EN 60601-2-63-2015 en Medical electrical equipment - Part 2-63 Particular requirements for the basic safety and essential performance of dental extraoral X-ray equipment.pdf

1、BSI Standards PublicationMedical electrical equipmentPart 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipmentBS EN 60601-2-63:2015National forewordThis British Standard is the UK implementation of EN 60601-2-63:2015. It isidentical to IEC

2、 60601-2-63:2012.The UK participation in its preparation was entrusted by TechnicalCommittee CH/62, Electrical Equipment in Medical Practice, toSubcommittee CH/62/2, Diagnostic imaging equipment.A list of organizations represented on this committee can be obtained onrequest to its secretary.This pub

3、lication 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 BSI Standards Limited 2015ISBN 978 0 580 67031 2ICS 11.040.50Compliance with a British Standard cannot confer immunit

4、y fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 30 June 2015.Amendments/corrigenda issued since publicationDate Text affectedBRITISH STANDARDBS EN 60601-2-63:2015EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 6060

5、1-2-63 May 2015 ICS 11.040.50 English Version Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment (IEC 60601-2-63:2012) Appareils lectromdicaux - Partie 2-63: Exigences particulires pour la scurit de ba

6、se et les performances essentielles des appareils rayonnement X dentaires extra-oraux (IEC 60601-2-63:2012) Medizinische elektrische Gerte - Teil 2-63: Besondere Festlegungen fr die Sicherheit einschlielich der w esentlichen Leistungsmerkmale von extraoralen zahnrztlichen Rntgeneinrichtungen (IEC 60

7、601-2-63:2012) This European Standard w as approved by CENELEC on 2012-10-24. CENELEC members are bound to comply w ith the CEN/CENELEC Internal Regulations w hich stipulate the conditions for giving this European Standard the status of a national standard w ithout any alteration. Up-to-date lists a

8、nd bibliographical references concerning such national standards may be obtained on application to the CEN-CENEL EC 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 unde

9、r the responsibility of a CENELEC member into its ow n 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, Es

10、tonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norw ay, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sw eden, Switzerland, Turkey and the United Kingdom. European Commit

11、tee for Electrotechnical Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung CEN-CENEL EC Management Centre: Avenue Marnix 17, B-1000 Brussels 2015 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENE

12、LEC Members. Ref . No. EN 60601-2-63:2015 E BS EN 60601-2-63:2015EN 60601-2-63:2015 2 Foreword The text of document 62B/888/FDIS, future edition 1 of IEC 60601-2-63, prepared by SC 62B “Diagnostic imaging equipment“ of IEC/TC 62 “Electrical equipment in medical practice“ was submitted to the IEC-CEN

13、ELEC parallel vote and approved by CENELEC as EN 60601-2-63:2015. 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 c

14、onflicting with the document have to be withdrawn (dow) 2018-05-29 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. This document has b

15、een 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 an integral part of this document. Endorsement n

16、otice The text of the International Standard IEC 60601-2-63:2012 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 60601-2-7:1998 NOTE Harmonised as EN 60601-2-7:19

17、98 1)(not modified). IEC 60601-2-28:2010 NOTE Harmonised as EN 60601-2-28:2010 (not modified). IEC 60601-2-32:1994 NOTE Harmonised as EN 60601-2-32:1994 1)(not modified). IEC 60601-2-43:2010 NOTE Harmonised as EN 60601-2-43:2010 (not modified). IEC 60601-2-44:2009 NOTE Harmonised as EN 60601-2-44:20

18、09 (not modified). IEC 60601-2-45:2011 NOTE Harmonised as EN 60601-2-45:2011 (not modified). IEC 60601-2-65:2012 NOTE Harmonised as EN 60601-2-65:2013 (not modified). 1)Superseded by EN 60601-2-54:2009 (IEC 60601-2-54:2009) and partially by EN 60601-2-65:2013 (IEC 60601-2-65:2012). BS EN 60601-2-63:

19、2015EN 60601-2-63:2015 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, o

20、nly 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 by common modifications, indicated by (mod), the relevant EN/HD applies. NOTE 2 Up-to-date information o

21、n 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: Replacement: IEC 60601-1-2 (mod) 2007 Medical electrical equipment - Part 1-2: General requirements for basi

22、c safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests EN 60601-1-2 + corr. March 2007 1)2010 1)IEC 60601-1-3 2008 Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard:

23、 Radiation protection in diagnostic X-ray equipment EN 60601-1-3 + corr. March 2008 2010 Addition: IEC 60336 - Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Characteristics of focal spots EN 60336 - IEC 60601-2-29 2008 Medical electrical equipment - Part 2-29: Particul

24、ar requirements for the basic safety and essential performance of radiotherapy simulators EN 60601-2-29 + A11 2008 2011 IEC 60601-2-54 2009 Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radiosco

25、py EN 60601-2-54 2009 IEC/TR 60788 2004 Medical electrical equipment - Glossary of defined terms - - IEC/PAS 61910-1 2007 Medical electrical equipment - Radiation dose documentation - Part 1: Equipment for radiography and radioscopy - - 1)Superseded by EN 60601-1-2:2014 (IEC 60601-1-2:2014): DOW = 2

26、018-12-31. BS EN 60601-2-63:2015EN 60601-2-63:2015 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 the European Free Trade Association, and within its scope the Stand

27、ard 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 requirements of the Directive concerned. WARNING: Other requirements and o

28、ther EU Directives can be applied to the products falling within the scope of this standard. BS EN 60601-2-63:2015 2 60601-2-63 IEC:2012 CONTENTS FOREWORD . 4 INTRODUCTION . 7 201.1 Scope, object and related standards . 8 201.2 Normative references 10 201.3 Terms and definitions 11 201.4 General req

29、uirements 12 201.5 General requirements for testing of ME EQUIPMENT . 13 201.6 Classification of ME EQUIPMENT and ME SYSTEMS 13 201.7 ME EQUIPMENT identification, marking and documents 13 201.8 Protection against electrical HAZARDS from ME EQUIPMENT 16 201.9 Protection against MECHANICAL HAZARDS of

30、ME EQUIPMENT and ME SYSTEMS 17 201.10 Protection against unwanted and excessive radiation HAZARDS 18 201.11 Protection against excessive temperatures and other HAZARDS 18 201.12 Accuracy of controls and instruments and protection against hazardous outputs 18 201.13 HAZARDOUS SITUATIONS and fault con

31、ditions . 18 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 18 201.15 Construction of ME EQUIPMENT . 18 201.16 ME SYSTEMS 18 201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 19 202 Electromagnetic compatibility Requirements and tests . 19 203 Radiation protection in dia

32、gnostic X-ray equipment . 19 Annexes . 31 Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT and ME SYSTEMS 32 Annex AA (informative) Particular guidance and rationale 33 Bibliography 39 Index of defined terms used in this particular standard 42 Figure 203.101 Zone of

33、 EXTRA-FOCAL RADIATION . 28 Figure AA.1 PANORAMIC X-RAY EQUIPMENT . 33 Figure AA.2 AIR KERMA during IRRADIATION with direct current X-RAY GENERATOR . 35 Figure AA.3 AIR KERMA during IRRADIATION with ONE-PEAK X-RAY GENERATOR . 36 Figure AA.4 Example series of (numerous) pulsed IRRADIATIONS for a CBCT

34、 (cone beam computed tomography) IRRADIATION event, with CONSTANT POTENTIAL HIGH-VOLTAGE GENERATOR and time-width modulation 37 Figure AA.5 Example series of two irradiations for PANORAMIC-like views of right and left TMJ (temporo-mandibolar joint) in the same image, with ONE-PEAK HIGH-VOLTAGE GENER

35、ATOR 37 BS EN 60601-2-63:201560601-2-63 IEC:2012 3 Table 201.101 List of potential ESSENTIAL PERFORMANCE to be considered by MANUFACTURER in the RISK MANAGEMENT PROCESS 13 Table 201.C.101 Marking on the outside of ME EQUIPMENT or its parts 32 Table 201.C.102 Subclauses requiring statements in ACCOMP

36、ANYING DOCUMENTS . 32 BS EN 60601-2-63:2015 4 60601-2-63 IEC:2012 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ MEDICAL ELECTRICAL EQUIPMENT Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment FOREWORD 1) The International Electrotechn

37、ical 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

38、 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 C

39、ommittee 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

40、 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 a

41、ll 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

42、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 dive

43、rgence between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in the latter. 5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity assessment services and, in some areas, access to IEC

44、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 latest edition of this publication. 7) No liability shall attach to IEC or its directors, employees, servants or agents including individual exp

45、erts and members of its technical committees and IEC National Committees for any personal injury, property damage or other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and expenses arising out of the publication, use of, or reliance upon, this IEC

46、Publication or any other IEC Publications. 8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is indispensable for the correct application of this publication. 9) Attention is drawn to the possibility that some of the elements of this IEC

47、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 60601-2-63 has been prepared by IEC subcommittee 62B: Diagnostic imaging equipment, of IEC technical committee 62: Electrical equipment in medi

48、cal practice. The text of this particular standard is based on the following documents: FDIS Report on voting 62B/888/FDIS 62B/898/RVD Full information on the voting for the approval of this particular standard can be found in the report on voting indicated in the above table. This publication has b

49、een drafted in accordance with the ISO/IEC Directives, Part 2. In this standard, the following print types are used: BS EN 60601-2-63:201560601-2-63 IEC:2012 5 Requirements and definitions: in roman type. Test specifications: in 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