause(s) of this EN Remarks / Notes A GENERAL REQUIREMENTS 1 Clauses 6 to 13, Clause 17 Fully covered for the
31、 hazards identified in Clauses 6 to 13. Clause 17 covers hazards and risks not addressed by the clauses above. See especially Note 2 above. 2 Clauses 6 to 16, Clause 17 Covered. Clause 17 by applying EN ISO 14971. B DESIGN AND MANUFACTURING REQUIREMENTS 1.2 5.4.102, 8.101, Clause 13 Partially covere
32、d. Special design considerations for transport and storage are not addressed. 2.1 7.3.1, 7.3.3, 7.3.101, Clause 11, 13.101 and Clause 17 Partially covered. This safety standard does not address the risks in device manufacturing processes. 3.1 5.4.6, 6.6.1, 6.6.2 Partially covered with respect to the
33、 effects of the device being assessed to the safety of a combination. This safety standard does not address performance of a device. 3.2 Clause 11, Clause 13 Covered. 3.3 indent one 7.4, 7.5, 11.7, 16.2 Covered. 3.3 indent two Clause 8, 10.5, 11.3, 11.6 Partially covered with respect to mechanical a
34、nd temperature effects and penetration of substances. 3.4 Clause 9 and 13.2 Covered. 3.5 5.4.101 Covered. 3.6 16.2 Partially covered with respect to hazards. 5.1 Clause 12 Covered. 5.3 5.4.3 j) Partially covered with respect to protective measures. 6.3 Clause 6 Covered. 6.4.1 Clause 7, Clause 13 and
35、 Clause 15 Partially covered. Third paragraph requirements are not specifically addressed. 6.4.3 12.5 Covered. 6.4.4 5.1.5, 6.10, 6.11 and 13.101 Covered. 6.4.5 10.1 Covered. 8.1 Clause 5 Partially covered with respect to safe use of the device. BS EN 61010-2-101:2017EN 61010-2-101:2017 6 Essential
36、Requirements of Directive 98/79/EC Clause(s) / sub-clause(s) of this EN Remarks / Notes 8.2 5.1.1 Covered. 8.4 (a) 5.1.2 a) Partially covered. This standard does not address the specifics of imported devices (authorized representative). 8.4 (b) 5.1.2 b) Partially covered. Limited to details related
37、to the identification of the device. 8.4 (d) 5.1.2 1) Covered. 8.4 (g) 5.1.2 2) i) Covered. 8.4 (h) 5.1.101 Partially covered. Particular conditions for handling are not addressed. 8.4 (j) 5.2 Covered. 8.4 (k) 5.1.2 2) ii) Covered. 8.5 5.4.1 Partially covered. Requirements for the label are not addr
38、essed. 8.6 5.1.2 1), 5.1.2 2) iii) Covered. 8.7 (a) Referring to: 8.4 (a) 8.4 (h) 8.4 (i) 8.4 (j) 5.4.1 c) 5.4.102, 5.4.4 i) 5.4.4 5.4.3, 5.4.4 Partially covered. This standard does not address the specifics of imported devices (authorized representative). Covered. Covered. Covered. 8.7 (s) 5.4.101
39、and 13.101 Covered 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 Journ
40、al of the European Union. WARNING 2 Other Union legislation may be applicable to the product(s) falling within the scope of this standard. BS EN 61010-2-101:2017 2 IEC 61010-2-101:2015 IEC 2015 CONTENTS FOREWORD . 3 1 Scope and object . 6 2 Normative references. 7 3 Terms and definitions 7 4 Tests .
41、 7 5 Marking and documentation . 8 6 Protection against electric shock 12 7 Protection against mechanical HAZARDS 12 8 Resistance to mechanical stresses . 14 9 Protection against the spread of fire . 14 10 Equipment temperature limits and resistance to heat 14 11 Protection against HAZARDS from flui
42、ds . 14 12 Protection against radiation, including laser sources, and against sonic and ultrasonic pressure 14 13 Protection against liberated gases and substances, explosion and implosion 15 14 Components and subassemblies 15 15 Protection by interlocks 15 16 HAZARDS resulting from application. 15
43、17 RISK assessment . 16 Annexes . 16 Annex L (informative) Index of defined terms 17 Bibliography . 18 Table 1 Symbols 8 BS EN 61010-2-101:2017IEC 61010-2-101:2015 IEC 2015 3 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL AND LABORAT
44、ORY USE Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment 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
45、 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)
46、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 t
47、he 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 nearl
48、y 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
49、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 r
