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1、BRITISH STANDARD BS 5724-3.1: Supplement 1: 1990 IEC 977:1989 Incorporating Amendment No. 1 Medical electrical equipment Part 3: Particular requirements for performance Section 3.1 Methods of declaring functional performance characteristics of medical electron accelerators in the range 1 MeV to 50 M
2、eV Supplement 1: Guide to functional performance values ? Licensed Copy: sheffieldun sheffieldun, na, Fri Dec 01 13:58:13 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 5724-3.1:1990 This British Standard, having been prepared under the direction of the Health Care Standards Policy Committee, was pub
3、lished under the authority of the Board of BSI and comes into effect on 30 November 1990 BSI 25 March 2003 The following BSI references relate to the work on this standard: Committee reference HCC/81 Drafts for comment 85/53703 DC 85/53705 DC ISBN 0 580 18840 X Committees responsible for this Britis
4、h Standard The preparation of this British Standard was entrusted by the Health Care Standards Policy Committee (HCC/-) to Technical Committee HCC/81, upon which the following bodies were represented: Association of X-ray Equipment Manufacturers (BEAMA Ltd.) British Institute of Radiology College of
5、 Radiographers Department of Health Department of Trade and Industry (National Physical Laboratory) Institute of Physical Sciences in Medicine Institution of Electrical Engineers National Radiological Protection Board Royal College of Radiologists Amendments issued since publication Amd. No.DateComm
6、ents 1421225 March 2003 See national foreword Licensed Copy: sheffieldun sheffieldun, na, Fri Dec 01 13:58:13 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 5724-3.1:1990 BSI 25 March 2003 i Contents Page Committees responsibleInside front cover National forewordii Section 1. Introduction1 Section 2.
7、 General, type tests 2.1Format of Appendix B of the disclosure standard with suggested functional performance values3 2.2Rationale for functional performance values suggested by the Working Group20 Section 3. Acceptance tests 3.1Summary of suggested test methods for MEDICAL ELECTRON ACCELERATOR acce
8、ptance31 3.2Acceptance test conditions38 3.3Suggested equipment for acceptance tests and for subsequent periodic tests45 Section 4. Periodic tests 4.1Suggested set of periodic test methods and test conditions48 4.2Suggested frequency for periodic tests during working life of the ELECTRON ACCELERATOR
9、52 Figure 1 Cumulative errors in beam displacement28 Figure 2 PHANTOM position30 Figure 3 DOSE MONITORING SYSTEM proportionality32 Table 1 Summary of major tolerances in routine X-RAY THERAPY27 Publication(s) referred toInside back cover Licensed Copy: sheffieldun sheffieldun, na, Fri Dec 01 13:58:1
10、3 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 5724-3.1:1990 ii BSI 25 March 2003 National foreword This Supplement to Section 3.1 of BS 5724 has been prepared under the direction of the Health Care Standards Policy Committee. It is identical with IEC Publication 977, including amendment 1:2000, pu
11、blished in 1989 by the International Electrotechnical Commission (IEC). The start and finish of text introduced or altered by IEC amendment 1:2000 are indicated by tags !“. Tags indicating changes to text carry the number of the amendment. For example, text altered by IEC amendment 1 is indicated by
12、 !“. This Particular Standard, which is for use in conjunction with BS 5724-2.1 and BS 5724-3.1, gives guidance on the values of the functional performance characteristics of medical electron accelerators which may be declared by the manufacturer. It also gives recommendations to manufacturers for t
13、he values to be declared in accordance with BS 5724-3.1. Cross-references The British Standards which implement international or European publications referred to in this document may be found in the BSI Catalogue under the section entitled “International Standards Correspondence Index”, or by using
14、 the “Search” facility of the BSI Electronic Catalogue or of British Standards Online. Additional information. The following print types are used in this standard. Terms defined in clause 2 of BS 5724-1: SMALL CAPITALS. For the purposes of this British Standard, any references to IEC page numbers in
15、 the text should be ignored. Textual errors. When 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. Section 2. General, type
16、tests In 2.1 (page 3), paragraph 3, last line, “maxi” should be replaced by “max” and “mini” should be replaced by “min”. Format for presentation of functional performance values: Abbreviation of statement in disclosure standard In 7.2.1 (page 10), line 1, base depth should be replaced by “BASE DEPT
17、H”. 2.2 Rationale for functional performance values suggested by the Working Group In 5.1 (page 16), line 3, “value of ” should be replaced by “value, ,”. In 7.1.1 (page 17), paragraph 1, line 4, “flattening FILTER” should be replaced by “FIELD-FLATTENING FILTER”; this correction should also be made
18、 in paragraph 2, line 4, and in paragraph 3, line 3. In 7.1.1 (page 17), paragraph 2, line 3, “AXIS dose” should be replaced by “AXIS”. In 7.1.1 (page 17), paragraph 4, line 4, “therapy” should be replaced by “RADIOTHERAPY”. In 7.2.1 (page 18), paragraph 3, line 7, “plane” should be inserted after “
19、BASE DEPTH”. In 10.2 (page 21), paragraph 4, line 2, “scatter” should be replaced by “scatters” and in line 3 “bend” should be replaced by “bends”. In line 4, “RADIATION FIELD defining aperture” should be replaced by “BEAM LIMITING SYSTEM”. In Table 1 (page 27), section A, column 1, “12” should be r
20、eplaced by “11”; and in section B, column 2, “Dependence on equipment position” should be replaced by “Dependence on angular positions” and, in column 1, “6.1” should be replaced by “6.2.2” and “6.1.2” should be replaced by “7.1.2”. Section 3. Acceptance tests RR Licensed Copy: sheffieldun sheffield
21、un, na, Fri Dec 01 13:58:13 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 5724-3.1:1990 BSI 25 March 2003 iii 3.1 Summary of suggested test methods for MEDICAL ELECTRON ACCELERATOR acceptance In clause 5.1 (page 27), line 1, “” should be replaced by “R”; after line four, the first equation for s sho
22、uld be deleted. In clause 5.2 (page 27), paragraph 2, line 5, the first reference to “” should be replaced by “R”. In 5.6.2 (page 27), line 2, “a 4 Gy” should be replaced by “4 Gy”. In 7.2.2 (page 30), lines 3 and 4, the text “on the major axis of the RADIATION FIELD parallel to the GANTRY axis and”
23、 should be replaced by “on a major axis of the RADIATION FIELD at”. In 8.1.3 (page 31), line 2, “alternatively” should be replaced by “alternately”. In 10.1 b) (page 32), line 4, “surfaces” should be replaced by “surface”. In 10.2 (page 32), lines 1 and 2, “LIGHT FIELD-INDICATORS” should be replaced
24、 by “ISOCENTRE position indicators”. Section 4. Periodic tests 4.1 Suggested set of periodic test methods and test conditions In the table (page 44), last column, last line, “each” should be inserted between “ENERGY” and “periodic”; also, on page 47, second column, first line, “LIGHT FIELD indicatio
25、n” should be replaced by “ELECTRON FIELD indication (LIGHT FIELD)”. The first edition of BS 5724-3.1:1990 omitted two English language pages of IEC 60977:1989. These have been reintroduced with the incorporation of IEC amendment 1:2000. This publication does not purport to include all the necessary
26、provisions of a contract. Users of British Standards are responsible for its correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. R R Summary of pages This document comprises a front cover, an inside front cover, pages i to iv, pages 1 to
27、 55 and a back cover. The BSI copyright notice displayed in this document indicates when the document was last issued. Licensed Copy: sheffieldun sheffieldun, na, Fri Dec 01 13:58:13 GMT+00:00 2006, Uncontrolled Copy, (c) BSI iv blank Licensed Copy: sheffieldun sheffieldun, na, Fri Dec 01 13:58:13 G
28、MT+00:00 2006, Uncontrolled Copy, (c) BSI BS 5724-3.1:1990 BSI 25 March 2003 1 Section 1. Introduction The guidelines given in this report are recommendations both to manufacturers and to USERS. They provide guidance to manufacturers on the needs of radiotherapists in respect of the performance of E
29、LECTRON ACCELERATORS and they provide guidance to USERS wishing to check the manufacturers declared performance characteristics, to carry out acceptance tests and to check periodically the performance throughout the life of the equipment. IEC Publication 601-1 (1977) is a general standard for the sa
30、fety of medical electrical equipment1). It is supplemented by IEC Publication 601-2-1, a standard which lays down particular requirements for MEDICAL ELECTRON ACCELERATORS in the range of 1 MeV to 50 MeV, titled Section 1: General; Section 2: Radiation safety for equipment; Section 3: Electrical and
31、 mechanical safety for equipment. In addition, IEC Publication 976 has been issued as a disclosure standard. It is a standard which standardizes methods of declaring the MEDICAL ELECTRON ACCELERATOR functional performance characteristics. It standardizes the type test conditions and type test method
32、s to which manufacturers declared values of functional performance relate. A format for the presentation of functional performance values is contained in IEC Publication 976 as Appendix B. It is repeated herein as 2.1, with the addition of a set of suggested values which reflects the need for precis
33、ion in RADIOTHERAPY and the knowledge of what is reliably achievable technically. A corresponding rationale for the suggested values is presented in 2.2. In order to check whether each individual machine at the time of installation performs in a manner consistent with the set of functional performan
34、ce values declared by the manufacturer based upon his type test data, it is customary to perform a series of acceptance tests at the USERS site before the machine is put into full medical use. Because of limitations of time and test equipment, this series of acceptance tests is usually less extensiv
35、e than the type tests specified in the disclosure standard, IEC Publication 976. 3.1 contains a summary of suggested test methods for machine acceptance. These are consistent with the test methods of IEC Publication 976 but have been presented in a form which may be more suitable for use in hospital
36、s. For reasons of economy and time, the USER may prefer to have a more limited but still standardized test performed at the time of installation of the equipment. 3.2 contains a set of suggested acceptance (commissioning) test conditions. It should be emphasized that these test conditions are presen
37、ted only as examples and that a quite different set of test conditions may still be needed for the purpose of displaying the functional performance characteristics of the individual machine. During the working life of the MEDICAL ELECTRON ACCELERATOR, periodic tests are usually conducted by the USER
38、 to check whether the functional performance of the machine is satisfactory. Because the available machine time is limited, a highly abbreviated set of test conditions is essential. Individual tests should not be repeated any more or less frequently than can be justified by experience with the parti
39、cular machine or machine type. A set of suggested periodic test methods is presented in 4.1 and a list of suggested periodic tests during the working life of the MEDICAL ELECTRON ACCELERATOR and suggested intervals between such tests is presented in 4.2. The manufacturer may recommend different inte
40、rvals or additional or different tests, depending on the special requirements of the MEDICAL ELECTRON ACCELERATOR in question. 1)The second edition has been published in 1988. Licensed Copy: sheffieldun sheffieldun, na, Fri Dec 01 13:58:13 GMT+00:00 2006, Uncontrolled Copy, (c) BSI 2 blank Licensed
41、Copy: sheffieldun sheffieldun, na, Fri Dec 01 13:58:13 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 5724-3.1:1990 BSI 25 March 2003 3 Section 2. General, type tests 2.1 Format of Appendix B of the disclosure standard with suggested functional performance values Introduction The purpose of 2.1 is to
42、 provide a suggested format for the presentation of functional performance values corresponding to the standardized statements of functional performance in the disclosure standard, IEC Publication 976. USERS of MEDICAL ELECTRON ACCELERATORS may find this format useful in getting information from the
43、 manufacturer on the expected performance, in recording acceptance test values measured at the time of installation and in periodic testing of performance during the working life of the machine. Manufacturers may find it useful in declaring the functional performance values for their particular type
44、s of MEDICAL ELECTRON ACCELERATORS in response to IEC Publication 976. Although the manufacturer may use his own set of type test methods in developing functional performance data, he should make sure that the functional performance values which he declares would be met if the test methods of IEC Pu
45、blication 976 were used. It is not suggested that a manufacturer should provide information to USERS from his type test in any greater detail than a simple declaration of these functional performance values. As a result of extensive deliberations by Working Group 1 of IEC Sub-Committee 62C, a set of
46、 suggested values of functional performance was agreed upon with respect to the standardized statements of IEC Publication 976. These suggested values are shown in parentheses for each relevant clause. For Clauses 6 and 7, the suggested tolerance values are given only for NOMINAL ENERGIES in the ran
47、ge from 3 MeV to 50 MeV, since this range covers most of the practice with MEDICAL ELECTRON ACCELERATORS. Tolerances are designated where they represent permissible deviations in more than one direction from a desired point or value. The designation is not used where the tolerance represents permiss
48、ible deviation in any one direction between two points or values. The abbreviations “maxi”2) and “mini” are used for “maximum” and “minimum”, respectively. In addition to declaring functional performance values, for which this format is suitable, IEC Publication 976 also calls for the following othe
49、r items to be provided in the ACCOMPANYING DOCUMENTS: IEC Publication 601-2-1 also calls for certain information to be provided in the ACCOMPANYING DOCUMENTS. 2)See national foreword for details of textual error. ClauseItem 3.6Influencing quantities 6.1.3.1Isodose charts for X-RADIATION, information to the USER 6.2.4.1Isodose charts for ELECTRON RADIATION, information to the USER 7.1.5.1X-RAY FIELDS with WEDGE FILTER, information to the USER Licensed Copy: sheffieldun sheffieldun, na, Fri Dec 0