ANSI ISO ASTM 51940-2013 Standard Guide for Dosimetry for Sterile Insect Release Programs.pdf

1、ISO/ASTM 51940:2013(E)Standard Guide forDosimetry for Sterile Insect Release Programs1This standard is issued under the fixed designation ISO/ASTM 51940; the number immediately following the designation indicates theyear of original adoption or, in the case of revision, the year of last revision.1.

2、Scope1.1 This guide outlines dosimetric procedures to be fol-lowed for the radiation-induced reproductive sterilization oflive insects for use in pest management programs. The primaryuse of such insects is in the Sterile Insect Technique, wherelarge numbers of reproductively sterile insects are rele

3、ased intothe field to mate with and thus control pest populations of thesame species. A secondary use of sterile insects is as benignhosts for rearing insect parasitoids. The procedures outlined inthis guide will help ensure that insects processed with ionizingradiation from gamma, electron, or X-ra

4、y sources receiveabsorbed doses within a predetermined range. Information oneffective dose ranges for specific applications of insectsterilization, or on methodology for determining effective doseranges, is not within the scope of this guide.NOTE 1Dosimetry is only one component of a total quality a

5、ssuranceprogram to ensure that irradiated insects are adequately sterilized and fullycompetitive or otherwise suitable for their intended purpose.1.2 This guide provides information on dosimetry for theirradiation of insects for these types of irradiators: self-contained dry-storage137Cs or60Co irra

6、diators, self-containedlow-energy X-ray irradiators (maximum processing energiesfrom 150 to 300 keV), large-scale gamma irradiators, andelectron accelerators (electron and X-ray modes).NOTE 2Additional, detailed information on dosimetric procedures tobe followed in installation qualification, operat

7、ional qualification, perfor-mance qualification, and routine product processing can be found inISO/ASTM Practices 51608 (X-ray bremsstrahlung facilities processingat energies over 300 keV), 51649 (electron beam facilities), 51702(large-scale gamma facilities), and 52116 (self-contained dry-storagega

8、mma facilities), and in Ref (1)2(self-contained X-ray facilities).1.3 The absorbed dose for insect sterilization is typicallywithin the range of 20 to 600 Gy.1.4 This guide refers, throughout the text, specifically toreproductive sterilization of insects. It is equally applicable toradiation sterili

9、zation of invertebrates from other taxa (forexample,Acarina, Gastropoda) and to irradiation of live insectsor other invertebrates for other purposes (for example, induc-ing mutations), provided the absorbed dose is within the rangespecified in 1.3.1.5 This guide also covers the use of radiation-sens

10、itiveindicators for the visual and qualitative indication that theinsects have been irradiated.1.6 This document is one of a set of standards that providesrecommendations for properly implementing and utilizingdosimetry in radiation processing and describes a means ofachieving compliance with the re

11、quirements ofASTM PracticeE2628. It is intended to be read in conjunction with ASTME2628.1.7 This standard does not purport to address all of thesafety concerns, if any, associated with its use. It is theresponsibility of the user of this standard to establish appro-priate safety and health practice

12、s and determine the applica-bility of regulatory limitations prior to use.2. Referenced documents2.1 ASTM Standards:3E170 Terminology Relating to Radiation Measurements andDosimetryE2303 Guide for Absorbed-Dose Mapping in RadiationProcessing FacilitiesE2628 Practice for Dosimetry in Radiation Proces

13、singE2701 Guide for Performance Characterization of Dosim-eters and Dosimetry Systems for Use in Radiation Pro-cessing2.2 ISO/ASTM Standards:351261 Practice for Calibration of Routine Dosimetry Sys-tems for Radiation Processing51275 Practice for Use of a Radiochromic Film DosimetrySystem51310 Practi

14、ce for Use of a Radiochromic Optical Wave-guide Dosimetry System51539 Guide for the Use of Radiation-Sensitive Indicators51607 Practice for Use of an Alanine-EPR Dosimetry Sys-tem1This guide is under the jurisdiction of ASTM Committee E61 on RadiationProcessing and is the direct responsibility of Su

15、bcommittee E61.04 on SpecialtyApplication, and is also under the jurisdiction of ISO/TC 85/WG 3.Current edition approved Dec. 26, 2012. Published April 2013. Originallypublished as ASTM E 194098. Last previous ASTM edition E 194098. Thepresent International Standard ISO/ASTM 51940:2013(E) replaces A

16、STM E194098 and is a major revision of the last previous edition ISO/ASTM51940:2004(E).2The boldface numbers in parentheses refer to the bibliography at the end of thisstandard.3For referenced ASTM and ISO/ASTM standards, visit the ASTM website,www.astm.org, or contact ASTM Customer Service at servi

17、ceastm.org. ForAnnual Book of ASTM Standards volume information, refer to the standardsDocument Summary page on the ASTM website. ISO/ASTM International 2017 All rights reservedThis international standard was developed in accordance with internationally recognized principles on standardization estab

18、lished in the Decision on Principles for theDevelopment of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.151608 Practice for Dosimetry in an X-Ray (Bremsstrahlung)Facility for Radiation Processing51649 Practice

19、for Dosimetry in an Electron Beam Facilityfor Radiation Processing at Energies Between 300 keVand 25 MeV51702 Practice for Dosimetry in a Gamma Facility forRadiation Processing51707 Guide for Estimating Uncertainties in Dosimetry forRadiation Processing51956 Practice for Use of Thermoluminescence-Do

20、simetry(TLD) Systems for Radiation Processing52116 Practice for Dosimetry for a Self-Contained Dry-Storage Gamma-Ray Irradiator2.3 International Commission on Radiation Units and Mea-surements (ICRU) Reports:4ICRU 85a Fundamental Units and Quantities for IonizingRadiation2.4 ISO Standards:5ISO/IEC 1

21、7025 General Requirements for the Competenceof Testing and Calibration Laboratories2.5 Joint Committee for Guides in Metrology (JCGM)Reports:JCGM 100:2008, GUM, with minor corrections, Evaluationof measurement data Guide to the Expression ofUncertainty in Measurement6JCGM 100:2008, VIM International

22、 vocabulary of metrol-ogy Basis and general concepts and associated terms73. Terminology3.1 Definitions:3.1.1 absorbed dose (D)quantity of ionizing radiationenergy imparted per unit mass of a specified material. The SIunit of absorbed dose is the gray (Gy), where 1 gray isequivalent to the absorptio

23、n of 1 joule per kilogram of thespecified material (1 Gy = 1 J/kg). The mathematical relation-ship is the quotient of d by dm, where d is the meanincremental energy imparted by ionizing radiation to matter ofincremental mass dm (see ICRU 85a).D 5 d/dm3.1.1.1 DiscussionThe discontinued unit for absor

24、beddose is the rad (1 rad = 100 erg/g = 0.01 Gy). Absorbed doseis sometimes referred to simply as dose.3.1.2 absorbed-dose mappingmeasurement of absorbed-dose within an irradiated product to produce a one-, two- orthree-dimensional distribution of absorbed dose, thus renderinga map of absorbed-dose

25、values.3.1.3 absorbed-dose rate, Dabsorbed dose in a materialper incremental time interval, that is, the quotient of dD by dt.Also see ASTM E170. The SI unit is Gys1D5 dD/dt3.1.3.1 DiscussionThe absorbed-dose rate can be speci-fied in terms of its average value over long-time intervals, forexample i

26、n units of Gymin1or Gyh13.1.4 approved laboratorylaboratory that is a recognizednational metrology institute, or has been formally accredited toISO/IEC 17025, or has a quality system consistent with therequirements of ISO/IEC 17025.3.1.4.1 DiscussionA recognized national metrology insti-tute or othe

27、r calibration laboratory accredited to ISO/IEC17025 should be used in order to ensure traceability to anational or international standard. A calibration certificateprovided by a laboratory not having formal recognition oraccreditation will not necessarily be proof of traceability to anational or int

28、ernational standard.3.1.5 calibration VIM, 6.11set of operations thatestablish, under specified conditions, the relationship betweenvalues of quantities indicated by a measuring instrument ormeasuring system, or values represented by a material measureor a reference material, and the corresponding v

29、alues realizedby standards.3.1.5.1 DiscussionCalibration conditions include environ-mental and irradiation conditions present during irradiation,storage and measurement of the dosimeters that are used for thegeneration of a calibration curve. To achieve stable environ-mental conditions, it may be ne

30、cessary to condition thedosimeters before performing the calibration procedure.3.1.6 dose uniformity ratioratio of maximum to minimumabsorbed dose within the irradiated product.3.1.6.1 DiscussionThe concept is also referred to as themax/min dose ratio.3.1.7 dosimeterdevice that, when irradiated, exh

31、ibits aquantifiable change that can be related to absorbed dose in agiven material using appropriate measurement instruments andprocedures.3.1.8 dosimeter batchquantity of dosimeters made from aspecific mass of material with uniform composition, fabricatedin a single production run under controlled,

32、 consistent condi-tions and having a unique identification code.3.1.9 dosimeter setone or more dosimeters used to mea-sure the absorbed dose at a location and whose average readingis used to determine absorbed dose at that location.3.1.10 dosimetry systemsystem used for measuring ab-sorbed dose, con

33、sisting of dosimeters, measurement instru-ments and their associated reference standards, and proceduresfor the systems use.3.1.11 influence quantityquantity that is not the mea-surand but that affects the result of the measurement.3.1.11.1 DiscussionIn radiation processing dosimetry, thisterm inclu

34、des temperature, relative humidity, time intervals,light, radiation energy, absorbed-dose rate, and other factorsthat might affect dosimeter response, as well as quantitiesassociated with the measurement instrument.3.1.12 in-situ/in-plant calibrationcalibration where thedosimeter irradiation is perf

35、ormed in the place of use of theroutine dosimeters.4Available from the International Commission on Radiation Units andMeasurements, 7910 Woodmont Ave., Suite 800, Bethesda, MD 20814, USA.5Available from International Organization for Standardization (ISO), 1 Rue deVaremb, Case Postale 56, CH-1211, G

36、eneva 20, Switzerland.6Document produced by Working Group 1 of the Joint Committee for Guides inMetrology (JCGM/WG 1). Available free of charge at the BIPM website (http:/www.bipm.org).7Document produced by Working Group 2 of the Joint Committee for Guides inMetrology (JCGM/WG 2). Available free of

37、charge at the BIPM website (http:/www.bipm.org).ISO/ASTM 51940:2013(E)2 ISO/ASTM International 2017 All rights reserved 3.1.12.1 DiscussionIn-situ/in-plant calibration of dosim-etry systems refers to irradiation of dosimeters along withreference or transfer dosimeters, under operating conditionsthat

38、 are representative of the routine processing environment,for the purpose of developing a calibration curve for the routinedosimetry systems.3.1.13 installation qualificationprocess of obtaining anddocumenting evidence that equipment has been provided andinstalled in accordance with its specificatio

39、n.3.1.14 irradiation containerholder in which product isplaced during the irradiation process.3.1.14.1 DiscussionFor insect irradiation, the configura-tion of irradiation containers varies widely with such factors astype and energy of radiation, irradiator design, insect species,insect stage being i

40、rradiated, and other process specifications(for example, some insects are irradiated in reduced-oxygenatmospheres, requiring air-tight containers). Irradiation con-tainers for insects range from single-use items such as papercylinders or plastic bags to reusable canisters of stainless steelor other

41、durable material. When canisters are used, insects areoften held secondarily within the canister in a plastic bag orother disposable container.3.1.15 irradiator turntabledevice used to rotate thesample during the irradiation process so as to improve doseuniformity.3.1.15.1 DiscussionAn irradiator tu

42、rntable is often re-ferred to as a turntable. Some irradiator geometries, forexample, with an annular array of radiation sources surround-ing the product, may not need a turntable.3.1.16 operational qualification (OQ)process of obtainingand documenting evidence that installed equipment operateswithi

43、n predetermined limits when used in accordance with itsoperational procedures.3.1.17 performance qualification (PQ)process of obtain-ing and documenting evidence that the equipment, as installedand operated in accordance with operation procedures, consis-tently performs in accordance with predetermi

44、ned criteria andthereby yields product meeting its specification.3.1.18 radiation-sensitive indicatormaterial such as acoated or impregnated adhesive-backed substrate, ink, coatingor other materials which may be affixed to or printed on theproduct or irradiation container and which undergoes a visua

45、lchange when exposed to ionizing radiation (see ISO/ASTMGuide 51539).3.1.18.1 DiscussionRadiation-sensitive indicators are of-ten referred to as “indicators.” Indicators may be used to showthat products have been exposed to ionizing radiation. Theycan be used to provide a visual and qualitative indi

46、cation ofradiation exposure and can be used to distinguish betweenirradiated and unirradiated samples. Indicators cannot be usedas a substitute for proper dosimetry.3.1.19 reference standard dosimetry systemdosimetrysystem, generally having the highest metrological qualityavailable at a given locati

47、on or in a given organization, fromwhich measurements made there are derived.3.1.20 routine dosimetry systemdosimetry system cali-brated against a reference standard dosimetry system and usedfor routine absorbed-dose measurements, including dose map-ping and process monitoring.3.1.21 simulated produ

48、ctmass of material with absorptionand scattering properties similar to those of the product,material or substance to be irradiated.3.1.21.1 DiscussionSimulated product is used during irra-diator characterization as a substitute for the actual product,material, or substance to be irradiated. When use

49、d in routineproduction runs in order to compensate for the absence ofproduct, it is sometimes referred to as compensating dummy.When used for absorbed-dose mapping, simulated product issometimes referred to as a phantom material.3.1.22 traceabilityproperty of the result of a measurementor the value of a standard whereby it can be related to statedreferences, usually national or international standards, throughan unbroken chain of comparisons all