ASTM ISO ASTM51939-2017 Standard Practice for Blood Irradiation Dosimetry《血液辐射剂量测定的标准实施规程》.pdf

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1、ISO/ASTM 51939:2017(E)Standard Practice forBlood Irradiation Dosimetry1This standard is issued under the fixed designation ISO/ASTM 51939; the number immediately following the designation indicates theyear of original adoption or, in the case of revision, the year of last revision.1. Scope1.1 This p

2、ractice outlines the irradiator installation qualifi-cation program and the dosimetric procedures to be followedduring operational qualification and performance qualificationof the irradiator. Procedures for the routine radiation process-ing of blood product (blood and blood components) are alsogive

3、n. If followed, these procedures will help ensure that bloodproduct exposed to gamma radiation or X-radiation(bremsstrahlung) will receive absorbed doses with a specifiedrange.1.2 This practice covers dosimetry for the irradiation ofblood product for self-contained irradiators (free-standingirradiat

4、ors) utilizing radionuclides such as137Cs and60Co, orX-radiation (bremsstrahlung). The absorbed dose range forblood irradiation is typically 15 Gy to 50 Gy.1.3 The photon energy range of X-radiation used for bloodirradiation is typically from 40 keV to 300 keV.1.4 This practice also covers the use o

5、f radiation-sensitiveindicators for the visual and qualitative indication that theproduct has been irradiated (see ISO/ASTM Guide 51539).1.5 This document is one of a set of standards that providesrecommendations for properly implementing dosimetry inradiation processing and describes a means of ach

6、ievingcompliance with the requirements of ISO/ASTM Practice52628 for dosimetry performed for blood irradiation. It isintended to be read in conjunction with ISO/ASTM Practice52628.1.6 This standard does not purport to address all of thesafety concerns, if any, associated with its use. It is therespo

7、nsibility of the user of this standard to establish appro-priate safety and health practices and to determine theapplicability or regulatory limitations prior to use.2. Referenced documents2.1 ASTM Standards:2E170 Terminology Relating to Radiation Measurements andDosimetry2.2 ISO/ASTM Standards:2510

8、26 Practice for Using the Fricke Dosimetry System51261 Practice for Calibration of Routine Dosimetry Sys-tems for Radiation Processing51275 Practice for Use of a Radiochromic Film DosimetrySystem51310 Practice for Use of a Radiochromic Optical Wave-guide Dosimetry System51539 Guide for the Use of Ra

9、diation-Sensitive Indicators51607 Practice for Use of the Alanine-EPR Dosimetry Sys-tem51707 Guide for Estimating Uncertainties in Dosimetry forRadiation Processing51956 Practice for Use of Thermoluminescence-DosimetrySystems (TLD Systems) for Radiation Processing52116 Practice for Dosimetry for a S

10、elf-Contained Dry-Storage Gamma-Ray Irradiator52628 Practice for Dosimetry in Radiation Processing52701 Guide for Performance Characterization of Dosim-eters and Dosimetry Systems for Use in Radiation Pro-cessing2.3 International Commission on Radiation Units and Mea-surements Reports (ICRU):3ICRU 8

11、0 Dosimetry Systems for Use in Radiation Process-ingICRU 85a Fundamental Quantities and Units for IonizingRadiation1This practice is under the jurisdiction of ASTM Committee E61 on RadiationProcessing and is the direct responsibility of Subcommittee E61.04 on SpecialtyApplication, and is also under

12、the jurisdiction of ISO/TC 85/WG 3.Current edition approved Jan. 16, 2017. Published February 2017. Originallypublished as ASTM E 193998. Last previous ASTM edition E 193998. Thepresent International Standard ISO/ASTM 51939:2017(E) is a revision of the lastprevious edition ISO/ASTM 51939:05(2013)(E)

13、.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 Standards volume information, refer to the standardsDocument Summary page on the ASTM website.3Available from the International Commission on

14、 Radiation Units andMeasurements, 7910 Woodmont Ave., Suite 800, Bethesda, MD 20814 U.S.A. ISO/ASTM International 2017 All rights reservedThis international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles fo

15、r theDevelopment of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.12.4 ISO Standards:412749-4 Nuclear energy Vocabulary Part 4: Dosimetryfor radiation processing2.5 ISO/IEC Standards:417025 General Requirements

16、for the Competence of Testingand Calibration Laboratories2.6 Guidelines on Blood Irradiation:Guidelines on the Use of Irradiated Blood Components(2013), Prepared by the BCSH Blood Transfusion TaskForce5Recommendations Regarding License Amendments andProcedures for Gamma Irradiation of Blood Products

17、,(1993) US Food and Drug Administration6Guidance for Industry, Gamma Irradiation of Blood andBlood Components:APilot Program for Licensing (2000)US Food and Drug Administration62.7 Joint Committee for Guides in Metrology (JCGM)Reports:JCGM 100:2008 GUM 1995, with minor corrections, Evalu-ation of me

18、asurement data Guide to the expression ofuncertainty in measurement7JCGM 200:2012 (JCGM 200:2008 with minor revisions),VIM, International vocabulary of metrology Basis andgeneral concepts and associated terms83. Terminology3.1 Definitions:3.1.1 absorbed dose (D)quotient of d by dm, where d isthe mea

19、n energy imparted by ionizing radiation to matter ofmass dm (see ICRU 85a).D 5 d/dm (1)3.1.1.1 DiscussionThe SI unit of absorbed 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 absorbed-dose rate (D)quotient of

20、 dD by dt, wheredD is the increment of absorbed dose in the time interval dt,thusD5 dD/dt (2)3.1.2.1 DiscussionThe SI unit is Gys1. However, theabsorbed-dose rate is often specified in terms of its averagevalue over longer time intervals, for example, in units ofGymin1or Gyh1.3.1.3 absorbed-dose map

21、pingmeasurement of absorbeddose within an irradiated product to produce a one, two, orthree-dimensional distribution of absorbed dose, thus renderinga map of absorbed-dose values.3.1.3.1 DiscussionFor a blood canister, such a dose map isobtained using dosimeters placed at specified locations withint

22、he canister.3.1.4 activity (A) (of an amount of radionuclide in aparticular energy state at a given time)quotient of dN by dt,where dN is the mean change in the number of nuclei in thatenergy state due to spontaneous nuclear transitions in the timeinterval dt (see ICRU 85a).A 52dN/dt (3)Unit: s1The

23、special name for the unit of activity is the becquerel(Bq). 1 Bq=1s1.3.1.4.1 Discussion(1) The former special unit of activity was the curie (Ci).1Ci=3.71010s1(exactly).(2) The particular energy state is the ground state of thenuclide unless otherwise specified.(3) The activity of an amount of radio

24、nuclide in a particularenergy state is equal to the product of the decay constant, , forthat state and the number of nuclei in that state (that is, A=N).3.1.5 approved laboratorylaboratory that is a recognizednational metrology institute; or has been formally accredited toISO/IEC 17025; or has a qua

25、lity system consistent with therequirements of ISO/IEC 17025.3.1.5.1 DiscussionA recognized national metrology insti-tute or other calibration laboratory accredited to ISO/IEC17025 should be used in order to ensure traceability to anational or international standard. A calibration certificateprovide

26、d by a laboratory not having formal recognition oraccreditation will not necessarily be proof of traceability to anational or international standard.3.1.6 bremsstrahlungbroad-spectrum electromagnetic ra-diation emitted when an energetic charged particle is influ-enced by a strong electric or magneti

27、c field, such as that in thevicinity of an atomic nucleus.3.1.6.1 Discussion(1) In radiation processing, bremsstrahlung photons withsufficient energy to cause ionization are generated by thedeceleration or deflection of energetic electrons in a targetmaterial. When an electron passes close to an ato

28、mic nucleus,the strong coulomb field causes the electron to deviate from itsoriginal motion. This interaction results in a loss of kineticenergy by the emission of electromagnetic radiation. Sincesuch encounters are uncontrolled, they produce a continuousphoton energy distribution that extends up to

29、 the maximumkinetic energy of the incident electron.(2) The bremsstrahlung spectrum depends on the electronenergy, the composition and thickness of the target, and theangle of emission with respect to the incident electron.3.1.7 calibrationset of operations that establish underspecified conditions,

30、the relationship between values of quan-tities indicated by a measuring instrument or measuringsystem, or values represented by a material measure or areference material, and the corresponding values realized bystandards.4Available from International Organization for Standardization (ISO), ISOCentra

31、l Secretariat, BIBC II, Chemin de Blandonnet 8, CP 401, 1214 Vernier,Geneva, Switzerland, http:/www.iso.org.5Available from the National Blood Transfusion Service, East Anglian BloodTransfusion Centre, Long Road, Cambridge, CB2 2PT United Kingdom.6Available from the Office of Communication, Training

32、 and ManufacturersAssistance (HFM-40), 1401 Rockville Pike, Rockville, MD 20852-1488, USA.7Document produced by working Group 1 of the Joint Committee for Guides inMetrology (JCGM WG1). Available free of charage at the BIPM website (http:/www.bipm.org).8Document produced by working Group 2 of the Jo

33、int Committee for Guides inMetrology (JCGM WG2). Available free of charge at the BIPM website (http:/www.bipm.org).ISO/ASTM 51939:2017(E)2 ISO/ASTM International 2017 All rights reserved3.1.7.1 DiscussionCalibration conditions include environ-mental and irradiation conditions present during irradiat

34、ion,storage and measurement of the dosimeters that are used for thegeneration of a calibration curve.3.1.8 dosimeterdevice that, when irradiated, exhibits aquantifiable change that can be related to absorbed dose in agiven material using appropriate measurement instruments andprocedures.3.1.9 dosime

35、ter batchquantity of dosimeters made from aspecific mass of material with uniform composition, fabricatedin a single production run under controlled, consistent condi-tions and having a unique identification code.3.1.10 dosimetry systemsystem used for measuring ab-sorbed dose, consisting of dosimete

36、rs, measurement instru-ments and their associated reference standards, and proceduresfor the systems use.3.1.11 installation qualification (IQ)process of obtainingand documenting evidence that equipment has been providedand installed in accordance with specifications.3.1.12 irradiator turntabledevic

37、e used to rotate thesample during the irradiation process so as to improve doseuniformity.3.1.12.1 DiscussionAn irradiator turntable is often re-ferred to as a turntable. Some irradiator geometries, forexample with a circular array of radiation sources surroundingthe product, may not need a turntabl

38、e.3.1.13 isodose curveslines or surfaces of constant ab-sorbed dose through a specified medium.3.1.14 measurement management systemset of interre-lated or interacting elements necessary to achieve metrologicalconfirmation and continual control of measurement processes.3.1.15 operational qualificatio

39、n (OQ)process of obtainingand documenting evidence that installed equipment operateswithin predetermined limits when used in accordance with itsoperational procedures.3.1.16 performance qualification (PQ)process of obtain-ing and documenting evidence that the equipment as installedand operated in ac

40、cordance with operational procedures, con-sistently performs in accordance with predetermined criteriaand thereby yields product that meeting its specification.3.1.17 radiation-sensitive indicatormaterial such as acoated or impregnated adhesive-backed substrate, ink, coatingor other material which m

41、ay be affixed to or printed on theproduct and which undergoes a visual change when exposed toionizing radiation.3.1.17.1 DiscussionRadiation-sensitive indicators are of-ten referred to as “indicators.”3.1.18 reference-standard dosimetry systemdosimetrysystem, generally having the highest metrologica

42、l qualityavailable at a given location or in a given organization, fromwhich measurements made there are derived.3.1.19 routine dosimetry systemdosimetry system cali-brated against a reference standard dosimetry system and usedfor routine absorbed-dose measurements, including dose map-ping and proce

43、ss monitoring.3.1.20 simulated productmaterial with radiation absorp-tion and scattering properties similar to those of the product,material or substance to be irradiated.3.1.20.1 Discussion(1) Simulated product is used during irradiator character-ization as a substitute for the actual product, mate

44、rial orsubstance to be irradiated.(2) When used in routine production runs in order tocompensate for the absence of product, simulated product issometimes referred to as compensating dummy.(3) When used for absorbed-dose mapping, simulatedproduct is sometimes referred to as phantom material.3.1.21 t

45、imer settingdefined time interval during whichproduct is exposed to radiation.3.1.22 transfer-standard dosimetry systemdosimetry sys-tem used as an intermediary to calibrate other dosimetrysystems.3.1.23 transit doseabsorbed dose delivered to a product(or a dosimeter) while it travels between the no

46、n-irradiationposition and the irradiation position, or in the case of amovable source while the source moves into and out of itsirradiation position.3.1.24 validationdocumented procedure for obtaining, re-cording and interpreting the results to establish that a processwill consistently yield product

47、 complying with predeterminedspecifications.3.1.25 X-radiationionizing electromagnetic radiationwhich includes both bremsstrahlung and the characteristicradiation emitted when atomic electrons make transitions tomore tightly bound states.3.1.25.1 DiscussionIn radiation processing applications(such a

48、s blood product irradiation), the principal X-radiation isbremmstrahlung.3.1.26 X-ray converterdevice for generating X-radiation(bremsstrahlung) from an electron beam, consisting of a target,means for cooling the target, and a supporting structure.3.2 Definitions of Terms Specific to This Standard:3

49、.2.1 blood product (blood and blood components)wholeblood, red cells, frozen cells, platelet concentrates, apheresisplatelets, granulocyte concentrates, and fresh or frozen plasma.3.2.1.1 DiscussionEnclosure systems for blood and bloodcomponents are commonly referred to as “bags.”3.2.2 canistercontainer used to house the blood product orblood-equivalent product during the irradiation process.3.3 Definitions of other terms used in this standard thatpertain to radiation measurement and dosimetry may be foundin I