1、ISO/ASTM 52628:2013(E)An American National StandardStandard Practice forDosimetry in Radiation Processing1This standard is issued under the fixed designation ISO/ASTM 52628; the number immediately following the designation indicates theyear of original adoption or, in the case of revision, the year
2、of last revision.INTRODUCTIONThe use of ionizing radiation for the treatment of commercial products such as the sterilization ofmedical devices, the reduction of microbial contamination in food or the modification of polymers isreferred to as radiation processing. The types of radiation used may be
3、gamma radiation (typicallyfrom cobalt-60 sources), X-radiation or accelerated electrons.It is necessary to ensure that the specified absorbed dose is applied in each of the radiationprocessing applications. The absorbed dose must be measured, and measurement systems have beendeveloped for this purpo
4、se. Much of the development of these systems rests on the early developmentof dosimetry systems for personnel radiation protection and for medical treatment. However, theabsorbed doses used in radiation processing are generally higher, ranging from 10 Gy up to 100 kGyor more and new dosimetry system
5、s have been developed for measurements of these doses.Note that the terms “dose” and “absorbed dose” are used interchangeably in this standard (see3.1.1).The dose measurements required in radiation processing concern characterization of radiationfacilities in installation qualification (IQ) and oper
6、ational qualification (OQ), measurement of dosedistribution in irradiated products in performance qualification (PQ) and routine monitoring of theirradiation process.The literature is abundant with articles on dosimeters for radiation processing, and guidelines andstandards have been written by seve
7、ral organizations (the International Atomic Energy Agency(IAEA) and the International Commission on Radiation Units and Measurements (ICRU), forexample) for the operation of the dosimetry systems and for their use in the characterization andvalidation of the radiation processing applications. In par
8、ticular, ICRU Report 80 provides informationon the scientific basis and historical development of many of the systems in current use.ASTM Subcommittee E10.01 on Radiation Processing: Dosimetry and Applications was formed in1984 initially with the scope of developing standards for food irradiation, b
9、ut its scope was widenedto include all radiation processing applications. The subcommittee, now Committee E61, has under itsjurisdiction approximately 30 standard practices and standard guides, collectively known as the E61standards on radiation processing. A number of these standards have been publ
10、ished as ISO/ASTMstandards, thereby ensuring a wider international acceptance. These practices and guides describe thedosimetry systems most commonly used in radiation processing, and the dose measurements that arerequired in the validation and routine monitoring of the radiation processes. A curren
11、t list of the E61standards on radiation processing is given in 2.1 and 2.2.The development, validation and routine control of a radiation process comprises a number ofactivities, most of which rely on the ability to measure the delivered dose accurately. It is thereforenecessary that dose is measure
12、d with traceability to national, or international, standards, and theuncertainty is known, including the effect of influence quantities. The E61 standards on radiationprocessing dosimetry serve to fulfill these requirements.The practices describing dosimetry systems have several common attributes, a
13、nd there is a need tohave one general standard that can act as a common reference and that can be used as a basis for theselection of dosimetry systems for defined tasks. ISO/ASTM Practice 52628 serves this purpose. Itoutlines general requirements for the calibration and use of dosimetry systems and
14、 for the estimationof measurement uncertainties. Details relating to each dosimetry system are found in the respectivestandards and each of these refer to ISO/ASTM Practice 52628 for the general requirements. ISO/ASTM International 2013 All rights reserved11. Scope1.1 This practice describes the bas
15、ic requirements that applywhen making absorbed dose measurements in accordance withthe ASTM E61 series of dosimetry standards. In addition, itprovides guidance on the selection of dosimetry systems anddirects the user to other standards that provide specific infor-mation on individual dosimetry syst
16、ems, calibration methods,uncertainty estimation and radiation processing applications.1.2 This practice applies to dosimetry for radiation process-ing applications using electrons or photons (gamma- orX-radiation).1.3 This practice addresses the minimum requirements of ameasurement management system
17、, but does not include generalquality system requirements.1.4 This practice does not address personnel dosimetry ormedical dosimetry.1.5 This practice does not apply to primary standard dosim-etry systems.1.6 This standard does not purport to address all of thesafety concerns, if any, associated wit
18、h its use. It is theresponsibility of the user of this standard to establish appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.2. Reference documents2.1 ASTM Standards:2E170 Terminology Relating to Radiation Measurements andDosimetryE102
19、6 Practice for Using the Fricke Dosimetry SystemE2232 Guide for Selection and Use of Mathematical Meth-ods for Calculating Absorbed Dose in Radiation Process-ing ApplicationsE2303 Guide for Absorbed-Dose Mapping in RadiationProcessing FacilitiesE2304 Practice for Use of a LiF Photo-Fluorescent FilmD
20、osimetry SystemE2381 Guide for Dosimetry In Radiation Processing ofFluidized Beds and Fluid StreamsE2449 Guide for Irradiation of Pre-packaged ProcessedMeat and Poultry Products to Control Pathogens andOther MicroorganismsF1355 Guide for Irradiation of FreshAgricultural Produce asa Phytosanitary Tre
21、atmentF1356 Practice for Irradiation of Fresh and Frozen Red Meatand Poultry to Control Pathogens and Other Microorgan-ismsF1736 Guide for Irradiation of Finfish and Aquatic Inverte-brates Used as Food to Control Pathogens and SpoilageMicroorganismsF1885 Guide for Irradiation of Dried Spices, Herbs,
22、 andVegetable Seasonings to Control Pathogens and OtherMicroorganisms2.2 ISO/ASTM Standards:251205 Practice for Use of a Ceric-Cerous Sulfate DosimetrySystem51261 Practice for Calibration of Routine Dosimetry Sys-tems for Radiation Processing51275 Practice for Use of a Radiochromic Film DosimetrySys
23、tem51276 Practice for Use of a Polymethylmethacrylate Dosim-etry System51310 Practice for Use of a Radiochromic Optical Wave-guide Dosimetry System51401 Practice for Use of a Dichromatic Dosimetry System51431 Practice for Dosimetry in Electron Beam and X-Ray(Bremsstrahlung) Irradiation Facilities fo
24、r Food Process-ing51538 Practice for Use of the Ethanol-Chlorobenzene Do-simetry System51540 Practice for Use of a Radiochromic Liquid DosimetrySystem51607 Practice for Use of the Alanine-EPR Dosimetry Sys-tem51608 Practice for Dosimetry in an X-Ray (Bremsstrahlung)Facility for Radiation Processing5
25、1631 Practice for Use of Calorimetric Dosimetry Systemsfor Electron Beam Dose Measurements and RoutineDosimeter Calibration51649 Practice for Dosimetry in an Electron-Beam Facilityfor Radiation Processing at Energies Between 300 keVand 25 MeV51650 Practice for Use of a Cellulose Triacetate Dosimetry
26、System51702 Practice for Dosimetry in a Gamma Facility forRadiation Processing51707 Guide for Estimating Uncertainties in Dosimetry forRadiation Processing51818 Practice for Dosimetry in an Electron Beam Facilityfor Radiation Processing at Energies Between 80 and 300keV51900 Guide for Dosimetry in R
27、adiation Research on Foodand Agricultural Products51939 Practice for Blood Irradiation Dosimetry51940 Guide for Dosimetry for Sterile Insect ReleasePrograms51956 Practice for Thermoluminescence-Dosimetry (TLD)Systems for Radiation Processing52116 Practice for Dosimetry for a Self-Contained Dry-Stora
28、ge Gamma Irradiator52701 Guide for Performance Characterization of Dosim-eters and Dosimetry Systems for Use in Radiation Pro-cessing1This practice is under the jurisdiction of ASTM Committee E61 on RadiationProcessing and is the direct responsibility of Subcommittee E61.01 on Dosimetry,and is also
29、under the jurisdiction of ISO/TC 85/WG 3.Current edition approved July 20, 2013. Published November 2013. Originallypublished as ASTM E262809. Last previous ASTM edition E2628091. Thepresent International Standard ISO/ASTM 526282013(E) replaces ASTME2628091.2For referenced ASTM and ISO/ASTM standard
30、s, visit the ASTM website,www.astm.org, or contact ASTM Customer Service at serviceastm.org. ForAnnual Book of ASTM Standards volume information, refer to the standardsDocument Summary page on the ASTM website.ISO/ASTM 52628:2013(E)2 ISO/ASTM International 2013 All rights reserved2.3 ISO Standards:3
31、ISO 11137-1 Sterilization of health care products Radia-tion Part 1: Requirements for development, validationand routine control of a sterilization process for medicaldevicesISO 11137-3 Sterilization of health care products Radia-tion Part 3: Guidance on dosimetric aspectsISO 10012 Measurement manag
32、ements systems Require-ments for measurement processes and measuring equip-mentISO/IEC 17025 General requirements for the competence oftesting and calibration laboratories2.4 International Commission on Radiation Units and Mea-surements (ICRU) Reports:4ICRU Report 80 Dosimetry Systems for Use in Rad
33、iationProcessingICRU Report 85a Fundamental Quantities and Units forIonizing Radiation2.5 Joint Committee for Guides in Metrology (JCGM)Reports:JCGM 100:2008, GUM , 1995, with minor corrections,Evaluation of measurement data Guide to the Expres-sion of Uncertainty in Measurement5JCGM 100:2008, VIM ,
34、 International vocabulary of metrol-ogy basis and general concepts and associated terms63. Terminology3.1 Definitions:3.1.1 absorbed dose (D)quotient of d by dm, where d isthe mean energy imparted by ionizing radiation to matter ofmass dm, thusD 5 ddmICRU 85a3.1.1.1 DiscussionThe SI unit of absorbed
35、 dose is the gray(Gy), where 1 gray is equivalent to the absorption of 1 joule perkilogram of the specified material (1 Gy = 1 J/kg).3.1.2 accredited dosimetry calibration laboratorydosimetry laboratory with formal recognition by an accreditingorganization that the dosimetry laboratory is competent
36、tocarry out specific activities which lead to the calibration orcalibration verification of dosimetry systems in accordancewith documented requirements of the accrediting organization.3.1.3 calibrationset of operations that establish, underspecified conditions, the relationship between values of qua
37、n-tities indicated by a measuring instrument or measuringsystem, or values represented by a material measure or areference material, and the corresponding values realized bystandards.3.1.4 dosimeterdevice that, when irradiated, exhibits aquantifiable change that can be related to absorbed dose in ag
38、iven material using appropriate measurement instruments andprocedures.3.1.5 dosimeter/dosimetry system characterizationdetermination of performance characteristics, such as doserange, reproducibility and the effect of influence quantities, fora dosimeter/dosimetry system under defined test condition
39、s.3.1.6 dosimeter response reproducible, quantifiable effectproduced in the dosimeter by ionizing radiation.3.1.6.1 DiscussionThe dosimeter response value, ob-tained from one or more measurements, is used in the estima-tion of the derived absorbed dose. The response value may beobtained from such me
40、asurements as optical absorbance,thickness, mass peak-to-peak distance in EPR spectra, orelectropotential between solutions.3.1.7 dosimetrymeasurement of absorbed dose by the useof a dosimetry system.3.1.8 dosimetry systemsystem used for measuring ab-sorbed dose, consisting of dosimeters, measuremen
41、t instru-ments and their associated reference standards, and proceduresfor the systems use.3.1.9 influence quantityquantity that, in a directmeasurement, does not affect the quantity that is actuallymeasured, but affects the relation between the indication andthe measurement result. VIM3.1.10 measur
42、ement management systemset of interre-lated or interacting elements necessary to achieve metrologicalconfirmation and continual control of measurement processes.3.1.11 primary standard dosimetry system dosimetry sys-tem that is designated or widely acknowledged as having thehighest metrological qual
43、ities and whose value is acceptedwithout reference to other standards of the same quantity.3.1.12 radiation processingintentional irradiation of prod-ucts or materials to preserve, modify or improve their charac-teristics.3.1.13 reference standard dosimetry systemdosimetrysystem, generally having th
44、e highest metrological qualityavailable at a given location or in a given organization, fromwhich measurements made there are derived.3.1.14 reference standard radiation fieldcalibrated radia-tion field, generally having the highest metrological qualityavailable at a given location or in a given org
45、anization, fromwhich measurements made there are derived.3.1.15 response functionmathematical representation ofthe relationship between dosimeter response and absorbed dosefor a given dosimetry system.3.1.16 routine dosimetry systemdosimetry system cali-brated against a reference standard dosimetry
46、system and usedfor routine absorbed dose measurements, including dose map-ping and process monitoring.3.1.17 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 ch
47、ain of comparisons all having stated uncertain-ties.3Available from International Organization for Standardization (ISO), 1, ch. dela Voie-Creuse, Case postale 56, CH-1211, Geneva 20, Switzerland, http:/www.iso.ch.4Available from the International Commission on Radiation Units andMeasurements, 7910
48、Woodmont Ave, Suite 800, Bethesda, MD 20815, USA.5Document 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).6Document produced by Working Group 2 of the Joint Committee for Guides inMetrology (JCG
49、M/WG 2). Available free of charge at the BIPM website (http:/www.bipm.org).ISO/ASTM 52628:2013(E)3 ISO/ASTM International 2013 All rights reserved3.1.18 transfer standard dosimetry systemdosimetry sys-tem used as an intermediary to calibrate other dosimetrysystems.3.1.19 type I dosimeterdosimeter of high metrologicalquality, the response of which is affected by individual influ-ence quantities in a well-defined way that can be expressed interms of independent correction factors.3.1.19.1 DiscussionSee Section 6 for examples and fu
