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1、JIS JAPANESE INDUSTRIAL STANDARD Translated and Published by Japanese Standards Association (JIRNJSA) Radiotherapy simulators-Functional perf o r ma n ce c h a rac t e r i s t i cs ICs 11.040.60 Reference number : JIS Z 4761 : 2005 (E) PROTECTEDBYCOPYRIGHT 28 S Copyright Japanese Standards Associati
2、on Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/12/2007 21:01:09 MDTNo reproduction or networking permitted without license from IHS -,-,- Z 4761 2005 Foreword This translation ,as been made based on the origina Japanese Industria Stan
3、dard established by the Minister of Health, Labour and Welfare and the Minister of Economy, Trade and Industry through deliberations at the Japanese Industrial Standards Committee according to the proposal of establishing a Japanese Industrial Standard from Japan Industries Association of Radiologic
4、al Systems (J1RA)lJapanese Standards Association (JSA), with a draft of Industrial Standard based on the provision of Article 12 Clause 1 of the Industrial Standardization Law. This Standard has been made based on IEC 61168 : 1993 Radiotherapy simulators- Functional perfonname characteristics for th
5、e purposes of making it easier to compare this Standard with International Standard; to prepare Japanese Industrial Standard conforming with International Standard; and to propose a draft of an International Standard which is based on Japanese Industrial Standard. Attention is drawn to the possibili
6、ty that some parts of this Standard may conflict with a patent right, application for a patent after opening to the public, utility model right or application for registration of utility model after opening to the public which have technical properties. The relevant Ministers and the Japanese Indust
7、rial Standards Committee are not responsible for identifying the patent right, application for a patent after opening to the public, utility model right or application for registration of utility model after opening to the public which have the said technical properties. Date of Establishment: 2005-
8、03-25 Date of Public Notice in Official Gazette: Investigated by: 2005-03-25 Japanese Industrial Standards Committee Standards Board Technical Committee on Medical Equipment JIS Z 4761 : 2005, First English edition published in 2005-10 Translated and published by: Japanese Standards Association 4-1-
9、24, Akasaka, Minato-ku, Tokyo, 107-8440 JAPAN In the event of any doubts arising as to the contents, the original JIS is to be the final authority. JSA 2005 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any forin or by any means, electr
10、onic or mechanical, including photocopying and microfilm, without permission in writing from the publisher. Printed in Japan M a system for producing images of the transmitted X-ray beam, either by radiography or by radioscopy; an assembly which controls the size of the radiation beam and which deli
11、neates the intended treatment area; a mechanical structure that physically simulates the geometry and motions of radiotherapy equipment, and which supports an imaging system; a patient support system This Standard applies to equipment intended for use under the supervision of a qualified person. Exc
12、ept 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 construction stages of a radiotherapy simulator but
13、 does not specify site tests to be performed after installation at the users site. The accompanying technical report Annex 1, 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 simu
14、lator 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. Remarks The International Standard corresponding to this Standard is as follows. In addition, symbols which d
15、enote the degree of correspondence in the contents between the relevant International Standard and JIS are IDT (identical), MOD (modified), and NEQ (not equivalent) according to ISO/IEC Guide 21. IEC 61 168 : 1993 Radiotherapy sinzulatoiis -Functional performance characteristics (MOD) 1.2 Object The
16、 object of this Standard is to: a) b) identi 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 errors into PROTECTED BY COPYRIGHT Copyright Japanese
17、Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/12/2007 21:01:09 MDTNo reproduction or networking permitted without license from IHS -,-,- 3 Z 4761 2005 an overall performance tolerance but keep them separate in the
18、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 different from those described herein. 1.3 Environmental conditions 1.3.1 Exce
19、pt 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 O C to 40 O C ; b) the relativ
20、e humidity falls within the range 30 % to 75 %; c) the atmospheuic pressure falls within the range 70 kPa to 110 kPa (700 mbar to 1 100 mbar). General 1.3.2 Transport and storage The allowable environmental conditions for transport and storage shall be stated in the accompanying documents. 2 Normati
21、ve references The following standards contain provisions which, through reference in this text, constitute provisions of this Standard. If the indication of the year of coming into effect or the year of publication is given to these referred standards, only the edition of the indicated year constitu
22、tes the provision of this Standard but the revision and amendment made thereafter do not apply. JIS T 0601- 1 : 1999 Medical electrical equipment-Part I: General requirements for safety Remarks IEC 60601-1 1988 Medical electrical equipmerzt-Part I : General requirements ,for safety, Amendment 1 : 19
23、93 and Amendment 2 : 1995 are identical with the said standard. JIS Z 4005 : 1991 Medical radiology-Terminology Remarks : IEC 60788 : 1984 Medical radiology-Terminology is identical with the said standard. JIS Z 4702 1 1999 General requirements for high-voltage generators of medical X-ray apparat us
24、 IEC 60601-2-7 1 1998 Medical electrical equipment-Part 2-7: Particular requirements for the safety o f high-voltage generators of diagnostic X-ray generators is identical with the said standard. Remarks 1 JIS Z 475 1-2-29 : 2005 Medical electrical equipmerit-Part 2-29: Particular requirements for t
25、he safety of radiotherapy simulators Remarks : IEC 60601-2-29 1 1999 Medical electrical equipment-Part 2-29: Particular requirements for the safety o f radiotherapy sirnulators is identical with the said standard. PROTECTEDBYCOPYRIGHT Copyright Japanese Standards Association Provided by IHS under li
26、cense with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/12/2007 21:01:09 MDTNo reproduction or networking permitted without license from IHS -,-,- 4 Z 4761 : 2005 3 Terminology and definitions 3.1 in JIS Z 4005. Terminology In this Standard terms printed in boldface typ
27、e are used as defined Other additional terms are listed in Annex AA of JIS Z 4751-2-29 and in 3.2 of this Standard. 1.nfoJ:m.a.tiQn .: . . . .Ann.ex .M. .of. JSS 3. . 4 7 5 . - . 2 : 2 9 .Is. att.3.che.d. as. Annex. 2. .(i:nform.3.tiv.e). 0fth:sst-andaXd: 3.2 applies : Definitions For the purpose of
28、 this Standard, the following additional definition delineated light field : for radiotherapy simulators, the area of the light field bounded by the delineator shadow and in a plane perpendicular to the X-ray beam axis 4 Standardized test conditions In determining performance characteristics in acco
29、rdance with this Standard, standardized test conditions according to 4.1 to 4.3 shall prevail, unless otherwise stated. The specified axes are given in fluine.l.toflure 3, Unless otheuwise stated all measurements shall be taken at either 80 cm or 100 cm source axis distance (SAD). 4.1 Angle and line
30、ar settings unless otheiwise specified (see. figuxs. -1 .to. -3) The following angles and linear settings are at zero gantry rotation, Axis O roll of radiation head, Axis 0 pitch of radiation head, Axis 0 rotation of the delineator, Axis isocentric rotation of the patient support, Axis 0 rotation of
31、 the table top, Axis 0 pitch of the table top, Axis 0 roll of the table top, Axis height of the table top, Direction 8 lateral displacement of the table top, Direction longitudinal displacement of the table top, Direction 0. If in this Standard the test conditions call for measurements to be made at
32、 angles of rotation of the gantry, Axis 0, or of the delineator, Axis I, of 90“ only, it is equally acceptable to use the angle of 270“. 4.2 Positioning of the measuring plane and radiation detectors Measurements are made, unless otherwise specified, in the plane normal to the delineated radiation b
33、eam axis PROTECTED BY COPYRIGHT Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/12/2007 21:01:09 MDTNo reproduction or networking permitted without license from IHS -,-,- 5 Z 4761 2005 and containi
34、ng the isocentre. Measurements are generally made with radiographic film. For geometric alignment tests other radiation detectors with adequate spatial resolution may be used. 4.3 Unless otherwise specified the tests shall be made with the small focal spot and the manufacturers recommended loading f
35、actors of the X-ray tube. Focal spot and loading factors 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 th
36、e user The accompanying documents shall state the maximum differences between the numerical field indication and the distances along the major axes of the opposing delineated radiation field edges at source axis distances specified in table 1. The maximum differences shall be given in millimetres or
37、 shall be expressed as a percentage 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 maximum differenceh) shall apply to all delineat
38、ed radiation fields for which the smaller dimension is equal to or greater than 3 cm and for all angular positions of the gantry and of the delineator. 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 sou
39、rce axis dis tance. Radiographic 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 dimens
40、ions shall be determined under the following conditions: The delineated radiation field shall be set using the numerical field-indicators. The edges of the delineated light field shall be marked on the radiographic film cover. PROTECTEDBYCOPYRIGHT Copyright Japanese Standards Association Provided by
41、 IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/12/2007 21:01:09 MDTNo reproduction or networking permitted without license from IHS -,-,- 6 Z 4761 : 2005 O“ 180“ O“ maximum maximum light field 45“ 10 x 10 * SAD Only for 180“ O“ 100 indicator and SO
42、 test (5.2.2) 10 x 10 maximum PROTECTED BY COPYRIGHT Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/12/2007 21:01:09 MDTNo reproduction or networking permitted without license from IHS -,-,- 7 Z 4
43、761 2005 Angular position of Gantry Delineator Axis ( 1 1 Axis O“ O“ 90“ O“ not available) and at the radiation source to measuring plane distance 1.5 times the value of the source axis distance. SAD Delineated radiation field cm X cm cm 20 x 20 100 20 x 20 100 All tests shall be carried out using b
44、oth small and large focal spots if available. The maximum distance for a) shall be given in millimetres for delineated radiation field up to 20 cm x 20 cm and shall be expressed as a percentage of its size for delineated radiation fields greater than 20 cm X 20 cm. The maximum distance for b) shall
45、be given in millimetres. The maximum difference shall apply for: all delineated radiation fields for which the smaller dimension is equal to or greater than 3 cm; all angles of rotation of the gantry and of the delineator; both large and small focal spots, if available. 5.2.2 5.3 Reproducibility Tes
46、t See 5.1.2, which includes the test of the light field-indicator. NOTE : This may be alternatively checked by the use of either the numerical indicator or the delineated light field. 5.3.1 Information to the user The accompanying documents shall state the maximum variation in millimetres of the siz
47、e of the delineated radiation field for repeated settings of the same numerical field-indications at 100 cm source axis dis tance. 5.3.2 For the set of test conditions given in table 2, the test according to 5.1.2 shall be carried out six times approaching the same setting of the numerical field-ind
48、icators alternately from larger and smaller indicated values. Test Table 2 Conditions for testing reproducibility of delineated radiation fields 5.4 Geometry of the delineator 5.4.1 state Information to the user For the delineator, the accompanying documents shall - the maximum angular deviation in
49、degrees of the opposing edges from being parallel; and the maximum angular deviation in degrees of adjacent edges from being at a right angle (90“). - PROTECTEDBYCOPYRIGHT Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/12/2007