1、BSI Standards PublicationMedical electrical equipmentPart 2-68: Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipmentBS EN
2、60601-2-68:2015National forewordThis British Standard is the UK implementation of EN 60601-2-68:2015. It isidentical to IEC 60601-2-68:2014.The UK participation in its preparation was entrusted by TechnicalCommittee CH/62, Electrical Equipment in Medical Practice, toSubcommittee CH/62/3, Equipment f
3、or radiotherapy, nuclear medicine andradiation dosimetry.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 Bri
4、tish Standards Institution 2015.Published by BSI Standards Limited 2015ISBN 978 0 580 75388 6ICS 11.040.60Compliance 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 2
5、015.Amendments/corrigenda issued since publicationDate Text affectedBRITISH STANDARDBS EN 60601-2-68:2015EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN 60601-2-68 May 2015 ICS 11.040.60 English Version Medical electrical equipment - Part 2-68: Particular requirements for the basic safety and esse
6、ntial performance of X-ray-basedimage-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment (IEC 60601-2-68:2014) Appareils lectromdicaux - Partie 2-68: Exigencesparticulires pour la scurit de base et les performanc
7、esessentielles des appareils de radiothrapie rayonnementX assiste par imagerie mdicale, destins tre utiliss avec les acclrateurs dlectrons, les appareils de thrapie par faisceau dions lgers et les appareils de thrapie parfaisceau de radionuclides (IEC 60601-2-68:2014) Medizinische elektrische Gerte
8、- Teil 2-68: BesondereFestlegungen fr die Sicherheit einschlielich derwesentlichen Leistungsmerkmale von rntgenstrahlungsbasierten Gerten fr die bildgesteuerteStrahlentherapie zur Verwendung mitElektronenbeschleunigern, Leichtionen-Strahlentherapiesystemen und Radionuklid- Strahlentherapiesystemen (
9、IEC 60601-2-68:2014) This European Standard was 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
10、 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 und
11、er 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, Est
12、onia, 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
13、 for Electrotechnical Standardization Comit Europen 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 M
14、embers. Ref. No. EN 60601-2-68:2015 E EN 60601-2-68:2015 2 Foreword The text of document 62C/595/FDIS, future edition 1 of IEC 60601-2-68 prepared by SC 62C “Equipment for radiotherapy, nuclear medicine and radiation dosimetry“ of IEC/TC 62 “Electrical equipment in medical practice“ was submitted to
15、 the IEC-CENELEC parallel vote and approved by CENELEC as EN 60601-2-68:2015. 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
16、 standards conflicting 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 do
17、cument 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 an integral part of this document. E
18、ndorsement notice The text of the International Standard IEC 60601-2-68:2014 was approved by CENELEC as a European Standard without any modification. In the official version, for Bibliography, the following note has to be added for the standard indicated: IEC 60336:2005 NOTE Harmonized as EN 60336:2
19、005 (not modified). IEC 60364-7-710:2002 NOTE Harmonized as HD 60364-7-710:2012 (modified). IEC 60522:1999 NOTE Harmonized as EN 60522:1999 (not modified). IEC 62220-1:2003 NOTE Harmonized as EN 62220-1:2004 1)(not modified). 1)Superseded by EN 62220-1-1:2015 (IEC 62220-1-1:2015): DOW = 2018-04-16.
20、BS EN 60601-2-68:2015EN 60601-2-68:2015 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 da
21、ted 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 by common modifications, indicated by (mod), the relevant EN/HD applies. NOTE 2 Up-to-d
22、ate 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: Amendment: IEC 60601-1-3 2008 Medical electrical equipment - Part 1-3: General requirements
23、 for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment EN 60601-1-3 + corr. March 2008 2010 IEC 60601-1-6 +A1 2010 2013 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral
24、 standard: Usability EN 60601-1-6 +A1 2010 2015 Addition: IEC 60601-1 +A1 2005 2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance EN 60601-1 + corr. March + A1 + A1/AC +A12 2006 2010 2013 2014 2014 IEC 60601-2-1 2009 Medical electrical equipme
25、nt - Part 2-1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV - - IEC 60601-2-4 2010 Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators
26、 EN 60601-2-4 2011 IEC 60601-2-44 +A1 2009 2012 Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography EN 60601-2-44 +A11 +A1 2009 2011 2012 BS EN 60601-2-68:2015EN 60601-2-68:2015 4 Publication Year
27、 Title EN/HD Year IEC 60731 2011 Medical electrical equipment - Dosimeters with ionization chambers as used in radiotherapy EN 60731 2012 IEC/TR 60788 2004 Medical electrical equipment - Glossary of defined terms - - IEC 60976 2007 Medical electrical equipment - Medical electron accelerators - Funct
28、ional performance characteristics EN 60976 2007 IEC 61217 2011 Radiotherapy equipment - Coordinates, movements and scales EN 61217 2012 IEC 61223-3-5 2004 Evaluation and routine testing in medical imaging departments - Part 3-5: Acceptance tests - Imaging performance of computed tomography X-ray equ
29、ipment EN 61223-3-5 2004 IEC 61262-7 1995 Medical electrical equipment - Characteristics of electro-optical X-ray image intensifiers - Part 7: Determination of the modulation transfer function EN 61262-7 1995 IEC 62083 2009 Medical electrical equipment - Requirements for the safety of radiotherapy t
30、reatment planning systems EN 62083 2009 IEC 62274 2005 Medical electrical equipment - Safety of radiotherapy record and verify systems EN 62274 2005 IEC 62366 2007 Medical devices - Application of usability engineering to medical devices - - IEC 62396-1 2012 Process management for avionics - Atmosph
31、eric radiation effects - Part 1: Accommodation of atmospheric radiation effects via single event effects within avionics electronic equipment - - IEC 62563-1 2009 Medical electrical equipment - Medical image display systems - Part 1: Evaluation methods EN 62563-1 2010 BS EN 60601-2-68:2015EN 60601-2
32、-68:2015 5 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 Standard covers all relevant essential requirem
33、ents 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 other EU Directives can be applied to the p
34、roducts falling within the scope of this standard. BS EN 60601-2-68:2015 2 IEC 60601-2-68:2014 IEC 2014 CONTENTS FOREWORD . 3 INTRODUCTION . 5 201.1 Scope, object and related standards . 7 201.2 Normative references 9 201.3 Terms and definitions 10 201.4 General requirements 18 201.5 General require
35、ments for testing ME EQUIPMENT . 19 201.6 Classification of me equipment and me systems . 19 201.7 ME EQUIPMENT identification, marking and documents 19 201.8 Protection against electrical HAZARDS from ME EQUIPMENT 25 201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS 28 201.
36、10 Protection against unwanted and excessive radiation HAZARDS 32 201.11 Protection against excessive temperatures and other HAZARDS 34 201.12 Accuracy of controls and instruments and protection against hazardous outputs . 34 201.13 Hazardous situations and fault conditions for me equipment . 34 201
37、.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) 35 201.15 Construction of me equipment . 35 201.16 ME SYSTEMS . 35 201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS 35 201.101 Reference data for X-IGRT . 36 201.102 X-IGRT IMAGING 40 201.103 IGRT analysis and correction . 47 203
38、RADIATION protection in diagnostic X-RAY EQUIPMENT . 51 206 Usability 52 Annex B (informative) Sequence of testing 54 Annex I (informative) ME SYSTEMS aspects . 54 Annex AA (informative) Particular guidance and rationale 55 Annex BB (informative) Measuring CTDIfree air. 57 Bibliography 58 Index of d
39、efined terms used in this standard . 59 Figure 201.101 PATIENT SUPPORT movements 53 Table 201.101 Data required in the technical description . 22 Table 201.102 Clauses and subclauses in this particular standard that require the provision of information in the ACCOMPANYING DOCUMENTS, INSTRUCTIONS FOR
40、 USE and the technical description . 23 Table 201.103 Example test pattern for CTDIfree air for kV . 45 BS EN 60601-2-68:2015IEC 60601-2-68:2014 IEC 2014 3 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ MEDICAL ELECTRICAL EQUIPMENT Part 2-68: Particular requirements for the basic safety and essential p
41、erformance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment FOREWORD 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising all na
42、tional 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 end and in addition to other activities, IEC publishes International Standards, Techni
43、cal 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 Committee interested in the subject dealt with may participate in this preparatory work.
44、 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 accordance with conditions determined by agreement between the two organizations. 2) T
45、he 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 all interested IEC National Committees. 3) IEC Publications have the form of recommendat
46、ions 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 responsible for the way in which they are used or for any misinterpretation by any end
47、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 regional publicati
48、on 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 marks of conformity. IEC is not responsible for any services carried out by independent
49、 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 experts 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 IE
