BS EN 60976-2007 Medical electrical equipment - Medical electron accelerators - Functional performance characteristics《医疗电气设备 医疗电子加速器 功能的特性特征》.pdf

1、Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 10/07/2008 09:17, Uncontrolled Copy, (c) BSIg49g50g3g38g50g51g60g44g49g42g3g58g44g55g43g50g56g55g3g37g54g44g3g51g40g53g48g44g54g54g44g50g49g3g40g59g38g40g51g55g3g36g54g3g51g40g53g48g44g55g55g40g39g3g37g60g3g38g50g51g60g53g44g42g43g55g3g47g36g58F

2、unctional performance characteristicsICS 11.040.50; 13.280Medical electrical equipment Medical electron accelerators BRITISH STANDARDBS EN 60976:2007BS EN 60976:2007Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 10/07/2008 09:17, Uncontrolled Copy, (c) BSIThis British Standard was published

3、under the authority of the Standards Policy and Strategy Committee on 30 April 2008 BSI 2008ISBN 978 0 580 55685 2Amendments/corrigenda issued since publicationDate CommentsA list of organizations represented on this committee can be obtained on request to its secretary.This publication does not pur

4、port to include all the necessary provisions of a contract. Users are responsible for its correct application.Compliance with a British Standard cannot confer immunity from legal obligations. National forewordThis British Standard is the UK implementation of EN 60976:2007. It is identical to IEC 609

5、76:2007. It supersedes BS EN 60976:2001 which is withdrawn.The UK participation in its preparation was entrusted by Technical Committee CH/62, Electromedical equipment in medical practice, to Subcommittee CH/62/3, Equipment for radiotherapy, nuclear medicine and radiation dosimetry.EUROPEAN STANDARD

6、 EN 60976 NORME EUROPENNE EUROPISCHE NORM December 2007 CENELEC European Committee for Electrotechnical Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung Central Secretariat: rue de Stassart 35, B - 1050 Brussels 2007 CENELEC - All right

7、s of exploitation in any form and by any means reserved worldwide for CENELEC members. Ref. No. EN 60976:2007 E ICS 11.040.50; 13.280 Supersedes EN 60976:1999 + A1:2000English version Medical electrical equipment - Medical electron accelerators - Functional performance characteristics (IEC 60976:200

8、7) Appareils lectromdicaux - Acclrateurs mdicaux dlectrons - Caractristiques fonctionnelles de performance (CEI 60976:2007) Medizinische elektrische Gerte - Medizinische Elektronenbeschleuniger - Apparative Qualittsmerkmale (IEC 60976:2007) This European Standard was approved by CENELEC on 2007-11-0

9、1. 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 national standards may be obtain

10、ed on application to the Central Secretariat 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 its own language and notified to the Centra

11、l Secretariat has the same status as the official versions. CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Mal

12、ta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 10/07/2008 09:17, Uncontrolled Copy, (c) BSIBS EN 60976:2007 2 Foreword The text of document 62C/429/FDIS, future edit

13、ion 2 of IEC 60976, prepared by SC 62C, Equipment for radiotherapy, 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 60976 on 2007-11-01. This European Standard supersede

14、s EN 60976:1999 + A1:2000. EN 60976:2007 includes the addition of performance standards and test methods relating to the following new technologies: dynamic beam delivery techniques, such as MOVING BEAM RADIOTHERAPY, INTENSITY-MODULATED RADIATION THERAPY (IMRT), IMAGE-GUIDED RADIOTHERAPY (IGRT) and

15、PROGRAMMABLE WEDGE FIELDS (PWF); STEREOTACTIC RADIOTHERAPY (SRT) / STEREOTACTIC RADIOSURGERY (SRS); use of ELECTRONIC IMAGING DEVICES. This standard, together with IEC/TR 60977, is to be used in conjunction with EN 60601-2-1. The following dates were fixed: latest date by which the EN has to be impl

16、emented at national level by publication of an identical national standard or by endorsement (dop) 2008-08-01 latest date by which the national standards conflicting with the EN have to be withdrawn (dow) 2010-11-01 In this standard, the following print types are used: requirements, compliance with

17、which can be tested, and definitions: in roman type; explanations, advice, general statements, exceptions and notes: in small roman type; test specifications and headings of sub-clauses: in italic type; TERMS USED THROUGHOUT THIS PARTICULAR STANDARD THAT HAVE BEEN LISTED IN THE INDEX OF DEFINED TERM

18、S AND DEFINED IN CLAUSE 3, OR IN OTHER STANDARDS: SMALL CAPITALS. Annex ZA has been added by CENELEC. _ Endorsement notice The text of the International Standard IEC 60976:2007 was approved by CENELEC as a European Standard without any modification. _ Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STAN

19、DARDS, 10/07/2008 09:17, Uncontrolled Copy, (c) BSI 3 CONTENTS INTRODUCTION H7 1 Scope . H8 2 Normative references H9 3 Terms and definitions H9 4 Environmental conditions. H13 4.1 General H13 4.2 Transport and storage H13 4.3 Power supply H13 5 General information to the USER. H13 5.1 Functional pe

20、rformance characteristics . H13 5.2 Available nominal energies and ABSORBED DOSE RATES H14 5.3 Available RADIATION FIELDS H14 5.4 NORMAL TREATMENT DISTANCE H14 5.5 Available WEDGE X-RAY FIELDS. H14 5.6 Available flattening FILTERS . H14 5.7 Availability H15 5.8 Influencing quantities H15 5.9 Mainten

21、ance. H15 5.10 Presentation. H15 5.11 Dimensions, clearances, within the RADIATION HEAD, and in the region RADIATION HEAD to ISOCENTRE, of BEAM LIMITING DEVICES . H15 5.12 IMRT H15 6 Standardized test conditions H16 6.1 General H16 6.2 Angle settings. H16 6.3 Properties and positioning of the PHANTO

22、M H16 6.4 Positioning of measuring points H16 6.5 RADIATION DETECTORS . H16 6.6 STANDARD MEASUREMENT DEPTHS . H17 6.7 RADIATION FIELDS H17 6.8 Adjustments during test H17 6.9 Use of RADIOGRAPHIC FILM or alternative imaging method . H17 7 DOSE MONITORING SYSTEM. H17 7.1 General H17 7.2 Reproducibilit

23、y H18 7.3 Proportionality H19 7.4 Dependence on angular positions . H20 7.5 Dependence on GANTRY rotation . H21 7.6 Dependence on the shape of the RADIATION FIELD H21 7.7 Stability of calibration . H22 7.8 Stability in MOVING BEAM RADIOTHERAPY H24 8 Depth ABSORBED DOSE characteristics. H25 8.1 X-RAD

24、IATION H25 8.2 ELECTRON RADIATION . H27 9 Uniformity of RADIATION FIELDS H30 BS EN 60976:2007Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 10/07/2008 09:17, Uncontrolled Copy, (c) BSI 4 9.1 X-RADIATION H30 9.2 ELECTRON RADIATION . H35 9.3 PENUMBRA of RADIATION FIELDS H37 10 Indication of RA

25、DIATION FIELDS H38 10.1 X-RADIATION H38 10.2 ELECTRON RADIATION . H44 10.3 Geometry and motion speeds of adjustable BLDs for X-RADIATION and ELECTRON RADIATION H45 10.4 Illuminance and PENUMBRA of the LIGHT FIELD. H46 11 Indication of the RADIATION BEAM AXIS . H47 11.1 General H47 11.2 Indication on

26、 entry to the PATIENT H48 11.3 Indication on exit from the PATIENT H50 12 ISOCENTRE . H51 12.1 Displacement of the RADIATION BEAM AXIS from the ISOCENTRE H51 12.2 Indication of the ISOCENTRE . H52 13 Indication of distance along the RADIATION BEAM AXIS H52 13.1 Indicating device. H52 13.2 Additional

27、 indicating device for equipment with variable distance between RADIATION SOURCE and ISOCENTRE and for non-isocentric equipment. H53 14 Zero position of rotational scales . H54 14.1 General H54 14.2 Information to the USER. H54 14.3 Tests H54 15 Congruence of opposed RADIATION FIELDS. H55 15.1 Infor

28、mation to the USER. H55 15.2 Test . H55 16 Movements of the PATIENT table . H56 16.1 General H56 16.2 Vertical movement of the table H56 16.3 ISOCENTRIC rotation of the table. H57 16.4 Parallelism of table rotational axes H57 16.5 Rigidity of the table. H58 17 ELECTRONIC IMAGING DEVICE (e.g. EPID) H

29、59 17.1 Information to the USER. H59 17.2 Tests H61 Annex A (informative) Format for presentation of functional performances values H74 Annex ZA (normative) Normative references to international publications with their corresponding European publications98 Index of defined terms . H95 Figure 1 Expla

30、natory diagram for the definition of wedge . H63 Figure 2 The rotary GANTRY . H64 Figure 3 The wall- or floor-mounted GANTRY. H65 Figure 4 The ceiling-mounted GANTRY H66 Figure 5 Flattened area (shown hatched) within the RADIATION FIELD. H67 BS EN 60976:2007Licensed Copy: Wang Bin, ISO/EXCHANGE CHIN

31、A STANDARDS, 10/07/2008 09:17, Uncontrolled Copy, (c) BSI 5 Figure 6 Examples of profiles of ABSORBED DOSE along the major axes or the diagonal axes H68 Figure 7 Explanatory diagram for flatness of the ELECTRON FIELD H69 Figure 8 A possible arrangement of equipment for the measurement of the ISOCENT

32、RE described in Clause 12 H70 Figure 9 Test 10.1.1.3. H71 Figure 10 RADIATION HEAD showing X-RADIATION BLDs and ACCESSORIES (see 4.11) H72 Figure 11 Multi-element BLD RADIATION FIELDS used for measurement of X-RADIATION PENUMBRA (see 8.3.2). H73 Table 1 Conditions for testing reproducibility . H18 T

33、able 2 Conditions for testing proportionality of the DOSE MONITORING SYSTEM H19 Table 3 Conditions for testing dependence of the DOSE MONITORING SYSTEM on equipment position. H20 Table 4 Conditions for testing dependence of the DOSE MONITORING SYSTEM on GANTRY rotation . H21 Table 5 Conditions for t

34、esting dependence on the shape of the RADIATION FIELD . H22 Table 6 Conditions for testing stability of calibration of the DOSE MONITORING SYSTEM. H23 Table 7 Conditions for testing stability of the DOSE MONITORING SYSTEM in MOVING BEAM RADIOTHERAPY . H25 Table 8 Conditions for testing depth dose ch

35、aracteristics. H26 Table 9 Conditions for testing depth dose characteristics. H28 Table 10 Conditions for testing stability of PENETRATIVE QUALITY of ELECTRON RADIATION H28 Table 11 Flattened area according to Figure 5 H30 Table 12 Conditions for testing flatness and symmetry of X-RAY FIELDS H31 Tab

36、le 13 Conditions for testing deviation of dose distribution of X-RAY FIELDS with angular position . H32 Table 14 Conditions for testing maximum ABSORBED DOSE ratio in the RADIATION FIELD H33 Table 15 Conditions for testing WEDGE FACTORS . H34 Table 16 Conditions for testing WEDGE ANGLES. H34 Table 1

37、7 Conditions for testing flatness, symmetry, deviation of dose distribution with angular position, and maximum ABSORBED DOSE ratio of ELECTRON FIELDS H36 Table 18 Conditions for film calibration H40 Table 19 Conditions for testing the numerical and the LIGHT FIELD-INDICATION . H41 Table 20 Condition

38、s for testing reproducibility of X-RAY FIELDS . H43 Table 21 Conditions for testing the LIGHT FIELD-INDICATOR for ELECTRON RADIATION. H45 Table 22 Conditions for testing geometry of the BEAM LIMITING SYSTEM. H47 Table 23 Conditions for testing the indication of the RADIATION BEAM AXIS on entry to th

39、e PATIENT H49 Table 24 Conditions for testing the indication of the RADIATION BEAM AXIS on exit from the PATIENT H50 BS EN 60976:2007Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 10/07/2008 09:17, Uncontrolled Copy, (c) BSI 6 Table 25 Conditions for testing indication of the ISOCENTRE H52 T

40、able 26 Conditions for testing vertical movement of the table . H57 Table 27 Conditions for testing ISOCENTRIC rotation of the table . H57 Table 28 Conditions for testing the angulation of rotational axes of the table H58 Table 29 Conditions for testing lateral rigidity of the table H59 BS EN 60976:

41、2007Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 10/07/2008 09:17, Uncontrolled Copy, (c) BSI 7 INTRODUCTION Standards containing safety requirements for medical ELECTRON ACCELERATORS have been published by the IEC, details of which will be found in Clause 2. The present standard specifies

42、 methods of testing and methods of disclosure of functional performance of medical ELECTRON ACCELERATORS intended for RADIOTHERAPY. It permits a direct comparison between the performance data of equipment of different MANUFACTURERS. Since this standard does not contain safety requirements, it has no

43、t been numbered in the IEC 60601 publication series. It describes aspects of functional performance of medical ELECTRON ACCELERATORS and the way in which they should be presented. It also includes test methods and conditions suitable for TYPE TESTS. These test methods are suggested test methods and

44、alternative methods may be equally appropriate, but the specified functional performance characteristics of medical ELECTRON ACCELERATORS shall be related to these test methods and conditions. Tests specified in this standard are not necessarily appropriate for ensuring that any individual medical E

45、LECTRON ACCELERATOR conforms to the declared functional performance during the course of its working lifetime. Guidance on the values which may be expected is given in the technical report, IEC 60977. This International Standard was first published in 1989. With the rapidly increasing use of medical

46、 ELECTRON ACCELERATORS equipped with multi-element BEAM LIMITING DEVICES (BLDs), amendments to both this standard and the associated report, IEC 60977, were published in 2000. Amendment 1 was intended mainly to address the basic performance issues associated with the applications of multi-element BL

47、Ds to static RADIATION FIELDS. This second edition includes the addition of performance standards and test methods relating to several relatively new technologies introduced within the last few years, including dynamic beam delivery techniques, such as MOVING BEAM RADIOTHERAPY, INTENSITY-MODULATED R

48、ADIATION THERAPY (IMRT), IMAGE-GUIDED RADIOTHERAPY (IGRT), and PROGRAMMABLE WEDGE FIELDS (PWF). Also included are STEREOTACTIC RADIOTHERAPY (SRT)/STEREOTACTIC RADIOSURGERY (SRS) and the use of certain ELECTRONIC IMAGING DEVICES. In recognition of the diversity of equipment produced by MANUFACTURERS

49、in each of these technologies, this second edition has specified performance standards, methods of test, and methods of disclosure of functional performance, that are as basic and generic as possible. MANUFACTURERS may add more detailed information and special tests of performance characteristics to each perfor