BS EN 62083-2009 Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems《医用电气设备 放射线疗法处理计划系统的安全性要求》.pdf

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1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationMedical electrical equipment Requirements for the safety ofradiotherapy treatment planningsystemsBS EN 62083:2009Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 12/07/2010

2、 02:49, Uncontrolled Copy, (c) BSINational forewordThis British Standard is the UK implementation of EN 62083:2009. It is identical to IEC 62083:2009. It supersedes BS EN 62083:2001, which will be withdrawn on 1 November 2012.The UK participation in its preparation was entrusted by Technical Committ

3、eeCH/62, Electrical Equipment in Medical Practice, to Subcommittee CH/62/3,Equipment for radiotherapy, nuclear medicine and radiation 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 necess

4、ary provisions of acontract. Users are responsible for its correct application. BSI 2010ISBN 978 0 580 60073 9ICS 11.040.60Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of the StandardsPolicy and Strategy Commi

5、ttee on 31 March 2010.Amendments issued since publicationAmd. No. Date Text affectedBRITISH STANDARDBS EN 62083:2009Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 12/07/2010 02:49, Uncontrolled Copy, (c) BSIEUROPEAN STANDARD EN 62083 NORME EUROPENNE EUROPISCHE NORM December 2009 CENELEC Euro

6、pean Committee for Electrotechnical Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung Central Secretariat: Avenue Marnix 17, B - 1000 Brussels 2009 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for

7、CENELEC members. Ref. No. EN 62083:2009 E ICS 11.040.60 Supersedes EN 62083:2001English version Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems (IEC 62083:2009) Appareils lectromdicaux - Exigences de scurit pour les systmes de planification de tr

8、aitement en radiothrapie (CEI 62083:2009) Medizinische elektrische Gerte - Festlegungen fr die Sicherheit von Bestrahlungsplanungssystemen (IEC 62083:2009) This European Standard was approved by CENELEC on 2009-11-01. CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations whic

9、h 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 Central Secretariat or to any CENELEC member. This European

10、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 Central Secretariat has the same status as the official versions. CENELEC members are the n

11、ational electrotechnical committees of Austria, Belgium, Bulgaria, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sw

12、eden, Switzerland and the United Kingdom. BS EN 62083:2009Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 12/07/2010 02:49, Uncontrolled Copy, (c) BSIEN 62083:2009 - 2 - Foreword The text of document 62C/473/FDIS, future edition 2 of IEC 62083, prepared by SC 62C, Equipment for radiotherapy,

13、nuclear medicine and radiation dosimetry, of IEC TC 62, Electrical equipment in medical practice, was submitted to the IEC-CENELEC parallel vote and was approved by CENELEC as EN 62083 on 2009-11-01. This European Standard supersedes EN 62083:2001. EN 62083:2009 constitutes a technical revision, whi

14、ch brings this standard in line with changes to the other standards referred to in this standard. The following dates were fixed: latest date by which the EN has to be implemented at national level by publication of an identical national standard or by endorsement (dop) 2010-08-01 latest date by whi

15、ch the national standards conflicting with the EN have to be withdrawn (dow) 2012-11-01 This European Standard has been prepared under a mandate given to CENELEC by the European Commission and the European Free Trade Association and covers essential requirements of EC Directive MDD (93/42/EEC). See

16、Annex ZZ. In this standard, the following print types are used: requirements, compliance with which can be tested, and definitions: in roman type; explanations, advice, general statements, exceptions and notes: in small roman type; test specifications: in italic type; TERMS USED THROUGHOUT THIS STAN

17、DARD THAT HAVE BEEN LISTED IN THE INDEX OF DEFINED TERMS AND DEFINED IN CLAUSE 3, OR IN OTHER STANDARDS: SMALL CAPITALS. Annexes ZA and ZZ have been added by CENELEC. _ Endorsement notice The text of the International Standard IEC 62083:2009 was approved by CENELEC as a European Standard without any

18、 modification. _ BS EN 62083:2009Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 12/07/2010 02:49, Uncontrolled Copy, (c) BSI- 3 - EN 62083:2009 Annex ZA (normative) Normative references to international publications with their corresponding European publications The following referenced docu

19、ments are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. NOTE When an international publication has been modified by common modificatio

20、ns, indicated by (mod), the relevant EN/HD applies. Publication Year Title EN/HD Year IEC 60601-1 2005 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance EN 60601-1 2006 IEC 60601-1-2 (mod) -1)Medical electrical equipment - Part 1-2: General requir

21、ements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests EN 60601-1-2 20072)IEC 60601-2-1 2009 Medical electrical equipment - Part 2-1: Particular requirements for the basic safety and essential performance of electron accelerato

22、rs in the range 1 MeV to 50 MeV - - IEC 60601-2-11 1997 Medical electrical equipment - Part 2-11: Particular requirements for the safety of gamma beam therapy equipment EN 60601-2-11 1997 IEC/TR 60788 2004 Medical electrical equipment - Glossary of defined terms - - IEC 60950-1 (mod) -1)Information

23、technology equipment - Safety - Part 1: General requirements EN 60950-1 + A11 20062)2009 IEC 61000-4-1 -1)Electromagnetic compatibility (EMC) - Part 4-1: Testing and measurement techniques - Overview of IEC 61000-4 series EN 61000-4-1 20072)IEC 61000-4-2 -1)Electromagnetic compatibility (EMC) - Part

24、 4-2: Testing and measurement techniques - Electrostatic discharge immunity test EN 61000-4-2 20092)IEC 61000-4-3 -1)Electromagnetic compatibility (EMC) - Part 4-3: Testing and measurement techniques - Radiated, radio-frequency, electromagnetic field immunity test EN 61000-4-3 20062)IEC 61000-4-4 -1

25、)Electromagnetic compatibility (EMC) - Part 4-4: Testing and measurement techniques - Electrical fast transient/burst immunity test EN 61000-4-4 20042)IEC 61217 -1)Radiotherapy equipment - Coordinates, movements and scales EN 61217 19962)IEC 62304 -1)Medical device software - Software life-cycle pro

26、cesses EN 62304 + corr. November 20062)2008 1)Undated reference. 2)Valid edition at date of issue. BS EN 62083:2009Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 12/07/2010 02:49, Uncontrolled Copy, (c) BSIEN 62083:2009 - 4 - Publication Year Title EN/HD Year IEC 62366 2007 Medical devices -

27、 Application of usability engineering to medical devices EN 62366 2008 ICRU Report 42 1987 Use of Computers in External Beam Radiotherapy Procedures with High Energy Photons and Electrons - - BS EN 62083:2009Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 12/07/2010 02:49, Uncontrolled Copy,

28、(c) BSI- 5 - EN 62083:2009 Annex ZZ (informative) Coverage of Essential Requirements of EC 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 ess

29、ential requirements as given in Annex I of the EC Directive 93/42/EEC. Compliance with this standard provides one means of conformity with the specified essential requirements of the Directive concerned. WARNING: Other requirements and other EC Directives may be applicable to the products falling wi

30、thin the scope of this standard. BS EN 62083:2009Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 12/07/2010 02:49, Uncontrolled Copy, (c) BSI 2 62083 IEC:2009 CONTENTS INTRODUCTION.6 1 Scope.7 2 Normative references .7 3 Terms, definitions and abbreviations 8 3.1 Terms and definitions 8 3.2 A

31、bbreviations 9 4 General 9 4.1 Development .9 4.2 Testing during installation9 5 ACCOMPANYING DOCUMENTS.10 6 General requirements for operational safety .11 6.1 Distances and linear and angular dimensions11 6.2 RADIATION quantities11 6.3 Date and time format.11 6.4 Protection against unauthorized us

32、e11 6.5 Data limits .12 6.6 Protection against unauthorized modification.12 6.7 Correctness of data transfer 13 6.8 Coordinate systems and scales .13 6.9 Saving and archiving data .13 7 RADIOTHERAPY TREATMENT EQUIPMENT MODELLING and BRACHYTHERAPY SOURCE MODELLING 14 7.1 EQUIPMENT MODEL 14 7.2 BRACHY

33、THERAPY SOURCE MODEL .14 7.3 Dosimetric information.15 7.4 EQUIPMENT MODEL, BRACHYTHERAPY SOURCE MODEL acceptance .15 7.5 EQUIPMENT MODEL, BRACHYTHERAPY SOURCE MODEL deletion.16 8 ANATOMY MODELLING .16 8.1 Data acquisition 16 8.2 Coordinate systems and scales .16 8.3 Contouring of regions of interes

34、t .17 8.4 PATIENT ANATOMY MODEL acceptance .17 8.5 PATIENT ANATOMY MODEL deletion.18 9 TREATMENT PLANNING 18 9.1 General requirements18 9.2 TREATMENT PLAN preparation .18 9.3 TREATMENT PLAN identification .18 9.4 TREATMENT PLAN deletion.19 9.5 Electronic signatures.19 10 ABSORBED DOSE distribution c

35、alculation 19 10.1 Algorithms used 19 10.2 Accuracy of algorithms 19 11 TREATMENT PLAN report .20 11.1 Incomplete TREATMENT PLAN report 20 BS EN 62083:2009Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 12/07/2010 02:49, Uncontrolled Copy, (c) BSI62083 IEC:2009 3 11.2 Information on the TREAT

36、MENT PLAN report .20 11.3 Transmitted TREATMENT PLAN information.21 12 General hardware diagnostics 21 13 Data and code 22 14 Human errors in software design 22 15 Change in software versions.22 16 USE ERRORS23 Annex A (normative) Hardware safety24 Annex B (informative) Imported and exported data.26

37、 Bibliography27 Index of defined terms 28 Table 1 Clauses and subclauses in this standard that require the provision of information in the ACCOMPANYING DOCUMENTS and the technical description 10 Table A.1 Table indicating correlation 24 BS EN 62083:2009Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STA

38、NDARDS, 12/07/2010 02:49, Uncontrolled Copy, (c) BSI 6 62083 IEC:2009 INTRODUCTION A RADIOTHERAPY TREATMENT PLANNING SYSTEM (RTPS) is a device, usually a PROGRAMMABLE ELECTRICAL MEDICAL SYSTEM that is used to simulate the application of RADIATION to a PATIENT for a proposed RADIOTHERAPY TREATMENT. I

39、t usually, but not necessarily, provides estimates of ABSORBED DOSE distribution in human tissue using a particular algorithm or algorithms. These estimations, referred to in this International Standard as ABSORBED DOSE distributions, are used by a QUALIFIED PERSON in planning a course of RADIOTHERA

40、PY. The output of an RTPS is used by appropriately QUALIFIED PERSONS as important information in RADIOTHERAPY TREATMENT PLANNING. Inaccuracies in the input data, the limitations of the algorithms, errors in the TREATMENT PLANNING process, or improper use of output data, may represent a safety HAZARD

41、 to PATIENTS should the resulting data be used for TREATMENT purposes. This standard defines requirements to be complied with by MANUFACTURERS in the design and construction of an RTPS in order to provide protection against the occurrence of such HAZARDS. SPECIFIC types of input data and calculation

42、 algorithms are not addressed in this standard. These are dependent on many factors, such as available technology, RESPONSIBLE ORGANIZATION preference, and the type of TREATMENT being planned. However, this standard establishes the safety requirements that are common to algorithms. It also establish

43、es the minimum requirements for the contents of the ACCOMPANYING DOCUMENTS that will permit the OPERATOR to make informed choices during the TREATMENT PLANNING process. Generally, an RTPS is not used in the presence of PATIENTS, so it is not MEDICAL ELECTRICAL EQUIPMENT as defined by IEC 60601-1. Co

44、nsequently, this standard is written in an independent format rather than as a particular standard to IEC 60601-1. Relationship to other standards The BASIC SAFETY of hardware, such as for protection against electric shock and fire, and for assuring ELECTROMAGNETIC COMPATIBILITY requires that these

45、subjects be addressed by the MANUFACTURER through compliance with an appropriate standard, depending upon the nature and environment of the hardware used for the RTPS. See Annex A for hardware safety standards. A RTPS is principally a software application for medical purposes. IEC 62304 applies (see

46、 Clause 14). IEC 61217 gives guidance on the designation of ME EQUIPMENT movements, the marking of scales, their zero position and the direction of movement with increasing value. The means of applying IEC 61217 are SPECIFIED in appropriate clauses and subclauses of this standard. IEC 62366 applies

47、(see Clause 16). BS EN 62083:2009Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 12/07/2010 02:49, Uncontrolled Copy, (c) BSI62083 IEC:2009 7 MEDICAL ELECTRICAL EQUIPMENT REQUIREMENTS FOR THE SAFETY OF RADIOTHERAPY TREATMENT PLANNING SYSTEMS 1 Scope This International Standard applies to the

48、design, manufacture and some installation aspects of a radiotherapy treatment planning systems(RTPS) for use in RADIOTHERAPY TREATMENT PLANNING in human medical practice; that imports data either through input by the OPERATOR or directly from other devices; that outputs data either in printed form f

49、or review or directly to other devices; and which is intended to be for NORMAL USE, under the authority of appropriately licensed or QUALIFIED PERSONS, by OPERATORS having the required skills and training; maintained in accordance with the recommendations given in the INSTRUCTIONS FOR USE, and used within the environmental and electrical supply conditions SPECIFIED in the technical description. 2 Normative references The following referenced documents are indispensable for the applic