EN 80601-2-58-2015 en Medical electrical equipment - Part 2-58 Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices.pdf

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1、BSI Standards PublicationMedical electrical equipmentPart 2-58: Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgeryBS EN 80601-2-58:2015National forewordThis British Standard is the UK implementation of EN 80601

2、-2-58:2015. It isidentical to IEC 80601-2-58:2014. It supersedes BS EN 80601-2-58:2009+A11:2011, which will be withdrawn on 29 May 2018.The UK participation in its preparation was entrusted by TechnicalCommittee CH/62, Electrical Equipment in Medical Practice, toSubcommittee CH/62/4, Electromedical

3、equipment.A list 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 2015.Published by BS

4、I Standards Limited 2015ISBN 978 0 580 80697 1ICS 11.040.70Compliance 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 June 2015.Amendments/corrigenda issued since publicat

5、ionDate Text affectedBRITISH STANDARDBS EN 80601-2-58:2015EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN 80601-2-58 May 2015 ICS 11.040.70 Supersedes EN 80601-2-58:2009 English Version Medical electrical equipment - Part 2-58: Particular requirements for the basic safety and essential performance

6、 of lens removaldevices and vitrectomy devices for ophthalmic surgery (IEC 80601-2-58:2014) Appareils lectromdicaux - Partie 2-58: Exigencesparticulires pour la scurit de base et les performancesessentielles des dispositifs de retrait du cristallin et desdispositifs de vitrectomie pour la chirurgie

7、ophtalmique (IEC 80601-2-58:2014) Medizinische elektrische Gerte - Teil 2-58: BesondereFestlegungen fr die Sicherheit einschlielich derwesentlichen Leistungsmerkmale fr Gerte zur Linsenentfernung und Gerte zur Glaskrperentfernung inder Augenchirurgie (IEC 80601-2-58:2014) This European Standard was

8、approved by CENELEC on 2014-10-09. 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

9、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 i

10、ts 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 Maced

11、onia, 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 Comit Europ

12、en de Normalisation ElectrotechniqueEuropisches 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 80601-2-58:2015 E EN 80601-2-

13、58:2015 2 Foreword The text of document 62D/1151/FDIS, future edition 2 of IEC 80601-2-58 prepared by SC 62D “Electromedical equipment“ of IEC/TC 62 “Electrical equipment in medical practice“ and SC 7 “Ophthalmic optics and instruments“ of ISO/TC 172 “Optics and photonics“ was submitted to the IEC-C

14、ENELEC parallel vote and approved by CENELEC as EN 80601-2-58:2015. 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) 2015-11-29 latest date by which the national standards

15、 conflicting with the document have to be withdrawn (dow) 2018-05-29 This document supersedes EN 80601-2-58:2009. 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

16、 or all such patent rights. This document has been prepared under a mandate given to CENELEC by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive. For the relationship with EU Directive 93/42/EEC, see informative Annex ZZ, which is a

17、n integral part of this document. Endorsement notice The text of the International Standard IEC 80601-2-58:2014 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 60

18、065:2001 NOTE Harmonized as EN 60065:2002 1)(modified). IEC 60825-1 NOTE Harmonized as EN 60825-1. IEC 60950-1 NOTE Harmonized as EN 60950-1. IEC 61847 NOTE Harmonized as EN 61847. ISO 15004-2:2007 NOTE Harmonized as EN ISO 15004-2:2007 (not modified). ISO 15752:2010 NOTE Harmonized as EN ISO 15752:

19、2010 (not modified). 1)Superseded by EN 60065:2014 (IEC 60065:2014): DOW = 2017-11-17. BS EN 80601-2-58:2015EN 80601-2-58:2015 3 Annex ZA (normative) Normative references to international publications with their corresponding European publications The following documents, in whole or in part, are no

20、rmatively 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

21、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 Annex ZA of EN 60601-1:2006 applies except as follows: Repl

22、acement: IEC 60601-1-2 (mod) 2007 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests EN 60601-1-2 + corr. March 2007 1)2010 1)Addition: IEC 60601-2-2 - Medical electric

23、al equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories EN 60601-2-2 - IEC 60601-2-22 - Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essentia

24、l performance of surgical, cosmetic, therapeutic and diagnostic laser equipment EN 60601-2-22 - ISO 11607-1 2006 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems EN ISO 11607-1 2009 ISO 11607-2 2006 Packaging for

25、terminally sterilized medical devices - Part-2: Validation requirements for forming, sealing and assembly processes EN ISO 11607-2 2006 ISO 17664 2004 Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices EN ISO 17664 2

26、004 1)Superseded by EN 60601-1-2:2014 (IEC 60601-1-2:2014): DOW = 2018-12-31. BS EN 80601-2-58:2015EN 80601-2-58:2015 4 Annex ZZ (informative) Coverage of Essential Requirements of EU Directives This European Standard has been prepared under a mandate given to CENELEC by the European Commission and

27、the European Free Trade Association, and within its scope the Standard covers all relevant essential requirements given in Annex I of EU Directive 93/42/EEC of 14 June 1993 concerning medical devices. Compliance with this standard provides one means of conformity with the specified essential require

28、ments of the Directive concerned. WARNING: Other requirements and other EU Directives can be applied to the products falling within the scope of this standard. BS EN 80601-2-58:2015 2 IEC 80601-2-58:2014 IEC 2014 CONTENTS FOREWORD . 3 INTRODUCTION . 5 201.1 Scope, object and related standards . 6 20

29、1.2 Normative references 7 201.3 Terms and definitions 8 201.4 General requirements 10 201.5 General requirements for testing of ME EQUIPMENT . 10 201.6 Classification of ME EQUIPMENT and ME SYSTEMS 11 201.7 ME EQUIPMENT identification, marking and documents 11 201.8 Protection against electrical HA

30、ZARDS from ME EQUIPMENT 12 201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 12 201.10 Protection against unwanted and excessive radiation HAZARDS 12 201.11 Protection against excessive temperatures and other HAZARDS 12 201.12 Accuracy of controls and instruments and prote

31、ction against hazardous outputs 13 201.13 Hazardous situations and fault conditions for ME EQUIPMENT 21 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 21 201.15 Construction of ME EQUIPMENT . 21 201.16 * ME SYSTEMS 21 201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS 22 20

32、2 Electromagnetic compatibility Requirements and tests . 22 Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT and ME SYSTEMS 23 Annex AA (informative) Particular guidance and rationale 24 Bibliography 26 Index of defined terms 27 Figure 201.101 Test method for gravit

33、y fed IRRIGATION . 14 Figure 201.102 Test method for pressurized IRRIGATION . 15 Figure 201.103 Test method for ASPIRATION pressure measurement/display accuracy 16 Figure 201.104 Test method for ultrasonic velocity of tip accuracy . 18 Table 201.101 Key of symbols for Figure 201.101 to Figure 201.10

34、3 . 16 Table 201.C.101 ACCOMPANYING DOCUMENTS, instructions for use of LENS REMOVAL DEVICES and VITRECTOMY DEVICES or their parts . 23 BS EN 80601-2-58:2015IEC 80601-2-58:2014 IEC 2014 3 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ MEDICAL ELECTRICAL EQUIPMENT Part 2-58: Particular requirements for t

35、he basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery FOREWORD 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising all national electrotechnical committees (IEC National Committees

36、). 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 S

37、pecifications (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 organizat

38、ions 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 matte

39、rs 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

40、 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

41、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

42、does not provide 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

43、 have the latest 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 wh

44、atsoever, whether 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 publ

45、ications is indispensable 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 st

46、andard IEC 80601-2-58 has been prepared by subcommittee 62D: Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical practice, and subcommittee SC 7: Ophthalmic optics and instruments of ISO technical committee 172: Optics and photonics. This second edition cancels a

47、nd replaces the first edition of IEC 80601-2-58 published in 2008. It is published as a double logo standard. BS EN 80601-2-58:2015 4 IEC 80601-2-58:2014 IEC 2014 The text of this standard is based on the following documents: FDIS Report on voting 62D/1151/FDIS 62D/1161/RVD Full information on the v

48、oting for the approval of this standard can be found in the report on voting indicated in the above table. In ISO, the standard has been approved by 12 P members out of 12 having cast a vote. This publication has been drafted in accordance with the ISO/IEC Directives, Part 2. In this standard, the f

49、ollowing print types are used: Requirements and definitions: roman type. Test specifications: italic type. Informative material appearing outside of tables, such as notes, examples and references: in smaller type. Normative text of tables is also in a smaller type. TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS NOTED: SMALL CAPITALS. In referring to the structure of this standard, the term “clause” means one of the seventeen numbered divisions within the table