1、ANSI N42.13-2004(Reaffirmation of ANSI N42.13-1986)American National StandardCalibration and Usage of“Dose Calibrator” Ionization Chambersfor the Assay of RadionuclidesNational Committee on Radiation Instrumentation, N42Accredited by the American National Standards InstituteSecretariatInstitute of E
2、lectrical and Electronics Engineers, Inc.Approved 2 December 2004American National Standards InstitutePublished byInstitute of Electrical and Electronics Engineers, Inc.3 Park Avenue, New York, NY 10016-5997 USA Copyright 1986 byThe institute of Electrical and Electronics Engineers, inc.No Part of t
3、his publication may be reproduced in any form, in an electronic retrieval system or otherwise, without the priorwritten permission of the publisher.iiAmerican National StandardAn American National Standard implies a consensus of those substantially concerned with its scope and provisions.An American
4、 National Standard is intended as a guide to aid the manufacturer, the consumer, and the general public.The existence of an American National Standard does not in any respect preclude anyone, whether he has approved thestandard or not, from manufacturing, marketing, purchasing, or using products, pr
5、ocesses, or procedures notconforming to the standard. American National Standards are subject to periodic review and users are cautioned toobtain the latest editions.CAUTION NOTICE:This American National Standard may be revised or withdrawn at any time. The procedures ofthe American National Standar
6、ds Institute require that action be taken to reafrm, revise, or withdraw this standard nolater than ve years from the date of publication. Purchasers of American National Standards may receive currentinformation on all standards by calling or writing the American National Standards Institute.iiiFore
7、word(This Foreword is not a part of ANSI N42.13-1986, American National Standard Calibration and Usage of Dose CalibratorIonization Chambers for the Assay of Radionuclides.)This revised standard is the responsibility of Accredited Standards Committee N42 on Radiation Instrumentation.Committee N42 de
8、legated the development of the standard to its Subcommittee N42.2. Drafts were reviewed by themembers of Committee N42, Subcommittee N42.2, and by other interested parties. The comments received wereutilized in producing the standard as nally approved and issued. The revised standard was approved by
9、 CommitteeN42 letter ballot of December 30, 1984, with minor modications as submitted to the Committee N42 membership onAugust 29, 1984.At the time it approved this revised standard, the Accredited Standards Committee N42 on Radiation Instrumentationhad the following membership:Louis Costrell, Chair
10、 David C. Cook, Secretary American Chemical Society.(Vacant)American Conference of Governmental Industrial HygienistsJesse LiebermanAmerican Industrial Hygiene Association .(Vacant)American Nuclear Society .Frank ManningAmerican Society of Mechanical Engineers(Vacant)American Society of Safety Engin
11、eers (Vacant)Atomic Industrial Forum(Vacant)Health Physics Society. J. B. Horner KuperJack M. Selby (Alt)Institute of Electrical and Electronics Engineers .Louis CostrellDavid C. Cook (Alt)J. Forster (Alt)A. J. Spurgin (Alt)Instrument Society of America M. T. SlindJ. E. Kaveckis (Alt)Lawrence Berkel
12、ey LaboratoryLee J. WagnerOak Ridge National Laboratory.Frank ManningD. J. Knowles (Alt)Scientic Apparatus Makers Association.(Vacant)UCLA Center for the Health Sciences.James E. McLaughlinUS Civil Defense Preparedness Agency Carl R. Siebentritt, JrUS Department of the Army, Materiel Command .Basil
13、MarkowUS Department of Commerce, National Bureau of Standards Louis CostrellUS Department of Energy Pollutant Characterization and Safety Research Division Gerald GoldsteinUS Nuclear Regulatory Commission.Edward C. Wenzinger, SrivThe membership of Subcommittee N42.2 was as follows:F. X. Masse(Chairm
14、an)J. M. Robin Hutchinson, Secretary Ron AlthardtKarl AmlauerJohn H. BuchananRobert BurnsR. F. ColeyBert M. CourseyRod DaytonRoger FerrisJ. FloeckherR. J. GehrkeJames GibbsAllen GoldsteinDonald HamiltonDale HoppesDonald HorrocksA. JarvisDonald S. KearnsStephen M. KimY. KobayashiWilliam MacIntyreW. B
15、. MannGerald Martin, JrDavid V. MaudsleyPaul MurphyRalph NuelleM. J. OestmannJ. RingCarl W. SeidelS. S. YanivvThe following persons were on the balloting committee that approved this document for submission to the AccreditedStandards Committee N42:Joseph G. BellianO. W. Bilharz, JrLouis CostrellDavi
16、d C. CookJohn M. Gallagher, JrGerald GoldsteinJ. B. Horner KuperJesse LiebermanFrank ManningBasil MarkowJames E. McLaughlinRichard F. SheaCarl R. Siebentritt, JrM. T. SlindE. J. VallarioLee J. WagnerEdward C. Wenzinger, SrviCLAUSE PAGE1. Introduction.12. Scope.12.1 12.2 13. Definitions and Reference
17、s .23.1 Definitions 23.2 References 24. Procedure 24.1 General . 24.2 Initial Calibrations 24.3 Standard Sources 34.4 Assay 34.5 Performance Testing 44.6 Accuracy and Reproducibility . 45. Sources of Error 56. Precautions 56.1 Assay of a Radionuclide for Which No Standard or Calibration Setting Is A
18、vailable 56.2 Nonlinearity Effect. 56.3 Radionuclidic Impurities 66.4 Beta-Particle Emitters 66.5 Low-Energy-Photon Emitters 66.6 Dissolved Gaseous Radionuclides . 66.7 Plate-Out of Radionuclides 76.8 Simulated Sources 7Copyright 1986 IEEE All Rights Reserved1American National StandardCalibration an
19、d Usage ofDose Calibrator IonizationChambers for the Assay of Radionuclides1. IntroductionThe wide range of calibrator-type instruments currently being used primarily for radionuclide assay in nuclearmedicine indicates the need for a standard for uniformity in measurement and test techniques. Such d
20、evices arecomposite systems consisting of an ionization chamber integrally coupled to appropriate electronic circuitry thatconverts the ionization current to a readout in units of activity. The principles of operation of the ionization chamberare well summarized in the NCRP Report No 58 11and will n
21、ot be repeated here. Wide activity range and stabilityare useful characteristics of ionization chambers in this application. The advantages of this type of system forradionuclide assay include ease of use and interpretation.2. Scope2.1 This standard covers the technique for the quantication of the a
22、ctivity of identied radionuclides using any of avariety of ionization chambers currently available for this purpose. Application of the standard is limited toinstruments that incorporate well-type ionization chambers as detectors.2.2 This standard provides a method for obtaining measurements that ar
23、e accurate to within 10% and reproducible towithin 5% usually for sources of more than 100 mCi (3.7 106Bq). The standard is also intended to assurecontinuing performance of the apparatus within these specications. For purposes of this standard, accuracy andreproducibility are described in 4.6.1The n
24、umbers in brackets correspond to the references in 3.2.2Copyright 1986 IEEE All Rights ReservedIEEE Std N42.13-1986 AMERICAN NATIONAL STANDARD CALIBRATION AND USAGE OF 3. Definitions and References3.1 Definitionsaccuracy: Accuracy, usually described in terms of overall uncertainty, is the estimate o
25、f the overall possible deviationfrom the stated value. As used in this standard, the overall uncertainty is a total of the estimated error itemized inSection 5. plus the random uncertainty of the measurement.calibration: The process of determining the numerical relationship, within an overall stated
26、 uncertainty, between theobserved output of a measurement system and the value, based on standard sources, of the physical quantity beingmeasured.shall: Indicates a recommendation that is necessary or essential to meet requirements of this standard.should: Indicates an advisory recommendation that i
27、s to be applied when practicable.simulated sources: Simulated sources usually contain long-lived radionuclides, alone or in combination, that arechosen to simulate, in terms of photon or particle emission, a short-lived radionuclide of interest.standard sources: A general term used to refer to the s
28、tandard sources listed below:1)national radioactivity standard source.A calibrated radioactive source prepared and distributed as a standardreference material by the US National Bureau of Standards.2)certied radioactivity standard source.A calibrated radioactive source, with stated accuracy, whoseca
29、libration is certied by the source supplier as traceable to the National Radioactivity MeasurementsSystem 2.3.2 References1 National Council on Radiation Protection and Measurements. A Handbook of Radioactivity MeasurementsProcedures. NCRP Report no 58, 2nd ed, Washington, DC, 1985.2 CAVALLO, L. M.,
30、 COURSEY, B. M., GARFINKEL, S. B., HUTCHINSON, J. M. R., and MANN, W. B. Need forRadioactivity Standards and Measurements in Different Fields. Nuclear Instruments and Methods, vol 112, 1973,pp 518.4. Procedure4.1 GeneralInstruments shall be installed and operated in accordance with the manufacturers
31、 instructions.4.2 Initial CalibrationsInstruments shall be calibrated with identied radionuclide sources of known activity and established purity. Asdescribed in 4.4, calibrations should be performed with standard sources of each radionuclide of interest, if at allfeasible.4.2.1 GeometryThe dependen
32、ce of the assay on the geometrical conguration and composition of the source container shall be takeninto consideration in the calibration procedure. Most manufacturers have adopted a calibration geometry using anominal 30 mL multidose vial with 20 mL of contents, and standard sources of this descri
33、ption are generally available(usually in plastic containers).Copyright 1986 IEEE All Rights Reserved3“DOSE CALIBRATOR“ IONIZATION CHAMBERS FOR THE ASSAY OF RADIONUCLIDES IEEE Std N42.13-1986Positioning of such vials in the detector well must be reproducible for such systems. Correction factors or ne
34、wcalibrations shall be obtained for assaying radionuclides in containers of different sizes or shapes. Such correctionfactors may be determined by measurement of the same quantity of a given radionuclide in containers of differentgeometry, with any necessary adjustment to the volume using the approp
35、riate carrier solution. Correction factorssupplied by the manufacturer should also be checked as described above.4.2.2 Activity RangesCalibration of the equipment should cover as completely as practicable the activity ranges for which it will be used,particularly those ranges of activity of radionuc
36、lides to be administered to patients. Whenever measurements in thelow microcurie range are attempted, background corrections are imperative.4.2.3 Energy RangeCalibration shall be performed over the photon energy range of proposed application.4.2.4 Accuracy and ReproducibilityThe calibration procedur
37、es should be such that the accuracy and reproducibility of measurements made with thecalibrated instrument will be within the limits stated in 4.6.4.3 Standard SourcesSuitable standard sources characterized as to radionuclide purity and activity shall be used for routine calibration of theequipment.
38、 Correction for decay of a standard source since the time of standardization should be applied if more than2% of a half life has expired.4.3.1 GeometryIdeally, to avoid the necessity for corrections, the geometry of the standard source should be identical to the geometryof the source to be assayed.
39、Source manufacturers now offer standard sources that conform to the calibration geometrydescribed in 4.2.1.4.3.2 Activity RangeA suitable range of activities should be available for use. The selection of standard sources should take intoconsideration the accuracy required over the ranges of activity
40、 of radionuclides to be administered to patients.4.3.3 Energy RangeA suitable range of photon emission energies should be covered in the selection of standard sources. 125I (0.03 MeV)(0.05 10-13J), 57Co (0.12 MeV) (0.19 10-13J), 133Ba (0.36 Mev) (0.58 10-13J), and 137Cs (0.66 MeV) (1.06 10-13J) are
41、representative of radionuclide sources of photons in the energy range typically used in nuclear medicine.4.4 AssayRadionuclides shall be assayed in a properly calibrated instrument using an appropriate precalibrated radionuclidesetting or plug-in module. The activity of a radionuclide for which no s
42、etting or module is available may also beaccurately measured relative to a standard source of the same radionuclide using any setting or module that yields ahigh enough reading to give reproducible results.4Copyright 1986 IEEE All Rights ReservedIEEE Std N42.13-1986 AMERICAN NATIONAL STANDARD CALIBR
43、ATION AND USAGE OF 4.5 Performance TestingRegular testing of the instrument performance is required to assure the accuracy of assays.4.5.1 Reference Source ChecksCalibration checks using a long-lived reference source shall be performed and logged on each work shift during whichthe instrument is used
44、. This check shall be repeated whenever sample readings are not within 10% of their anticipatedassay. It is required that at least two such reference sources be available for example, 100200 mCi (3.70-7.40 106Bq) of 137Cs, and 15 mCi (40180 106Bq) of 57Co with appropriate correction for decay. These
45、 sources could bealternated each day of use to test the instruments performance over a range of photon energies and source activities.4.5.2 Linearity CheckA convenient high-activity-range linearity check is outlined in 6.2. This check shall be performed and logged atintervals not to exceed 3 months.
46、4.5.3 Background ChecksBackground checks shall be performed and logged daily, at least at the radionuclide settings to be used that day. Thesechecks will serve to detect either contamination or faulty operation.4.5.4 Response Check at Various SettingsMeasurements of a long-lived reference source at
47、settings for several radionuclides of interest will yield readings thatshould be reproducible over a period of time. Such readings serve as suitable checks on the stability of the instrumentfor measurements of radionuclides for which calibrations have been established, but for which standard sources
48、 are notalways available for use. This check shall be performed and logged daily utilizing such sources as those listed in 4.5.1to check the response of the instrument for the calibration of radionuclides that the user anticipates assaying on thatday.4.5.5 Frequency of CalibrationAnnually, following
49、 repair, and following extended periods of nonutilization, calibrations using standard sources of atleast two radionuclides covering the energy and activity ranges of interest shall be performed and logged.4.5.6 Supplementary CalibrationsAs standard sources of additional radionuclides of interest become available, the instrument should be calibratedagainst such standard sources, particularly if such radionuclides are intended for human administration.4.6 Accuracy and ReproducibilityMinimum requirements, in terms of accuracy and reproducib
