ISO ASTM 51539-2013 Guide for use of radiation-sensitive indicators《辐射敏感性指示计使用指南》.pdf

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1、 Reference number ISO/ASTM 51539:2013(E) ISO/ASTM International 2013ISO/ASTM 51539 Third edition 2013-10-01 Guide for use of radiation-sensitive indicators Guide pour lutilisation dindicateurs sensibles aux rayonnements ISO/ASTM 51539:2013(E) ISO/ASTM International 2013 All rights reserved. Unless o

2、therwise specif ied, no part of this publication may be reproduced or utilized in any form or by an y means, electronic or mechanical, including photocopying and microfilm, w ithout permission in wr iting from either ISO at the address be low or ISOs member body in the country of the requester. In t

3、he United States, such requests should be sent to ASTM International. ISO copyright office ASTM International, 100 Barr Harbor Drive, PO Box C700, Case postale 56 CH-1211 Geneva 20 West Conshohocken, PA 19428-2959, USA Tel. + 41 22 749 01 11 Tel. +610 832 9634 Fax + 41 22 749 09 47 Fax +610 832 9635

4、 E-mail copyrightiso.org E-mail khooperastm.org Web www.iso.org Web www.astm.org Published in Switzerland ii ISO/ASTM International 2013 All rights reservedISO/ASTM 51539:2013(E) ISO/ASTM International 2013 All rights reserved iiiForeword ISO (the International Organization for Standardization) is a

5、 worldwide federation of national standards bodies (ISO member bodies). The work of preparing Internat ional Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be repr esen

6、ted on that committee. Internat ional organizations, governmental and non-governmental, in li aison with ISO, also ta ke pa rt in th e work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. Draft International Stand

7、ards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at l east 75% of the member bodies casting a vote. Attention is drawn to t he possibility t hat some of the elements of this do cument may be the sub

8、ject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO/ASTM 52915 was prepared by ASTM Internati onal (a s ASTM F2915) and was adopted, under a special “fast-track procedure”, by Technical Committee ISO/TC 261, Additive manufacturing, in parallel

9、with its approval by the ISO m ember bodies. This has been done under a P artner Standards Development Organization (PSDO) agreement on cooperation between ISO/TC 261, Additive manufacturing, and ASTM International committee F42, Additive Manufacturing. ISO/ASTM 51539:2005(Reapproved 2013) An Americ

10、an National Standard Standard Guide for Use of Radiation-Sensitive Indicators 1 This standard is issued under the xed designation ISO/ASTM 51539; the number immediately following the designation indicates the year of original adoption or , in the case of revision, the year of last revision. 1. Scope

11、 1.1 This guide covers procedures for using radiation- sensitive indicators (referred to hereafter as indicators) in radiation processing. These indicators may be labels, papers, inks or packaging materials which under go a visual change when exposed to ionizing radiation (1-5). 2 1.2 The purpose fo

12、r using indicators is to determine visually whether or not a product has been irradiated, rather than to measure dif ferent dose levels. 1.3 Indicators are not dosimeters and shall not be used as a substitute for proper dosimetry . Information about dosimetry systems for radiation processing is prov

13、ided in other ASTM and ISO/ASTM documents (see ISO/ASTM Guide 51261). 1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appro- priate safety and health practices and determine

14、the applica- bility of regulatory limitations prior to use. 2. Referenced documents 2.1 ASTM Standards: 3 E 170 T erminology Relating to Radiation Measurements and Dosimetry 2.2 ISO/ASTM Standards: 3 51204 Practice for Dosimetry in Gamma Irradiation Facili- ties for Food Processing 51261 Practice fo

15、r Calibration of Routine Dosimetry Sys- tems for Radiation Processing 51431 Practice for Dosimetry in Electron Beam and X-ray (Bremsstrahlung) Irradiation Facilities for Food Process- ing 51608 Practice for Dosimetry in an X-ray (Bremsstrahlung) Facility for Radiation Processing 51649 Practice for D

16、osimetry in an Electron Beam Facility for Radiation Processing at Ener gies between 300 keV and 25 MeV 51702 Practice for Dosimetry in Gamma Facility for Radia- tion Processing 51939 Practice for Blood Irradiation Dosimetry 51940 Guide for Dosimetry for Sterile Insect Release Pro- grams 2.3 Internat

17、ional Commission on Radiation Units and Measurements (ICRU) Reports: 4 ICRU Report 85 Fundamental Quantities and Units for Ionizing Radiation 3. Terminology 3.1 Denitions: 3.1.1 dosimetry systemsystem used for determining ab- sorbed dose, consisting of dosimeters, measurement instru- ments and their

18、 associated reference standards, and procedures for the systems use. 3.1.2 indicatorsee radiation-sensitive indicator . 3.1.3 process loadvolume of material with a specied product loading conguration irradiated as a single entity . 3.1.4 radiation-sensitive indicatormaterial such as coated or impreg

19、nated adhesive-backed substrate, ink, coating or other materials which may be af f ixed to or printed on the process loads, and which under goes a visual change when exposed to ionizing radiation. 3.1.4.1 DiscussionThis visual change may be as observed with the unaided eye or with an eye aid such as

20、 an optical lter . 3.1.4.2 DiscussionIn the past, radiation-sensitive indica- tors have been referred to by dif ferent names (1-5) including label dosimeters, label indicators, indicator labels, dose indi- cators, and radiation monitoring labels . ASTM Subcommittee E10.01 considers a label dosimeter

21、 to be fundamentally dif fer - ent from an indicator, and intends to dene a label dosimeter as a type of routine dosimeter (that is, quantitative) that is unique in that it is attached rmly to the product and can be read out without being removed from the product. 3.2 Denitions of other terms used i

22、n this standard that pertain to radiation measurement and dosimetry may be found in ASTM T erminology E 170. Denitions in ASTM E 170 are compatible with ICRU 85; that document, therefore, may be used as an alternative reference. 1 This guide is under the jurisdiction of ASTM Committee E61 on Radiati

23、on Processing and is the direct responsibility of Subommittee E61.04 on Specialty Application, and is also under the jurisdiction of ISO/TC 85/WG 3. Current edition approved by ASTM Jan. 1, 2013. Published XX, XX. Originally published as ASTM E 153993. Last previous ASTM edition E 153998 1 . ASTM E

24、153993 was adopted by ISO in 1998 with the intermediate designation ISO 15564:1998(E). The present International Standard ISO/ASTM 51539:2005(20XX)(E) replaces ISO 15544 and is a reapproval of the last previous edition ISO/ASTM 51539:2005(E). 2 The boldface numbers in parentheses refer to the biblio

25、graphy at the end of this guide. 3 For referenced ASTM and ISO/ASTM standards, visit the ASTM website, www .astm.or g, or contact ASTM Customer Service at serviceastm.or g. For Annual Book of ASTM Standards volume information, refer to the standards Document Summary page on the ASTM website. 4 A vai

26、lable from the International Commission on Radiation Units and Measure- ments, 7910 W oodmont A ve., Suite 800, Bethesda, MD 20814, USA. 1 ISO/ASTM International 2013 All rights reserved4. Signicance and use 4.1 Indicators may be used to show that products have been exposed to a radiation source. Th

27、ey should be used only to provide a qualitative indication of radiation exposure and may be used to distinguish processed loads that have been irradiated from unirradiated process loads. N OTE 1The use of indicators does not eliminate the need for other process-control procedures, such as quantitati

28、ve dosimetry or the con- trolled segregation of irradiated from nonirradiated products. N OTE 2See ISO/ASTM Standards 51204, 51431, 51608, 51649, 51702, 51939, and 51940 for information on the use of indicators in the various types of processing facilities and for unique product applications. 4.2 Th

29、e indicator manufacturer is obliged to supply a statement regarding the approximate dose level at which the examiner (20/20 vision), at standard illumination (unltered daylight, or articial light of the spectrum and intensity dened by the proper ASTM standard), is able to determine the visual change

30、 in the indicator . 5. Selection of indicators 5.1 Indicators should be selected that are convenient to use, will remain attached to the product, and can withstand the stresses of the irradiation process. 5.2 Indicators should be selected that have a response threshold appropriate for the range of d

31、ose experienced by the product. The visual change should occur below the minimum dose required for the product. In cases of process interruption, where product does not pass into the path of the primary radiation eld and receives only some scattered radiation, the attached indicator should not show

32、a visual change. 5.3 The indicators selected should also have a response threshold appropriate for the ranges of dose rate, radiation ener gy and environmental conditions experienced by the prod- uct (1). 5.4 The suitability of such indicators (under the conditions of use), from the time of purchase

33、 until their use or expiration of their shelf life, shall be determined. 5.5 Indicators used for electron beam processing should be thin enough to avoid signicant inuence on the dose distri- bution within the product. 5.6 Indicator materials may include, but are not limited to, coated or impregnated

34、 adhesive-backed substrates, inks and coatings (1-5). 6. Application 6.1 Indicators may be used to help ensure that the process load has been irradiated. 6.2 Indicators may be used to ensure segregation of irradi- ated product from non-irradiated product within the radiation processing facility . 6.

35、3 In the event of interruption of the irradiation process, indicators attached to product may help to locate the specic zone of process interruption, thereby minimizing the amount of discarded product. 6.4 Indicators may be used for monitoring multiple-sided irradiation processes. In the case of suc

36、h a process where the absorbed dose at the far side of the product is suf f icient to af fect the indicator , an unexposed indicator could be af f ixed to the side of the product that will face the radiation source before the rst exposure and between each subsequent exposure. N OTE 3There are other

37、means of monitoring multiple-sided product irradiation, such as the use of bar code labels and automatic turnover mechanisms. 7. Limitations of use 7.1 Radiation-sensitive indicators do not have suitable char - acteristics for quantitative, accurate dose measurement. There- fore, indicators are not

38、dosimeters, and shall not be used as a substitute for proper dosimetry . 7.2 Exposure to environmental conditions such as heat, daylight, ultraviolet radiation, and gases produced by the irradiation process may cause undesirable changes to some of these indicator materials (1-4). Thus, indicators ma

39、y only be useful within the irradiation facility where environmental conditions can be controlled. The user should be aware of and follow any special handling and storage procedures that would minimize such ef fects. Information about such potential envi- ronmental inuences upon the indicator should

40、 be obtained from the manufacturer or from published data. N OTE 4Some irradiation or storage conditions may result in either an unirradiated indicator falsely indicating it was irradiated, or an irradiated indicator falsely indicating it was not irradiated (false positive or false negative observat

41、ions). 7.3 For the reasons stated above, indicators shall not be used as the basis for product release. 8. Keywords 8.1 electron beam; gamma radiation; ionizing radiation; irradiation; radiation indicator; radiation processing; radiation- sensitive indicator; X-radiation; X-rays ISO/ASTM 51539:2005(

42、2013)(E) 2 ISO/ASTM International 2013 All rights reservedBibliography (1) Abdel-Rahim, F ., Miller , A., and McLaughlin, W . L., “Response of Radiation Monitoring Labels to Gamma Rays and Electrons,” Radia- tion Physics and Chemistry, V ol 25, Nos 4-6, 1985, pp. 767-775. (2) Raz em, D., “Dosimetric

43、 Performances of and Environmental Ef fects on Sterin Irradiation Indicator Labels,” Radiation Physics and Chem- istry, V ol 49, No. 4, 1997, pp. 491-495. (3) Prusik, T ., Montesalvo, M., and W allace, T ., “Use of Polydiacetylenes in an Automated Label Dosimetry System,” Radiation Physics and Chemi

44、stry, V ol 31, Nos. 4-6, 1988, pp. 441-447. (4) Patel, G. N., “Diacetylenes as Radiation Dosage Indicators,”Radiation Physics and Chemistry, V ol 18, Nos 5-6, 1981, pp. 913-925. (5) Ehlermann, D. A. E., “V alidation of a Label Dosimeter for Food Irradiation Applications by Subjective and Objective M

45、eans,” Appl. Radiat. Isot., V ol 48, No. 9, 1997, pp. 1 197-1201. ASTM International takes no position respecting the validity of any patent rights asserted in connection with any item mentioned in this standard. Users of this standard are expressly advised that determination of the validity of any

46、such patent rights, and the risk of 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 reviewed every ve years and ifnotrevised,eitherreapprovedorwithdrawn.Yourcommentsareinvitedeithe

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48、 should make your views known to the ASTM Committee on Standards, at the address shown below. ThisstandardiscopyrightedbyISO,Casepostale56,CH-1211,Geneva20,Switzerland,andASTMInternational,100BarrHarbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States. Individual reprints (single

49、or multiple copies) of this standard may be obtained by contacting ASTM at the above address or at 610-832-9585 (phone), 610-832-9555 (fax), or serviceastm.org (e-mail); or through theASTM website (www.astm.org). Permission rights to photocopy the standard may also be secured from the ASTM website (www.astm.org/COPYRIGHT/). ISO/ASTM 51539:2005(2013)(E) 3 ISO/ASTM International 2013 All rights reservedISO/ASTM 51539:2013(E) ICS 17.240 Price based on 3 pages ISO/ASTM International 2013 All rights reserved