BS EN 61168-1994 Medical electrical equipment - Particular requirements for performance - Methods of declaring functional performance characteristics of radiotherapy simulators《医用电.pdf

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1、BRITISH STANDARD BS EN 61168:1994 BS5724-3.129: 1994 IEC1168:1993 Medical electrical equipment Part 3: Particular requirements for performance Section 3.129 Methods of declaring functional performance characteristics of radiotherapy simulators The European Standard EN61168:1994 has the status of a B

2、ritishStandard UDC 615.849:616-073.75:621.3:620.1BSEN61168:1994 This BritishStandard, having been prepared under the directionof the Health CareStandards Policy Committee,waspublished under theauthority of the Standards Board and comes into effect on 15June1994 BSI01-2000 The following BSI reference

3、s relate to the work on this standard: Committee reference HCC81 Draft for comment92/52057 DC ISBN 0 580 23394 4 Cooperating organizations The European Committee for Standardization (CEN), under whose supervision this European Standard was prepared, comprises the national standards organizations of

4、the following countries: Austria Oesterreichisches Normungsinstitut Belgium Institut belge de normalisation Denmark Dansk Standardiseringsraad Finland Suomen Standardisoimisliito, r.y. France Association franaise de normalisation Germany Deutsches Institut fr Normung e.V. Greece Hellenic Organizatio

5、n for Standardization Iceland Technological Institute of Iceland Ireland National Standards Authority of Ireland Italy Ente Nazionale Italiano di Unificazione Luxembourg Inspection du Travail et des Mines Netherlands Nederlands Normalisatie-instituut Norway Norges Standardiseringsforbund Portugal In

6、stituto Portugus da Qualidade Spain Asociacin Espaola de Normalizacin y Certificacin Sweden Standardiseringskommissionen i Sverige Switzerland Association suisse de normalisation United Kingdom BritishStandards Institution Amendments issued since publication Amd. No. Date CommentsBSEN61168:1994 BSI

7、01-2000 i Contents Page Cooperating organizations Inside front cover National foreword ii Foreword 2 Text of EN61168 3 National annex NA (informative) Committees responsible Inside back cover National annex NB (informative) Cross-references Inside back coverBSEN61168:1994 ii BSI 01-2000 National for

8、eword This BritishStandard has been prepared under the direction of the Health Care Standards Policy Committee and is the English language version of EN61168:1994 Radiotherapy simulators Functional performance characteristics, published by the European Committee for Electrotechnical Standardization

9、(CENELEC). It is identical with IEC1168:1993 Radiotherapy simulators Functional performance characteristics, published by the International Electrotechnical Commission (IEC). It is simultaneously published as BS5724 Medical electrical equipment Section3.129:1994 Methods of declaring functional perfo

10、rmance characteristics of radiotherapy simulators. This Particular Standard thus forms part of the group of standards directed specifically at electrical equipment used in health care. This Particular Standard details procedures by which the functional performance characteristics of radiotherapy sim

11、ulators which use diagnostic X-ray equipment may be determined and specified. Guidance in the application of this standard is given in BS5724-3.129:Supplement1, which is published simultaneously. Annex A to this Particular Standard is for information only. Attention is drawn to BS5724-2.129 which sp

12、ecifies the particular requirements for the safety of radiotherapy simulators. Additional information. The following print types are used in this standard. Requirements, compliance with which can be tested, and definitions: in romantype. Explanations, advice and general statements: in small roman ty

13、pe. Terms defined in clause2 of BS5724-1, in clause2 of BS5724-2.129, in3.2 of this Particular Standard and in BS6641: SMALL CAPITALS. For the purposes of this BritishStandard, any references to IEC page numbers in the text should be ignored. Textual errors. When adopting the text of the Internation

14、al Standard, the textual errors listed below were discovered. They have been marked in the text and have been reported to IEC in a proposal to amend the text of the International Standard. In Table 9, after “ISOCENTRE” in the last column heading, should be inserted: “when the table top rotation is s

15、et to0 ”. The sentence immediately after Table 9 should be replaced by the following: “Half the difference of the instrument readings is equal to the angle of tilt of the table top rotation axis(5) relative to the ISOCENTRIC rotation axis(6) in the direction of the line joining these two axes. Half

16、the sum of the instrument readings is equal to the angle of tilt of the table top rotation axis(5) in the direction perpendicular to the line joining axes(5) and(6).” A British Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are responsible

17、 for their correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. Summary of pages This document comprises a front cover, an inside front cover, pagesi andii, theEN title page, pages2 to20, an inside back cover and a back cover. This standa

18、rd has been updated (see copyright date) and may have had amendments incorporated. This will be indicated in the amendment table on the inside front cover.EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN61168 February1994 UDC 615.849:616-073.75:621.3:620.1 Descriptors: Electromedical equipment,

19、simulator, radiotherapy, functional performance values English version Radiotherapy simulators Functional performance characteristics (IEC1168:1993) Simulateurs de radiothrapie Caractristiques fonctionnelles (CEI1168:1993) Strahlentherapie-Simulatoren Apparative Funktionsmerkmale (IEC1168:1993) This

20、 European Standard was approved by CENELEC on1992-12-09. 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 and bibliographical refer

21、ences concerning such national standards may be obtained 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 m

22、ember into its own language and notified to the Central Secretariat has the same status as the official versions. CENELEC members are the national electrotechnical committees of Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Por

23、tugal, Spain, Sweden, Switzerland and UnitedKingdom. 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 1994 Copyright reserved to CE

24、NELEC members Ref.No.EN61168:1994EEN61168:1994 BSI 01-2000 2 Foreword The text of document62C(CO)64, as prepared by Subcommittee62C: Equipment for radiotherapy, nuclear medicine and radiation dosimetry, of IECTechnical Committee62: Electrical equipment in medical practice, was submitted to the IEC-C

25、ENELEC parallel vote in February1992. The reference document was approved by CENELEC as EN61168 on9December1992. NOTESwitzerland and Finland have no obligation to implement this European Standard. The following dates were fixed: Annexes designated “normative” are part of the body of the standard. An

26、nexes designated “informative” are given only for information. In this standard, Annex A is informative and Annex ZA is normative. Contents Page Foreword 2 Introduction 3 1 Scope and object 3 2 Normative references 4 3 Terminology and definitions 4 4 Standardized test conditions 4 5 Indication of DE

27、LINEATED RADIATION FIELDS 5 6 Indication of DELINEATED RADIATION BEAM AXIS 7 7 ISOCENTRE 8 8 Indication of the distance along the DELINEATED RADIATION BEAM AXIS 10 9 Zero position of rotational scales 11 10 Congruence of opposed DELINEATED RADIATION FIELDS 12 11 Movements of the PATIENT SUPPORT 12 A

28、nnex A (informative) Format for presentationoffunctionalperformance values 16 Annex ZA (normative) Other internationalpublications quoted in this standardwith thereferences of therelevantEuropean publications 20 Page Figure 1 RADIOTHERAPY SIMULATOR movements 15 Table 1 Conditions for testing the num

29、erical field-indicator and the LIGHT FIELD-INDICATOR 5 Table 2 Conditions for testing reproducibilityofDELINEATED RADIATION FIELDS 6 Table 3 Conditions for testing the geometry of the DELINEATOR 7 Table 4 Conditions for testing the indication ofthe DELINEATED RADIATION BEAM AXIS on theENTRANCE SURFA

30、CE 8 Table 5 Conditions for testing the indication ofthe DELINEATED RADIATION BEAM AXIS on the exit surface 8 Table 6 Conditions for testing the displacement of the DELINEATED RADIATION BEAM AXIS from the TEST DEVICE or reference pointerindicating the ISOCENTRE 10 Table 7 Conditions for testing the

31、verticalmovement of the table top 13 Table 8 Conditions for testing the ISOCENTRIC rotation of the PATIENT SUPPORT 13 Table 9 Conditions for testing the parallelism ofrotational axes of the PATIENT SUPPORT 13 Table 10 Conditions for testing the PATIENT SUPPORT lateral rigidity 14 latest date of publ

32、ication ofan identical national standard (dop)1994-12-01 latest date of withdrawal ofconflicting national standards (dow)1994-12-01EN61168:1994 BSI 01-2000 3 Introduction This International Standard specifies methods of disclosure of and describes methods of test for functional performance of SIMULA

33、TORS intended for RADIOTHERAPY. It permits a direct comparison between the performance data of EQUIPMENT of different manufacture. Since this standard does not contain safety requirements it has not been numbered in the IEC601 Publication series. It describes aspects of functional performance of RAD

34、IOTHERAPY SIMULATORS and the way in which they should be presented. It also includes suggested test methods and conditions suitable for TYPE TESTS. Alternative methods may be equally appropriate, but the specified functional performance characteristics of the RADIOTHERAPY SIMULATORS shall be related

35、 to these test methods and conditions. Tests specified in this standard are not necessarily appropriate for ensuring that any individual RADIOTHERAPY SIMULATOR conforms with the declared functional performance during the course of its working lifetime. Guidance on the values which may be expected ar

36、e given in the technical report IEC1170:1993, Radiotherapy simulators Guidelines for functional performance characteristics. 1 Scope and object 1.1 Scope This International Standard applies to RADIOTHERAPY SIMULATORS which use diagnostic X-RAY EQUIPMENT to geometrically simulate a RADIOTHERAPY RADIA

37、TION BEAM so that the TREATMENT VOLUME to be irradiated during RADIOTHERAPY can be localized and the position and size of the therapeutic RADIATION FIELD can be confirmed. This standard applies to RADIOTHERAPY SIMULATORS using HIGH VOLTAGE GENERATORS operating at a voltage not exceeding400kV complyi

38、ng with IEC601-2-7. This standard applies to RADIOTHERAPY SIMULATORS intended exclusively for RADIOTHERAPY simulation as a prelude to intended RADIOTHERAPY and not for any other purposes such as general diagnostic purposes. The requirements in this standard are based on the assumption that the RADIO

39、THERAPY SIMULATOR consists of: a) a system for producing a beam of X-RADIATION not exceeding400kV which simulates the geometry of the RADIOTHERAPY RADIATION BEAM; b) a system for producing images of the transmitted X-RAY BEAM, either by RADIOGRAPHY or by RADIOSCOPY; c) an assembly which controls the

40、 size of the RADIATION BEAM and which delineates the intended treatment area; d) a mechanical structure that physically simulates the geometry and motions of a RADIOTHERAPY EQUIPMENT, and which supports an imaging system; e) a PATIENT SUPPORT system. This standard applies to EQUIPMENT intended for u

41、se under the supervision of a QUALIFIED PERSON. Except where otherwise stated this standard assumes that the RADIOTHERAPY SIMULATOR has an ISOCENTRIC GANTRY with no pitch or roll movement of the RADIATION HEAD. This standard specifies TYPE TESTS to be performed by the MANUFACTURER at the design and

42、construction stages of a RADIOTHERAPY SIMULATOR but does not specify SITE TESTS to be performed after installation at the USERS site. The accompanying technical report IEC1170, however, does suggest that many of the test procedures are appropriate for SITE TESTS. During the course of any test proced

43、ure only those adjustments of the RADIOTHERAPY SIMULATOR are permissible that can be carried out using controls normally accessible to the OPERATOR and which are regarded as forming part of the normal operation of the RADIOTHERAPY SIMULATOR. 1.2 Object The object of this standard is to: a) identify

44、geometric parameters which are critical for the accurate simulation of a RADIOTHERAPY treatment; b) recommend methods of measuring these parameters. It is recognized that inaccuracies in the test methods must be allowed for when assessing performance. However, it is not felt advisable to combine the

45、 errors into an overall performance tolerance but keep them separate in the expectation that more accurate test methods will be evolved. It is not intended that this standard should in any way inhibit the future development of new designs of EQUIPMENT which may have operating modes and parameters di

46、fferent from those described herein.EN61168:1994 4 BSI 01-2000 1.3 Environmental conditions 1.3.1 General Except where other allowable environmental conditions are stated in the ACCOMPANYING DOCUMENTS this standard applies to EQUIPMENT installed, used or kept in locations where the following environ

47、mental conditions prevail: a) the ambient temperature falls within the range10 C to40 C; b) the relative humidity falls within the range30% to75%; c) the atmospheric pressure falls within the range70kPa to110kPa(700mbar to1100mbar). 1.3.2 Transport and storage The allowable environmental conditions

48、for transport and storage shall be stated in the ACCOMPANYING DOCUMENTS. 2 Normative references The following normative documents contain provisions which, through reference in this text, constitute provisions of this International Standard. At the time of publication, the editions indicated were va

49、lid. All normative documents are subject to revision, and parties to agreements based on this International Standard are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below. Members of IEC and ISO maintain registers of currently valid International Standards. IEC601-1:1988, Medical electrical equipment Part1:General requirements for safety. Amendment1,1991 IEC601-2-7:1987, Medical electrical equipment Part2: Particular requirements for the safety of high volt