IEC 62083-2009 Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems《医用电气设备.放射治疗计划系统的安全要求》.pdf

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1、 IEC 62083Edition 2.0 2009-09INTERNATIONAL STANDARD NORME INTERNATIONALEMedical electrical equipment Requirements for the safety of radiotherapy treatment planning systems Appareils lectromdicaux Exigences de scurit pour les systmes de planification de traitement en radiothrapie IEC62083:2009 THIS P

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16、 contactez-nous: Email: csciec.ch Tl.: +41 22 919 02 11 Fax: +41 22 919 03 00 IEC 62083Edition 2.0 2009-09INTERNATIONAL STANDARD NORME INTERNATIONALEMedical electrical equipment Requirements for the safety of radiotherapy treatment planning systems Appareils lectromdicaux Exigences de scurit pour le

17、s systmes de planification de traitement en radiothrapie INTERNATIONAL ELECTROTECHNICAL COMMISSION COMMISSION ELECTROTECHNIQUE INTERNATIONALE UICS 11.040.60 PRICE CODECODE PRIXISBN 2-8318-1062-2 Registered trademark of the International Electrotechnical Commission Marque dpose de la Commission Elect

18、rotechnique Internationale 2 62083 IEC:2009 CONTENTS FOREWORD.4 INTRODUCTION.6 1 Scope.7 2 Normative references .7 3 Terms, definitions and abbreviations 8 3.1 Terms and definitions 8 3.2 Abbreviations 9 4 General 9 4.1 Development .9 4.2 Testing during installation9 5 ACCOMPANYING DOCUMENTS.10 6 Ge

19、neral 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 use11 6.5 Data limits .12 6.6 Protection against unauthorized modification.12 6.7 Correctness of data transfer 13

20、 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 BRACHYTHERAPY SOURCE MODEL .14 7.3 Dosimetric information.15 7.4 EQUIPMENT MODEL, BRACHYTHERAPY SOURCE MODEL acceptan

21、ce .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 interest .17 8.4 PATIENT ANATOMY MODEL acceptance .17 8.5 PATIENT ANATOMY MODEL deletion.18 9 TREATMENT PLANNING 18 9.

22、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 calculation 19 10.1 Algorithms used 19 10.2 Accuracy of algorithms 19 11 TREATMENT PLAN report .20 11.1 Incomple

23、te TREATMENT PLAN report 20 62083 IEC:2009 3 11.2 Information on the TREATMENT 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 (normat

24、ive) Hardware safety24 Annex B (informative) Imported and exported data.26 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 corr

25、elation 24 4 62083 IEC:2009 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ MEDICAL ELECTRICAL EQUIPMENT REQUIREMENTS FOR THE SAFETY OF RADIOTHERAPY TREATMENT PLANNING SYSTEMS FOREWORD 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising all n

26、ational 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, Techn

27、ical 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

28、. 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)

29、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 all interested IEC National Committees. 3) IEC Publications have the form of recommenda

30、tions 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

31、 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 publicat

32、ion shall be clearly indicated in the latter. 5) IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any equipment declared to be in conformity with an IEC Publication. 6) All users should ensure that they have the latest edition of this publication. 7)

33、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 cost

34、s (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 publications is indispensable for the correct applica

35、tion 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 Standard IEC 62083 has been prepared by IEC subcomm

36、ittee 62C: Equipment for radiotherapy, nuclear medicine and radiation dosimetry, of IEC technical committee 62: Electrical equipment in medical practice. This second edition replaces the first edition of IEC 62083, published in 2000. This edition constitutes a technical revision, which brings this s

37、tandard in line with changes to the other standards referred to in this standard. The text of this standard is based on the following documents: FDIS Report on voting 62C/473/FDIS 62C/479/RVD Full information on the voting for the approval of this standard can be found in the report on voting indica

38、ted in the above table. This publication has been drafted in accordance with the ISO/IEC Directives, Part 2. 62083 IEC:2009 5 In this standard, the following print types are used: requirements, compliance with which can be tested, and definitions: in roman type; explanations, advice, general stateme

39、nts, exceptions and notes: in small roman type; test specifications: in italic type; TERMS USED THROUGHOUT THIS STANDARD THAT HAVE BEEN LISTED IN THE INDEX OF DEFINED TERMS AND DEFINED IN CLAUSE 3, OR IN OTHER STANDARDS: SMALL CAPITALS. The committee has decided that the contents of this publication

40、 will remain unchanged until the maintenance result date indicated on the IEC web site under “http:/webstore.iec.ch“ in the data related to the specific publication. At this date, the publication will be reconfirmed; withdrawn; replaced by a revised edition, or amended. 6 62083 IEC:2009 INTRODUCTION

41、 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. It usually, but not necessarily, provides estimates of ABSORBED DOSE distribution i

42、n 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 RADIOTHERAPY. The output of an RTPS is used by appropriately QUALIFIED PERSONS as important

43、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 to PATIENTS should the resulting data be used for TREATMENT purposes. This standa

44、rd 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 algorithms are not addressed in this standard. These are dependent on many factor

45、s, 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 establishes the minimum requirements for the contents of the ACCOMPANYING DOCUMENTS that wi

46、ll 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. Consequently, this standard is written in an independent format rather than as a par

47、ticular 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 subjects be addressed by the MANUFACTURER through compliance with an appropriate s

48、tandard, 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 Clause 14). IEC 61217 gives guidance on the designation of ME EQUIPMENT movements

49、, 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 (see Clause 16). 62083 IEC:2009 7 MEDICAL ELECTRICAL EQUIPMENT REQUIREMENTS FOR THE SAFETY OF RADIOTHERAPY TREATMENT PLANNING SYSTEMS 1 Scope This International Standard applies to the design