1、I 3404583 0307854 3T3 EUROPEAN STANDARD EN 61168 NORMEEUROPENNE EUROPISCHE NORM February 1994 1JDC 615.849 : 616-073.75 : 621.3 620.1 Descriptors: Electromedical equipment, simulator, radiotherapy, functional performance values English version Radiotherapy simulators - Functional performance charact
2、eristics (IEC 1168 : 1993) Simulateurs de radiothrapie Caractristiques fonctionnelles (CE1 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
3、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 obtained on application to the Central Secretariat or to any CENEL
4、EC 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 Central Secretariat has the same status as the official versions.
5、CENELEC members are the national 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 Standardizat
6、ion Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung Central Secretariat: rue de Stassart 35, B-1050 Brussels O 1994 Copyright reserved to CENELEC members Ref. No. EN 61168 : 1994 E = 3404583 OL07855 23T H Page 2 EN 61168 : 1994 Foreword The text of do
7、cument 62C(C0)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 in February 1992. The reference document was approved by CE
8、NELEC as EN 61168 on 9 December 1992. NOTE. Switzerland and Finland have no obligation to implement this European Standard. The following dates were fixed: - latest date of publication of an identical national standard (dop) 1994-12-01 - latest date of withdrawal of conflicting national standards (d
9、ow) 1994-12-01 Annexes designated normative are part of the body of the standard. Annexes designated informative are given only for information. In this standard, annex A is informative and annex ZA is normative. Page 3 EN 61168 : 1994 E 3404583 0107856 176 CONTENTS Page INTRODUCTION . 4 Clause 1 2
10、3 4 5 6 7 8 9 10 11 Scope and object Normative references . Terminology and definitions Standardized test conditions . Indication Of DELINEATED RADIATION FIELDS Indication Of DELINEATED RADIATION BEAM AXIS ISOCENTRE Indication Of the distance along the DELINEATED RADIATION BEAM AXIS . Zero position
11、of rotational scales . CongruenCe Of opposed DELINEATED RADIATION FIELDS Movements Of the PATIENT SUPPORT _ 5 6 7 7 8 12 15 18 20 22 22 Figure I - RADIOTHERAPY SIMULATOR mOVementS 27 Annex A Format for presentation of functional performance values 28 Tables 1 2 3 4 5 6 7 8 9 10 Conditions for testin
12、g the numerical field-indicator and the LIGHT FIELD-INDICATOR . Conditions for testing reproducibility Of DELINEATED RADIATION FIELDS . Conditions for testing the geometry of the DELINEATOR . Conditions for testing the indication Of the DELINEATED RADIATION BEAM AXIS on the ENTRANCE SURFACE . Condit
13、ions for testing the indication Of the DELINEATED RADIATION BEAM AXIS on the exit su dace . . . . . . . . . . . . . . . . . . . . . . . . . . . . from the TEST DEVICE or reference pointer indicating the ISOCENTRE . Conditions for testing the displacement Of the DELINEATED RADIATION BEAM AXIS Conditi
14、ons for testing the vertical movement of the table top Conditions for testing the ISOCENTRIC fOtati0n Of the PATIENT SUPPORT . Conditions for testing the parallelism of rotational axes of the Conditions for testing the PATIENT SUPPORT lateral rigidity . : PATIENT SUPPORT 9 11 11 13 14 17 23 24 25 26
15、 Annex ZA (normative) Other international publications quoted in this standard with the references of the relevant European publications . . . . . . . . . . . . . 33 3404583 0307857 002 W Page 4 EN 61168 : 1994 INTRODUCTION This International Standard specifies methods of disclosure of and describes
16、 methods of test for functional performance of SIMULATORS intended for RADIOTHERAPY. It permits a di- rect 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 Publication serie
17、s. 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 performance charact
18、eristics 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 its working l
19、ifetime. Guidance on the values which may be expected are given in the technical report IEC 1170: 1 993, Radiotherapy simulators - Guidelines for functional performance characteristics. 6 3404583 0307858 T47 Page Fi EN 61168 : 1994 RADIOTHERAPY SIMULATORS - FUNCTIONAL PERFORMANCE CHARACTERISTICS 1 S
20、cope and object 1.1 Scope This International Standard applies to RADIOTHERAPY SIMULATORS which use diagnostic 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 th
21、erapeutic RADIATION FIELD can be confirmed. This standard applies to RADIOTHERAPY SIMULATORS Using HIGH VOLTAGE GENERATORS operating at a voltage not exceeding 400 kV complying with I EC 601 -2-7. This standard applies to RADIOTHERAPY SIMULATORS intended exCluSiVely for RADIOTHERAPY simulation as a
22、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 RADIOTHERAPY SIMULATOR Consists Of: a) a system for producing a beam of X-RADIATION not exceeding 400 kV which Simulates the geo
23、metry 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 size of the RADIATION BEAM and which delineates the intended treatment area; d) a mechanical structure that physically s
24、imulates the geometry and motions of a RADIOTHERAPY EQUIPMENT, and which SUppOftS an imaging System; e) a PATIENT SUPPORT System. This standard applies to EQUIPMENT intended for use under the SUpeWiSiOn Of a QUALIFIED PERSON. Except where otherwise stated this standard assumes that the RADIOTHERAPY
25、SIMULATOR has an ISOCENTRIC GANTRY with no pitch Of roll movement Of the RADIATION HEAD. This standard 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
26、USERS site. The accompanying technical report IEC 1170, however, does suggest that many of the test procedures 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
27、accessible to the OPERATOR and which are regarded as forming part of the normal Operation of the RADIOTHERAPY SIMULATOR. 3404583 0307859 985 Page 6 EN 61168 : 1994 1.2 Object The object of this standard is to: a) identify geometric parameters which are critical for the accurate simulation of a b) re
28、commend methods of measuring these parameters. RADIOTHERAPY treatment; 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 errors into an overall performance tolerance but keep them separate in the ex
29、pectation 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 different from those described herein. 1.3 Environmental conditions 1.3.1 Genera
30、l 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 environmental conditions prevail: a) the ambient temperature falls within the range 10 OC to 40 OC; b) the rela
31、tive 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 1 O0 mbar). 1.3.2 Transport and storage The allowable environmental conditions for transport and storage shall be stated in the 2 Normative references The following
32、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 valid. All normative documents are subject to revision, and parties to agreements based on this International St
33、andard are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below. Members of IEC and IS0 maintain registers of currently valid International Standards. ACCOMPANYING DOCUMENTS. IEC 601 -1 : 1988, Medical electrical equipment - Part 1
34、: General requirements for safety Amendment 1, 1991 IEC 601 -2-7: 1987, Medical electrical equipment - Part 2: Particular requirements for the safety of high voltage generators of diagnostic X-ray generators IEC 601 -2-29: 1993, Medical electrical equipment - Part 2: Particular requirements for the
35、safety of radiotherapy simulators IEC 788: 1984, Medical radiology - Terminology IEC 11 70: 1993, Radiotherapy simulators - Guidelines for functional performance characteristics 3404583 OL078b0 bT? Page 7 EN 61168 : 1994 3 Terminology and definitions 3.1 Terminology In this standard terms printed in
36、 CAPITALS are used as defined in IEC 788. Other additional terms are listed in Appendix AA of IEC 601-2-29 and in 3.2. 3.2 Definitions For the purpose of this International Standard, the following additional definition applies: DELINEATED LIGHT FIELD: For RADIOTHERAPY SIMULATORS, the area Of the LIG
37、HT FIELD bounded by the DELINEATOR shadow and in a plane perpendicular to the X-RAY BEAM AXIS. 4 Standardized test condltlons In determining performance characteristics in accordance with this standard, standardized test conditions according to 4.1 to 4.3 shall prevail, unless otherwise stated. The
38、specified axes are given in figure 1. Unless otherwise stated all measurements shall be taken at either 80 cm or 100 cm source axis distance (SAD). 4.1 Angle andlinear settings The following angles and linear settings are at zero unless otherwise stated (see figure 1: RADIOTHERAPY SIMULATOR mOVement
39、S): GANTRY rotation, his (1) roll Of RADIATION HEAD, hS (2) pitch Of RADIATION HEAD, his (3) rotation Of the DELINEATOR, his (4) ICOCENTRIC rotation Of the PATIENT SUPPORT, his (5) rotation of the table top, Axis (6) pitch of the table top, Axis (7) roll of the table top, Axis (8) height of the tabl
40、e top, Direction (9) lateral displacement of the table top, Direction (1 O) longitudinal displacement of the table top, Direction (1 1). this standard the test conditions call for measurements to be made at angles of rotation Of the GANTRY, Axis (I), or Of the DELINEATOR, his (4), Of 90“ Only, it is
41、 equally acceptable to use the angle of 270“. 3404583 01078bL 533 Page 8 EN 61168 : 1094 4.2 Positioning of the measuring plane and RADIATION DETECTORS Measurements are made, unless otherwise required, in the plane normal to the generally made with RADIOGRAPHIC FILM. For geometric alignment tests ot
42、her RADIATION DETECTORS with adequate spatial resolution may be used. DELINEATED RADIATION BEAM AXIS and COntaining the ISOCENTRE. Measurements are 4.3 FOCAL SPOT and LOADING FACTORS Unless otherwise required the tests shall be made with the small FOCAL SPOT and the MANUFACTURERS recommended LOADING
43、 FACTORS Of the X-RAY TUBE. 5 Indication Of DELINEATED RADIATION FIELDS 5.1 Numerical field-indicator The numerical field-indicator shall DISPLAY the dimensions Of the DELINEATED RADIATION FIELD at one or several specified source axis distance(s). 5.1.1 Information to the USER The ACCOMPANYING DOCUM
44、ENTS shall State the maximum differences between the DELINEATED RADIATION FIELD edges at SoUrCe axis distances specified in table f. numerical field indication and the distances along the major axes of the opposing The maximum differences shall be given in millimetres or shall be expressed as a perc
45、entage Of the Size Of the DELINEATED RADIATION FIELD. The maximum difference shall be given in mm for DELINEATED RADIATION FIELDS Up to 20 Cm x 20 Cm and in % for DELINEATED RADIATION FIELDS greater than 20 Cm x 20 Cm. The maXtnUm difference(s) shall apply to all DELINEATED RADIATION FIELDS for whic
46、h the GANTRY and Of the DELINEATOR. smaller dimension is equal to or greater than 3 cm and for all angular positions of the 5.1.2 Test NOTE - The numerical indicators of the DELINEATED RADIATION FIELD refer to the plane normal to the RADIATION BEAM AXIS at a specified source axis distance RADIOGRAPH
47、IC FILMS for these tests are placed SO that they are centred in the DELINEATED RADIATION FIELD at the axis Of rotation Of the GANTRY in a plane normal to the DELINEATED RADIATION BEAM AXIS. For the Set Of conditions given in table 1 the DELINEATED RADIATION FIELD dimensions shall be determined under
48、 the following conditions: The DELINEATED RADIATION FIELD shall be Set Using the nUmerCaI field-indicators. The edges Of the DELINEATED LIGHT FIELD shall be marked On the RADIOGRAPHIC FILM Cover. M 3404583 0107862 47T M Page 9 EN l168 : 1994 Angular position of GANTRY DELINEATOR Axis (1) Axis (4) go
49、o O“ 270“ 90“ O“ 135“ 180“ 180“ O“ 45“ 180“ 180“ O“ O“ SAD 6 source axis distance Table 1 - Conditions for testing the numerical field-indicator and the LIGHT FIELD-INDICATOR DELINEATED Distance RADIATION SAD source to film FIELD cm x cm cm cm 3x3 10 x 10 * 20 x 20 and 80 30 x 30 * SAD 1 O0 10 x 10 * 30 x 30 * 10 x 10 * minimum maximum SAD 10 x 10 * maximum maximum SAD 1 O0 and 80 lox 10“ maximum 1 O0 SAD lox 10 maximum and 80 Remark Only for numerical test (5.1.2) Only for LIGHT FIELD INDICATOR test (5.2.2) * These symmetrical fields shall be tested also in the
