ANSI ISO ASTM 51539-2005 Standard Guide for Use of Radiation-Sensitive Indicators.pdf

1、ISO/ASTM 51539:2005 (Reapproved 2013)(E)Standard Guide forUse of Radiation-Sensitive Indicators1This standard is issued under the fixed designation ISO/ASTM 51539; the number immediately following the designation indicates theyear of original adoption or, in the case of revision, the year of last re

2、vision.1. Scope1.1 This guide covers procedures for using radiation-sensitive indicators (referred to hereafter as indicators)inradiation processing. These indicators may be labels, papers,inks or packaging materials which undergo a visual changewhen exposed to ionizing radiation (1-5).21.2 The purp

3、ose for using indicators is to determine visuallywhether or not a product has been irradiated, rather than tomeasure different dose levels.1.3 Indicators are not dosimeters and shall not be used as asubstitute for proper dosimetry. Information about dosimetrysystems for radiation processing is provi

4、ded in other ASTMand ISO/ASTM documents (see ISO/ASTM Guide 51261).1.4 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 practices and determine the ap

5、plica-bility of regulatory limitations prior to use.2. Referenced documents2.1 ASTM Standards:3E170 Terminology Relating to Radiation Measurements andDosimetry2.2 ISO/ASTM Standards:351204 Practice for Dosimetry in Gamma Irradiation Facili-ties for Food Processing51261 Practice for Calibration of Ro

6、utine Dosimetry Sys-tems for Radiation Processing51431 Practice for Dosimetry in Electron Beam and X-ray(Bremsstrahlung) Irradiation Facilities for Food Process-ing51608 Practice for Dosimetry in an X-ray (Bremsstrahlung)Facility for Radiation Processing51649 Practice for Dosimetry in an Electron Be

7、am Facilityfor Radiation Processing at Energies between 300 keVand25 MeV51702 Practice for Dosimetry in Gamma Facility for Radia-tion Processing51939 Practice for Blood Irradiation Dosimetry51940 Guide for Dosimetry for Sterile Insect Release Pro-grams2.3 International Commission on Radiation Units

8、and Mea-surements (ICRU) Reports:4ICRU Report 85 Fundamental Quantities and Units forIonizing Radiation3. Terminology3.1 Definitions:3.1.1 dosimetry systemsystem used for determining ab-sorbed dose, consisting of dosimeters, measurement instru-ments and their associated reference standards, and proc

9、eduresfor the systems use.3.1.2 indicatorsee radiation-sensitive indicator.3.1.3 process loadvolume of material with a specifiedproduct loading configuration irradiated as a single entity.3.1.4 radiation-sensitive indicatormaterial such as coatedor impregnated adhesive-backed substrate, ink, coating

10、 or othermaterials which may be affixed to or printed on the processloads, and which undergoes a visual change when exposed toionizing radiation.3.1.4.1 DiscussionThis visual change may be as observedwith the unaided eye or with an eye aid such as an optical filter.3.1.4.2 DiscussionIn the past, rad

11、iation-sensitive indica-tors have been referred to by different names (1-5) includinglabel dosimeters, label indicators, indicator labels, doseindicators, and radiation monitoring labels. ASTM Subcom-mittee E10.01 considers a label dosimeter to be fundamentallydifferent from an indicator, and intend

12、s to define a labeldosimeter as a type of routine dosimeter (that is, quantitative)1This guide is under the jurisdiction of ASTM Committee E61 on RadiationProcessing and is the direct responsibility of Subommittee E61.04 on SpecialtyApplication, and is also under the jurisdiction of ISO/TC 85/WG 3.C

13、urrent edition approved May 27, 2013. Published July 2013. Originallypublished as ASTM E 153993. Last previous ASTM edition E 1539981. ASTME 153993 was adopted by ISO in 1998 with the intermediate designation ISO15564:1998(E). The present International Standard ISO/ASTM51539:2005(2013)(E) replaces I

14、SO 15544 and is a reapproval of the last previousedition ISO/ASTM 51539:2005(E).2The boldface numbers in parentheses refer to the bibliography at the end of thisguide.3For referenced ASTM and ISO/ASTM standards, visit the ASTM website,www.astm.org, or contact ASTM Customer Service at serviceastm.org

15、. ForAnnual Book of ASTM Standards volume information, refer to the standardsDocument Summary page on the ASTM website.4Available from the International Commission on Radiation Units andMeasurements, 7910 Woodmont Ave., Suite 800, Bethesda, MD 20814, USA. ISO/ASTM International 2017 All rights reser

16、vedThis international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for theDevelopment of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Tr

17、ade (TBT) Committee.1that is unique in that it is attached firmly to the product and canbe read out without being removed from the product.3.2 Definitions of other terms used in this standard thatpertain to radiation measurement and dosimetry may be foundin ASTM Terminology E170. Definitions in ASTM

18、 E170 arecompatible with ICRU 85; that document, therefore, may beused as an alternative reference.4. Significance and use4.1 Indicators may be used to show that products have beenexposed to a radiation source. They should be used only toprovide a qualitative indication of radiation exposure and may

19、be used to distinguish processed loads that have been irradiatedfrom unirradiated process loads.NOTE 1The use of indicators does not eliminate the need for otherprocess-control procedures, such as quantitative dosimetry or the con-trolled segregation of irradiated from nonirradiated products.NOTE 2S

20、ee ISO/ASTM Standards 51204, 51431, 51608, 51649,51702, 51939, and 51940 for information on the use of indicators in thevarious types of processing facilities and for unique product applications.4.2 The indicator manufacturer is obliged to supply astatement regarding the approximate dose level at wh

21、ich theexaminer (20/20 vision), at standard illumination (unfiltereddaylight, or artificial light of the spectrum and intensity definedby the proper ASTM standard), is able to determine the visualchange in the indicator.5. Selection of indicators5.1 Indicators should be selected that are convenient

22、to use,will remain attached to the product, and can withstand thestresses of the irradiation process.5.2 Indicators should be selected that have a responsethreshold appropriate for the range of dose experienced by theproduct. The visual change should occur below the minimumdose required for the prod

23、uct. In cases of process interruption,where product does not pass into the path of the primaryradiation field and receives only some scattered radiation, theattached indicator should not show a visual change.5.3 The indicators selected should also have a responsethreshold appropriate for the ranges

24、of dose rate, radiationenergy and environmental conditions experienced by the prod-uct (1).5.4 The suitability of such indicators (under the conditionsof use), from the time of purchase until their use or expirationof their shelf life, shall be determined.5.5 Indicators used for electron beam proces

25、sing should bethin enough to avoid significant influence on the dose distri-bution within the product.5.6 Indicator materials may include, but are not limited to,coated or impregnated adhesive-backed substrates, inks andcoatings (1-5).6. Application6.1 Indicators may be used to help ensure that the

26、processload has been irradiated.6.2 Indicators may be used to ensure segregation of irradi-ated product from non-irradiated product within the radiationprocessing facility.6.3 In the event of interruption of the irradiation process,indicators attached to product may help to locate the specificzone o

27、f process interruption, thereby minimizing the amount ofdiscarded product.6.4 Indicators may be used for monitoring multiple-sidedirradiation processes. In the case of such a process where theabsorbed dose at the far side of the product is sufficient to affectthe indicator, an unexposed indicator co

28、uld be affixed to theside of the product that will face the radiation source before thefirst exposure and between each subsequent exposure.NOTE 3There are other means of monitoring multiple-sided productirradiation, such as the use of bar code labels and automatic turnovermechanisms.7. Limitations o

29、f use7.1 Radiation-sensitive indicators do not have suitable char-acteristics for quantitative, accurate dose measurement.Therefore, indicators are not dosimeters, and shall not be usedas a substitute for proper dosimetry.7.2 Exposure to environmental conditions such as heat,daylight, ultraviolet ra

30、diation, and gases produced by theirradiation process may cause undesirable changes to some ofthese indicator materials (1-4). Thus, indicators may only beuseful within the irradiation facility where environmentalconditions can be controlled. The user should be aware of andfollow any special handlin

31、g and storage procedures that wouldminimize such effects. Information about such potential envi-ronmental influences upon the indicator should be obtainedfrom the manufacturer or from published data.NOTE 4Some irradiation or storage conditions may result in either anunirradiated indicator falsely in

32、dicating it was irradiated, or an irradiatedindicator falsely indicating it was not irradiated (false positive or falsenegative observations).7.3 For the reasons stated above, indicators shall not be usedas the basis for product release.8. Keywords8.1 electron beam; gamma radiation; ionizing radiati

33、on;irradiation; radiation indicator; radiation processing; radiation-sensitive indicator; X-radiation; X-raysISO/ASTM 51539:2005 (2013)(E)2 ISO/ASTM International 2017 All rights reserved Bibliography(1) Abdel-Rahim, F., Miller, A., and McLaughlin, W. L., “Response ofRadiation Monitoring Labels to G

34、amma Rays and Electrons,” Radia-tion Physics and Chemistry, Vol 25, Nos 4-6, 1985, pp. 767-775.(2) Raem, D., “Dosimetric Performances of and Environmental Effectson Sterin Irradiation Indicator Labels,” Radiation Physics andChemistry, Vol 49, No. 4, 1997, pp. 491-495.(3) Prusik, T., Montesalvo, M.,

35、and Wallace, T., “Use of Polydiacetylenesin an Automated Label Dosimetry System,” Radiation Physics andChemistry, Vol 31, Nos. 4-6, 1988, pp. 441-447.(4) Patel, G. N., “Diacetylenes as Radiation Dosage Indicators,” Radia-tion Physics and Chemistry, Vol 18, Nos 5-6, 1981, pp. 913-925.(5) Ehlermann, D

36、. A. E., “Validation of a Label Dosimeter for FoodIrradiation Applications by Subjective and Objective Means,” Appl.Radiat. Isot., Vol 48, No. 9, 1997, pp. 1197-1201.ASTM International takes no position respecting the validity of any patent rights asserted in connection with any item mentionedin thi

37、s standard. Users of this standard are expressly advised that determination of the validity of any such patent rights, and the riskof infringement of such rights, are entirely their own responsibility.This standard is subject to revision at any time by the responsible technical committee and must be

38、 reviewed every five years andif not revised, either reapproved or withdrawn. Your comments are invited either for revision of this standard or for additional standardsand should be addressed to ASTM International Headquarters. Your comments will receive careful consideration at a meeting of theresp

39、onsible technical committee, which you may attend. If you feel that your comments have not received a fair hearing you shouldmake your views known to the ASTM Committee on Standards, at the address shown below.This standard is copyrighted by ISO, Case postate 56, CH-1211, Geneva 20, Switzerland, and

40、 ASTM International, 100 BarrHarbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States. Individual reprints (single or multiple copies) of thisstandard may be obtained by contacting ASTM at the above address or at 610-832-9585 (phone), 610-832-9555 (fax), orserviceastm.org (e-mail); or through the ASTM website (www.astm.org). Permission rights to photocopy the standard may also besecured from the ASTM website (www.astm.org/COPYRIGHT/).ISO/ASTM 51539:2005 (2013)(E)3 ISO/ASTM International 2017 All rights reserved