1、BRITISH STANDARD BS EN 61303:1997 IEC 1303:1994 Medical electrical equipment Radionuclide calibrators Particular methods for describing performance The European Standard EN 61303:1995 has the status of a British Standard ICS 11.040.50BSEN61303:1997 This British Standard, having beenprepared under th
2、e direction of the Health and EnvironmentSector Board, was published under the authority of theStandards Board and comes intoeffect on 15 June 1997 BSI 10-1999 The following BSI references relate to the work on this standard: Committee reference: CH/82 Draft for comment: 94/504063 DC ISBN 0 580 2763
3、0 9 Committees responsible for this BritishStandard The preparation of this British Standard was entrusted by Technical Committee CH/82, Nuclear medicine instrumentation, upon which the following bodies were represented: Association of X-ray Equipment Manufacturers (BEAMA Ltd.) British Institute of
4、Radiology British Nuclear Medicine Society College of Radiographers Department of Health Institute of Physics and Engineering in Medicine and Biology Institution of Electrical Engineers Amendments issued since publication Amd. No. Date CommentsBSEN61303:1997 BSI 10-1999 i Contents Page Committees re
5、sponsible Inside front cover National foreword ii Foreword 2 Text of EN 61303 3 List of references Inside back coverBSEN61303:1997 ii BSI 10-1999 National foreword This British Standard has been prepared by Technical Committee CH/82. It is the English language version of EN 61303:1995 Medical electr
6、ical equipment Radionuclide calibrators Particular methods for describing performance, published by the European Committee for Electrotechnical Standardization (CENELEC). It is identical with IEC 1303:1994 published by theInternational Electrotechnical Commission (IEC). Additional information. The f
7、ollowing print types are used in this standard. Requirements, with which compliance can be tested, and definitions: in roman type. Explanations, advice, general statements, exceptions, and references: in small roman type. Test procedures: in italic type. Terms defined in clause 2 of this standard or
8、 in BS 6641: SMALL CAPITALS. A British Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are responsible for their correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. Cross-refere
9、nces Publication referred to Corresponding British Standard IEC 788:1984 BS 6641:1985 Glossary of medical radiology terms Summary of pages This document comprises a front cover, an inside front cover, pagesi andii, theENtitlepage,pages2 to12, aninside back cover and a back cover. This standard has b
10、een 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 EN 61303 January 1995 ICS 11.040.50 Descriptors: Medical electrical equipment, radionuclide calibrators
11、, performance, test English version Medical electrical equipment Radionuclide calibrators Particular methods for describing performance (IEC 1303:1994) Appareils lectromdicaux Calibrateurs de radionuclides Mthodes particulires pour dcrire les performances (CEI 1303:1994) Medizinische elektrische Ger
12、te Aktivimeter Spezielle Verfahren zur Bestimmung der Leistungsparameter (IEC 1303:1994) This European Standard was approved by CENELEC on 1994-12-06. CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the st
13、atus 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 Standard exists in three official versions (English, French, German
14、). 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 national electrotechnical committees of Austria, Belgium, Denmark, F
15、inland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and UnitedKingdom. CENELEC European Committee for Electrotechnical Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische
16、Normung Central Secretariat: rue de Stassart 35, B-1050 Brussels 1995 Copyright reserved to CENELEC members Ref. No. EN 61303:1995 EEN61303:1995 BSI 10-1999 2 Foreword The text of document 62C(CO)77, future edition 1 ofIEC 1303, prepared by SC 62C, Equipment for radiotherapy, nuclear medicine and ra
17、diation dosimetry, of IEC TC 62, Electrical equipment inmedical practice, was submitted to the IEC-CENELEC parallel vote and was approved by CENELEC as EN 61303 on 1994-12-06. The following dates were fixed: Annexes designated “normative” are part of the body of the standard. Annexes designated “inf
18、ormative” are given for information only. In this standard, Annex ZA is normative and Annex A is informative. Annex ZA has been added by CENELEC. Endorsement notice The text of the International Standard IEC1303:1994 was approved by CENELEC as a European Standard without any modification. Contents P
19、age Foreword 2 1 General 3 1.1 Scope and object 3 1.2 Normative references 3 2 Definitions 3 3 Measurement of INSTRUMENT ACCURACY 4 3.1 Primary test method 4 3.2 Secondary test method 4 4 Measurement of SYSTEM LINEARITY 5 4.1 Primary test methods 5 4.2 Secondary test methods 6 5 Measurement of syste
20、m reproducibility 6 5.1 Primary test method 6 5.2 Secondary test method 6 5.3 Evaluation 6 6 Measurement of AIR-DENSITY CHARACTERISTIC 6 6.1 Test method 7 6.2 Evaluation 7 7 Measurement of SAMPLE VOLUME CHARACTERISTIC 7 7.1 Test method 7 7.2 Evaluation 7 8 Measurement of background response 8 8.1 In
21、herent background response Test method 8 8.2 Background response to known radiation field Test method 8 9 Measurement of long-term reproducibility 8 9.1 Method for measurements of long-term reproducibility 8 10 Measurement of shielding performance 8 11 ACCOMPANYING DOCUMENTS and declaration of perfo
22、rmance 8 Annex A (informative) Index of defined terms 10 Annex ZA (normative) Other international publications quoted in this standard with the references of the relevant European publications 11 latest date by which the ENhas to be implemented at national level by publication of an identical nation
23、al standard or by endorsement (dop) 1995-12-01 latest date by which the national standards conflicting with the ENhave to be withdrawn (dow) 1995-12-01EN61303:1995 BSI 10-1999 3 1 General 1.1 Scope and object This International Standard covers RADIONUCLIDE CALIBRATORS of the well type, with a gas-fi
24、lled IONIZATION CHAMBER as used in the practice of NUCLEAR MEDICINE. The object of this standard is to identify the most important characteristics of RADIONUCLIDE CALIBRATORS and lay down associated test methods to enable manufacturers to declare the characteristics of their devices in a standardize
25、d way and facilitate comparisons between devices. 1.2 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 valid. All normative do
26、cuments 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 St
27、andards. IEC 788:1984, Medical radiology Terminology. IEC 1145:1992, Calibration and usage of ionization chamber systems for assay of radionuclides. 2 Definitions For the purposes of this International Standard, the following definitions, as well as the definitions given in IEC 788, apply. Defined t
28、erms are printed in SMALL CAPITAL LETTERS. An index of defined terms is given in Annex AA. 2.1 RADIOACTIVE STANDARD SOURCE General term used to refer to the standard sources listed below. 2.1.1 CERTIFIED RADIOACTIVE STANDARD SOURCE RADIOACTIVE SOURCE that has been calibrated by a laboratory recogniz
29、ed as a countrys national standardizing laboratory for radioactivity measurements and has been so certified by the aforementioned laboratory 2.1.2 TRACEABLE RADIOACTIVE STANDARD SOURCE RADIOACTIVE SOURCE that has been calibrated by comparing it to a CERTIFIED RADIOACTIVE STANDARD SOURCE or to anothe
30、r TRACEABLE RADIOACTIVE STANDARD SOURCE of the same RADIONUCLIDE 2.2 RADIONUCLIDE FACTOR factor, dependent on the RADIONUCLIDE, by which the response of the system must be multiplied in order to obtain the correct ACTIVITY reading of a source which has been placed in the IONIZATION CHAMBER 2.3 OVERA
31、LL UNCERTAINTY quadrature combination of the RANDOM and non-random UNCERTAINTIES at the 68% confidence limits 2.4 SYSTEM LINEARITY function relating the observed and predicted ACTIVITY values when the ACTIVITY of a specified RADIOACTIVE SOURCE is varied 2.5 AIR-DENSITY CHARACTERISTIC two-dimensional
32、 function relating the instrument reading with temperature and pressure 2.6 SAMPLE VOLUME CHARACTERISTIC function relating the instrument reading and the sample volume for a specified container at a specified position in the IONIZATION CHAMBER 2.7 IONIZATION CHAMBER TEST SOURCE RADIOACTIVE SOURCE us
33、ed for the determination ofthe long-term stability of an IONIZATION CHAMBER. The half-life of the source shall be greaterthan five years and the effects of any radioactive contaminants shall be such that the indication by the device over a period of five years would not deviate by more than 0,5% aft
34、er decay correction for the known half-life of the principal RADIONUCLIDE 2.8 IONIZING RADIATION SHIELD component designed to attenuate the passage of IONIZING RADIATION 2.9 RADIOACTIVE IMPURITY RADIONUCLIDES in a RADIOACTIVE SOURCE other than the principal RADIONUCLIDE 2.10 REFERENCE VOLUME volume
35、throughout which the RADIONUCLIDE of a RADIOACTIVE STANDARD SOURCE is distributedEN61303:1995 4 BSI 10-1999 2.11 RADIONUCLIDE CALIBRATOR device for measuring the ACTIVITY of a radioactive sample 2.12 INSTRUMENT ACCURACY ratio of the most probable MEASURED VALUE over the TRUE VALUE 2.13 RANDOM UNCERT
36、AINTY observed standard deviation of a set of repeated measured values 3 Measurement of INSTRUMENT ACCURACY The INSTRUMENT ACCURACY of a reference device shall be determined by the primary method. TheINSTRUMENT ACCURACY of an individual device shall be determined by the secondary method. a) Primary
37、test method: The calibration of the reference device shall be made with standard sources for each RADIONUCLIDE for which the device has specified RADIONUCLIDE FACTORS. If RADIOACTIVE STANDARD SOURCES are not available, a calculation method for RADIONUCLIDE FACTORS may be used by the manufacturer. Ca
38、lculated RADIONUCLIDE FACTORS shall be clearly indicated. b) Secondary test method: The calibration of an individual device shall be made by comparing measurements made with selected RADIONUCLIDES with measurements made with a reference device of the same type and construction which has been tested
39、by the primary method a) above. This method implies a strict quality control program for the reference device. Alternatively, a subset of RADIOACTIVE STANDARD SOURCES can also be used without comparison to the reference device. 3.1 Primary test method 3.1.1 Test procedure This test shall be repeated
40、 for each RADIONUCLIDE and for each type of sample container for which the device has RADIONUCLIDE FACTORS. The RADIONUCLIDE shall be introduced into the measurement position in the device in the form (e.g.liquid) and in the container (e.g. ampoule, vial, syringe) to which the appropriate RADIONUCLI
41、DE FACTOR applies. For each container type, the volume of solution shall be equal to the REFERENCE VOLUME for that container. The ACTIVITY of the RADIOACTIVE STANDARD SOURCE shall be known to an accuracy which is traceable to national standards. The appropriate RADIONUCLIDE FACTOR shall be applied.
42、The ACTIVITY determined by the device shall be recorded, corrected for the effects of background, radioactive decay and radioactive contamination. This measurement shall be repeated until the standard deviation of the mean, S m , of the measured values is less than two-tenths of the uncertainty, S o
43、 , of the ACTIVITY of the RADIOACTIVE STANDARD SOURCE. 3.1.2 Evaluation of INSTRUMENT ACCURACY (primary) The mean measured ACTIVITY value shall be expressed as A m . The RADIOACTIVE STANDARD SOURCE ACTIVITY shallbe expressed as A o . For each RADIONUCLIDE, the INSTRUMENT ACCURACY, A l , is estimated
44、 as A l= A m /A o 100%. The ratios A m /A o , S m /A mandS o /A oshall be stated as percentages. The fractional error in A lis the quadrature combinationof S o /A oand S m /A m , i.e.: 3.2 Secondary test method 3.2.1 Test procedure The reference device shall have been calibrated using the test metho
45、d described in 3.1. The device under test shall be compared with the reference device using a selected subset of RADIONUCLIDES. For each RADIONUCLIDE in the subset, a RADIOACTIVE SOURCE of the RADIONUCLIDE shall be measured in both the device under test and the reference device under identical condi
46、tions. Sufficient measurements shall be taken both with the device under test and the reference device such that the standard deviation of the mean of both measurements is less than two-tenths of the uncertainty, S o(see 3.1.1 and 3.1.2), of the ACTIVITY of the RADIOACTIVE STANDARD SOURCE used for t
47、he measurement of INSTRUMENT ACCURACY of the reference device for that RADIONUCLIDE. These uncertainties shall be stated and the container and volume specified.EN61303:1995 BSI 10-1999 5 The subset of RADIONUCLIDES shall include the following RADIONUCLIDES: 241 Am, 57 Co, 137 Cs and 60 Co. 125 I may
48、 also be used. 3.2.2 Evaluation of INSTRUMENT ACCURACY (secondary) The mean measured ACTIVITY value using the reference device shall be expressed as A y . The mean measured ACTIVITY value using the deviceunder test shall be expressed as A z . The standard deviation of the mean of A yshall be express
49、edasS y . The standard deviation of the mean of A zshall be expressedasS z . For each RADIONUCLIDE, the following ratios shallbestated as percentages: A m /A o , S m /A mandS o /A o(see 3.1.2) and A z /A y , S z /A zand S y /A y . The INSTRUMENT ACCURACY is estimated by: The fractional error is given by: 4 Measurement of SYSTEM LINEARITY The SYSTEM LINEARITY of a reference device shall be determined by the primary test method according to4.1.1 or4.1.2. Where devices are manufactured tothe same specifications as the reference device, the SYSTEM LI
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