ASTM E2628-2009 Standard Practice for Dosimetry for Radiation Processing.pdf

1、Designation: E 2628 09An American National StandardStandard Practice forDosimetry for Radiation Processing1This standard is issued under the fixed designation E 2628; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last

2、 revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.INTRODUCTIONThe use of ionizing radiation for the treatment of commercial products such as the sterilization ofmedical devices, the re

3、duction of microbial contamination in food or the modification of polymers isreferred to as radiation processing. The types of radiation used may be gamma radiation (typicallyfrom cobalt-60 sources), X-radiation or accelerated electrons.It is necessary to ensure that the specified absorbed dose is a

4、pplied in each of the radiationprocessing applications. The absorbed dose must be measured, and measurement systems have beendeveloped for this purpose. Much of the development of these systems rests on the early developmentof dosimetry systems for personnel radiation protection and for medical trea

5、tment. However, theabsorbed doses used in radiation processing are generally higher, ranging from 10 Gy up to 100 kGyor more and new dosimetry systems have been developed for measurements of these doses.Note that the terms “dose” and “absorbed dose” are used interchangeably in this standard (see3.1.

6、1).The dose measurements required in radiation processing concern characterization of radiationfacilities in installation qualification (IQ) and operational qualification (OQ), measurement of dosedistribution in irradiated products in performance qualification (PQ) and routine monitoring of theirrad

7、iation process.The literature is abundant with articles on dosimeters for radiation processing, and guidelines andstandards have been written by several organizations (the International Atomic Energy Agency(IAEA) and the International Commission on Radiation Units and Measurements (ICRU), forexample

8、) for the operation of the dosimetry systems and for their use in the characterization andvalidation of the radiation processing applications. In particular, ICRU Report 80 provides informationon the scientific basis and historical development of many of the systems in current use.ASTM Subcommittee

9、E10.01 on Radiation Processing: Dosimetry and Applications was formed in1984 initially with the scope of developing standards for food irradiation, but its scope was widenedto include all radiation processing applications. The subcommittee has under its jurisdictionapproximately 30 standard practice

10、s and standard guides, collectively known as the E10.01 standardson radiation processing. A number of these standards have been published as ISO/ASTM standards,thereby ensuring a wider international acceptance. These practices and guides describe the dosimetrysystems most commonly used in radiation

11、processing, and the dose measurements that are required inthe validation and routine monitoring of the radiation processes. A current list of the E10.01 standardson radiation processing is given in 2.1 and 2.2.The development, validation and routine control of a radiation process comprises a number

12、ofactivities, most of which rely on the ability to measure the delivered dose accurately. It is thereforenecessary that dose is measured with traceability to national, or international, standards, and theuncertainty is known, including the effect of influence quantities. The E10.01 standards on radi

13、ationprocessing dosimetry serve to fulfill these requirements.The practices describing dosimetry systems have several common attributes, and 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 define

14、d tasks. Practice E 2628 serves this purpose. It outlinesgeneral requirements for the calibration and use of dosimetry systems and for the estimation ofmeasurement uncertainties. Details relating to each dosimetry system are found in the respectivestandards and each of these refer to Practice E 2628

15、 for the general requirements.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.1. Scope1.1 This practice describes the basic requirements that applywhen making absorbed dose measurements in accordance withthe ASTM E10.01 series of dos

16、imetry 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 systems, calibration methods,uncertainty estimation and radiation processing applications.1.2 This practice appli

17、es 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, but does not include generalquality system requirements.1.4 This practice does not address personnel dosime

18、try 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 with its use. It is theresponsibility of the user of this standard to establish appro-priate safety and health p

19、ractices and determine the applica-bility of regulatory limitations prior to use.2. Referenced Documents2.1 ASTM Standards:2E 170 Terminology Relating to Radiation Measurementsand DosimetryE 1026 Practice for Using the Fricke Reference-StandardDosimetry SystemE 2232 Guide for Selection and Use of Ma

20、thematical Meth-ods for CalculatingAbsorbed Dose in Radiation ProcessingApplicationsE 2303 Guide for Absorbed-Dose Mapping in RadiationProcessing FacilitiesE 2304 Practice for Use of a LiF Photo-Fluorescent FilmDosimetry SystemE 2381 Guide for Dosimetry In Radiation Processing ofFluidized Beds and F

21、luid StreamsE 2449 Guide for Irradiation of Pre-packaged ProcessedMeat and Poultry Products to Control Pathogens and OtherMicroorganismsE 2701 Guide for Performance Charcterization of Dosim-eters and Dosimetry Systems for Use in Radiation Process-ingF 1355 Guide for Irradiation of Fresh Agricultural

22、 Produceas a Phytosanitary TreatmentF 1356 Practice for Irradiation of Fresh and Frozen RedMeat and Poultry to Control Pathogens and Other Micro-organismsF 1736 Guide for Irradiation of Finfish and Aquatic Inver-tebrates Used as Food to Control Pathogens and SpoilageMicroorganismsF 1885 Guide for Ir

23、radiation of Dried Spices, Herbs, andVegetable Seasonings to Control Pathogens and OtherMicroorganisms2.2 ISO/ASTM Standards:251204 Practice for Dosimetry in Gamma Irradiation Facili-ties for Food Processing51205 Practice for Use of a Ceric-Cerous Sulfate DosimetrySystem51261 Guide for Selection and

24、 Calibration of DosimetrySystems for Radiation Processing51275 Practice for the Use of a Radiochromic Film Dosim-etry System51276 Practice for the Use of a PolymethylmethacrylateDosimetry System51310 Practice for the Use of a Radiochromic OpticalWaveguide Dosimetry System51401 Practice for Use of a

25、Dichromatic Dosimetry System51431 Practice for Dosimetry in Electron Beam and X-Ray(Bremsstrahlung) Irradiation Facilities for Food Process-ing51538 Practice for Use of the Ethanol-Chlorobenzene Do-simetry System51540 Practice for Use of a Radiochromic Liquid Dosim-etry System51607 Practice for Use

26、of the Alanine-EPR DosimetrySystem51608 Practice for Dosimetry in an X-Ray (Bremmstrahl-ung) Facility for Radiation Processing51631 Practice for Use of Calorimetric Dosimetry Systemsfor Electron Beam Dose Measurements and RoutineDosimeter Calibration51649 Practice for Dosimetry in an Electron-Beam F

27、acilityfor Radiation Processing at Energies Between 300 keVand 25 MeV51650 Practice for Use of Cellulose Triacetate DosimetrySystems51702 Practice for Dosimetry in a Gamma Irradiation Fa-cility for Radiation Processing51707 Guide for Estimating Uncertainties in Dosimetry forRadiation Processing51818

28、 Practice for Dosimetry in an Electron Beam Facilityfor Radiation Processing at Energies Between 80 and 300keV51900 Guide for Dosimetry in Radiation Research on Foodand Agricultural Products51939 Practice for Blood Irradiation Dosimetry51940 Guide for Dosimetry for Sterile Insect Release Pro-grams51

29、956 Practice for Thermoluminescence-Dosimetry (TLD)Systems for Radiation Processing52116 Practice for Dosimetry for a Self-Contained Dry-Storage Gamma-Ray Irradiator1This practice is under the jurisdiction of ASTM Committee E10 on NuclearTechnology and Applications and is the direct responsibility o

30、f SubcommitteeE10.01 on Radiation Processing: Dosimetry and Applications.Current edition approved Aug. 15, 2009. Published September 2009.2For referenced ASTM and ISO/ASTM standards, visit the ASTM website,www.astm.org, or contact ASTM Customer Service at serviceastm.org. ForAnnual Book of ASTM Stan

31、dards volume information, refer to the standardsDocument Summary page on the ASTM website.E26280922.3 ISO Standards:3ISO 11137-1 Sterilization of health care products Radia-tion Part 1: Requirements for development, validationand routine control of a sterilization process for medicaldevicesISO 11137

32、-3 Sterilization of health care products Radia-tion Part 3: Guidance on dosimetric aspectsISO 10012 Measurement managements systems Require-ments for measurement processes and measuring equip-mentISO 17025 General requirements for the competence oftesting and calibration laboratories2.4 Internationa

33、l Commission on Radiation Units andMeasurements (ICRU) Reports:4ICRU Report 60 Fundamental Quantities and Units forIonizing RadiationICRU Report 80 Dosimetry Systems for Use in RadiationProcessing2.5 ISO Reports:3GUM Guide to the Expression of Uncertainty in Measure-ment, 1995VIM International Vocab

34、ulary of Basic and General Termsin Metrology, 19933. Terminology3.1 Definitions:3.1.1 absorbed dosequantity of ionizing radiation energyimparted per unit mass of a specified material. The SI unit ofabsorbed dose is the gray (Gy), where 1 gray is equivalent tothe absorption of 1 joule per kilogram of

35、 the specified material(1 Gy = 1 J/kg). The mathematical relationship is the quotientof dby dm, where dis the mean incremental energy impartedby ionizing radiation to matter of incremental mass dm.3.1.2 accredited dosimetry calibration laboratorydosimetry laboratory with formal recognition by an acc

36、reditingorganization that the dosimetry laboratory is competent 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, u

37、nderspecified conditions, the relationship between values of quan-tities indicated by a measuring instrument or measuring sys-tem, or values represented by a material measure or a referencematerial, and the corresponding values realized by standards.3.1.4 dosimeterdevice that, when irradiated, exhib

38、its aquantifiable change that can be related to absorbed dose in agiven 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 quant

39、ities, fora dosimeter/dosimetry system under defined test conditions.3.1.6 dosimeter response reproducible, quantifiable radia-tion effect produced in the dosimeter.3.1.7 dosimetrymeasurement of absorbed dose by the useof a dosimetry system.3.1.8 dosimetry systemsystem used for measuring ab-sorbed d

40、ose, consisting of dosimeters, measurement instru-ments and their associated reference standards, and proceduresfor the systems use.3.1.9 influence quantityquantity that is not the measurandbut that affects the result of the measurement.3.1.10 measurement management systemset of interre-lated or int

41、eracting 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 qualities and whose value is acceptedwithout reference

42、 to other standards of the same quantity.3.1.12 radiation processingintentional irradiation ofproducts or materials to preserve, modify or improve theircharacteristics.3.1.13 reference standard dosimetry systemdosimetrysystem, generally having the highest metrological qualityavailable at a given loc

43、ation 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 organization, fromwhich measurements made there are deriv

44、ed.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 system and usedfor routine absorbed dose measurements,

45、 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 chain of comparisons all having stated uncertain-ties.3.

46、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

47、 of independent correction factors.3.1.19.1 DiscussionSee Section 6 for examples and fur-ther details.3.1.20 type II dosimeterdosimeter, the response of whichis affected by influence quantities in a complex way that cannotpractically be expressed in terms of independent correctionfactors.3.1.20.1 Di

48、scussionSee Section 6 for examples and fur-ther details.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 and Measure-ments,

49、 7910 Woodmont Ave, Suite 800, Bethesda, MD 20815, USA.E26280933.1.21 uncertaintyparameter associated with the result ofa measurement that characterizes the dispersion of the valuesthat could reasonably be attributed to the measurand or derivedquantity.3.1.22 uncertainty budgetquantitative analysis of thecomponent terms contributing to the uncertainty of a measure-ment, including their statistical distribution, mathematicalmanipulation and summation.3.2 Definitions of other terms used in this standard thatpertain to radiation measurement and do