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1、BRITISH STANDARD BS EN 61168:1994 BS 5724-3.129: 1994 IEC 1168:1993 Medical electrical equipment Part 3: Particular requirements for performance Section 3.129 Methods of declaring functional performance characteristics of radiotherapy simulators The European Standard EN 61168:1994 has the status of
2、a British Standard UDC 615.849:616-073.75:621.3:620.1 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 08 02:24:34 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN 61168:1994 This British Standard, having been prepared under the direction of the Health Care Standards Policy Committee, was publish
3、ed under the authority of the Standards Board and comes into effect on 15 June 1994 BSI 01-2000 The following BSI references relate to the work on this standard: Committee reference HCC 81 Draft for comment 92/52057 DC ISBN 0 580 23394 4 Cooperating organizations The European Committee for Standardi
4、zation (CEN), under whose supervision this European Standard was prepared, comprises the national standards organizations of the following countries: AustriaOesterreichisches Normungsinstitut BelgiumInstitut belge de normalisation DenmarkDansk Standardiseringsraad FinlandSuomen Standardisoimisliito,
5、 r.y. FranceAssociation franaise de normalisation GermanyDeutsches Institut fr Normung e.V. GreeceHellenic Organization for Standardization IcelandTechnological Institute of Iceland IrelandNational Standards Authority of Ireland ItalyEnte Nazionale Italiano di Unificazione LuxembourgInspection du Tr
6、avail et des Mines NetherlandsNederlands Normalisatie-instituut NorwayNorges Standardiseringsforbund PortugalInstituto Portugus da Qualidade SpainAsociacin Espaola de Normalizacin y Certificacin SwedenStandardiseringskommissionen i Sverige SwitzerlandAssociation suisse de normalisation United Kingdo
7、mBritish Standards Institution Amendments issued since publication Amd. No.DateComments Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 08 02:24:34 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN 61168:1994 BSI 01-2000i Contents Page Cooperating organizationsInside front cover National foreword
8、ii Foreword2 Text of EN 611683 National annex NA (informative) Committees responsibleInside back cover National annex NB (informative) Cross-referencesInside back cover Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 08 02:24:34 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN 61168:1994 ii BSI
9、01-2000 National foreword This British Standard has been prepared under the direction of the Health Care Standards Policy Committee and is the English language version of EN 61168:1994 Radiotherapy simulators Functional performance characteristics, published by the European Committee for Electrotech
10、nical Standardization (CENELEC). It is identical with IEC 1168:1993 Radiotherapy simulators Functional performance characteristics, published by the International Electrotechnical Commission (IEC). It is simultaneously published as BS 5724 Medical electrical equipment Section 3.129:1994 Methods of d
11、eclaring functional performance 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 characteri
12、stics of radiotherapy simulators which use diagnostic X-ray equipment may be determined and specified. Guidance in the application of this standard is given in BS 5724-3.129:Supplement 1, which is published simultaneously. Annex A to this Particular Standard is for information only. Attention is dra
13、wn to BS 5724-2.129 which specifies 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 roman type. Explanations, advice and general
14、statements: in small roman type. Terms defined in clause 2 of BS 5724-1, in clause 2 of BS 5724-2.129, in 3.2 of this Particular Standard and in BS 6641: SMALL CAPITALS. For the purposes of this British Standard, any references to IEC page numbers in the text should be ignored. Textual errors. When
15、adopting the text of the International 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 inserte
16、d: “when the table top rotation is set to 0”. 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
17、the line joining these two axes. Half 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. U
18、sers of British Standards are responsible 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, pages i and ii, the EN title page, pages 2 to 20, an i
19、nside back cover and a back cover. This standard 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. Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 08 02:24:34 GMT+00:00 2006, Uncontrolled Copy,
20、 (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 61168 February 1994 UDC 615.849:616-073.75:621.3:620.1 Descriptors: Electromedical equipment, simulator, radiotherapy, functional performance values English version Radiotherapy simulators Functional performance characteristics (IEC 1168:
21、1993) Simulateurs de radiothrapie Caractristiques fonctionnelles (CEI 1168:1993) Strahlentherapie-Simulatoren Apparative Funktionsmerkmale (IEC 1168:1993) This European Standard was approved by CENELEC on 1992-12-09. CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which
22、 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 S
23、tandard 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 na
24、tional electrotechnical committees of Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. CENELEC European Committee for Electrotechnical Standardization Comit Europen de Norma
25、lisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung Central Secretariat: rue de Stassart 35, B-1050 Brussels 1994 Copyright reserved to CENELEC members Ref. No. EN 61168:1994 E Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 08 02:24:34 GMT+00:00 2006, Uncontrolled Copy, (
26、c) BSI EN 61168:1994 BSI 01-2000 2 Foreword The text of document 62C(CO)64, as prepared by Subcommittee 62C: Equipment for radiotherapy, nuclear medicine and radiation dosimetry, of IEC Technical Committee 62: Electrical equipment in medical practice, was submitted to the IEC-CENELEC parallel vote i
27、n February 1992. The reference document was approved by CENELEC as EN 61168 on 9 December 1992. 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. Annexes designated
28、“informative” are given only for information. In this standard, Annex A is informative and Annex ZA is normative. Contents Page Foreword2 Introduction3 1Scope and object3 2Normative references4 3Terminology and definitions4 4Standardized test conditions4 5Indication of DELINEATED RADIATION FIELDS5 6
29、Indication of DELINEATED RADIATION BEAM AXIS7 7ISOCENTRE8 8Indication of the distance along the DELINEATED RADIATION BEAM AXIS10 9Zero position of rotational scales11 10Congruence of opposed DELINEATED RADIATION FIELDS12 11Movements of the PATIENT SUPPORT12 Annex A (informative) Format for presentat
30、ion of functional performance values16 Annex ZA (normative) Other international publications quoted in this standard with the references of the relevant European publications20 Page Figure 1 RADIOTHERAPY SIMULATORmovements15 Table 1 Conditions for testing the numerical field-indicator and the LIGHT
31、FIELD-INDICATOR5 Table 2 Conditions for testing reproducibility ofDELINEATED RADIATION FIELDS6 Table 3 Conditions for testing the geometry of the DELINEATOR7 Table 4 Conditions for testing the indication of the DELINEATED RADIATION BEAM AXIS on theENTRANCE SURFACE8 Table 5 Conditions for testing the
32、 indication of the DELINEATED RADIATION BEAM AXIS on the exit surface8 Table 6 Conditions for testing the displacement of the DELINEATED RADIATION BEAM AXIS from the TEST DEVICE or reference pointer indicating the ISOCENTRE10 Table 7 Conditions for testing the vertical movement of the table top13 Ta
33、ble 8 Conditions for testing the ISOCENTRICrotation of the PATIENT SUPPORT13 Table 9 Conditions for testing the parallelism of rotational axes of the PATIENT SUPPORT13 Table 10 Conditions for testing the PATIENT SUPPORT lateral rigidity14 latest date of publication of an identical national standard(
34、dop) 1994-12-01 latest date of withdrawal of conflicting national standards(dow) 1994-12-01 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 08 02:24:34 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 61168:1994 BSI 01-20003 Introduction This International Standard specifies methods of disclosure o
35、f and describes methods of test for functional performance of SIMULATORS 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 IEC 601 Publ
36、ication series. It describes aspects of functional performance of RADIOTHERAPY 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 perfor
37、mance characteristics of the RADIOTHERAPY SIMULATORS shall be related 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
38、its working lifetime. Guidance on the values which may be expected are given in the technical report IEC 1170:1993, Radiotherapy simulators Guidelines for functional performance characteristics. 1 Scope and object 1.1 Scope This International Standard applies to RADIOTHERAPY SIMULATORS which use dia
39、gnostic X-RAY EQUIPMENT to geometrically simulate a RADIOTHERAPY RADIATION 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 HIG
40、H VOLTAGE GENERATORS operating at a voltage not exceeding 400 kV complying with IEC 601-2-7. 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
41、 requirements in this standard are based on the assumption that the RADIOTHERAPY SIMULATOR consists of: a) a system for producing a beam of X-RADIATION not exceeding 400 kV which simulates the geometry of the RADIOTHERAPY RADIATION BEAM; b) a system for producing images of the transmitted X-RAY BEAM
42、, either by RADIOGRAPHY or by RADIOSCOPY; c) an assembly which controls the 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)
43、a PATIENT SUPPORT system. This standard applies to EQUIPMENT intended for use 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
44、specifies TYPE TESTS to be performed by the MANUFACTURER at the design and 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 IEC 1170, however, does suggest that many of the test pro
45、cedures are appropriate for SITE TESTS. During the course of any test procedure 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 RADIOT
46、HERAPY SIMULATOR. 1.2 Object The object of this standard is to: a) identify 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
47、when assessing performance. However, it is not felt advisable to combine the 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
48、of new designs of EQUIPMENT which may have operating modes and parameters different from those described herein. Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 08 02:24:34 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 61168:1994 4 BSI 01-2000 1.3 Environmental conditions 1.3.1 General Except wh
49、ere other allowable environmental conditions are stated in the ACCOMPANYING DOCUMENTS this standard applies to EQUIPMENT installed, used or kept in locations where the following environmental conditions prevail: a) the ambient temperature falls within the range 10 C to 40 C; b) the relative humidity falls within the range 30 % to 75 %; c) the atmospheric pressure falls within the range 70 kPa to 110 kPa (700 mbar to 1 100 mbar). 1.3.2 Transport and storage The allowable environmental conditions for transport and storage sha