1、INTERNATIONAL STANDARD ISO/ASTM 52303 First edition 2015-07-15 Guide for absorbed-dose mapping in ra- diation processing facilities Guide pour la cartographie de dose absorbe du rayonnement des installations de traitement Reference number ISO/ASTM 52303:2015(E) ISO/ASTM International 2015 ISO/ASTM I
2、nternational 2015 All rights reserved. Unless otherwise specied, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microlm, without permission in writing from either ISO at the address below or ISOs member body
3、 in the country of the requester. In the United States, such requests should be sent to ASTM International. ISO copyright office Case postale 56 CH-1211 Geneva 20 Tel. +41 22 749 01 11 Fax +41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org ASTM International,100 Barr Harbor Drive, PO Box C700,
4、 West Conshohocken, PA 19428-2959, USA Tel. +610 832 9634 Fax +610 832 9635 E-mail khooperastm.org Web www.astm.org Published in Switzerland ISO/ASTM 52303:2015(E) ii ISO/ASTM International 2015 All rights reserved Contents Page 1 Scope. 1 2 Referenced Documents . 1 3 Terminology 2 4 Signicance and
5、use 2 5 Prerequisites 3 6 Dose mapping 3 7 Analysis of dose map data 6 8 Measurement uncertainty. 6 9 Documentation accumulation. 6 10 Keywords 7 Figure1 AnExampleofaDosimeterPlacementArrayinaThree-DimensionalGridPatternforan Operational Qualication Dose Mapping. 4 Table X1.1 Summary dose measuremen
6、ts and analysis. 9 Table X1.1 Summary dose measurements and analysis (continued) 10 ISO/ASTM 52303:2015(E) ISO/ASTM International 2015 All rights reserved iii Foreword ISO(theInternationalOrganizationforStandardization)isaworldwidefederationofnationalstandardsbodies (ISO member bodies). The work of
7、preparing International 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 represented on that committee. International organizations, governmental and non-governmental,
8、 in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Pu
9、blication as an International Standard requires approval by at least 75% of the member bodies casting a vote. ASTM International is one of the worlds largest voluntary standards development organizations with global participation from affected stakeholders. ASTM technical committees follow rigorous
10、due process balloting procedures. A project between ISO and ASTM International has been formed to develop and maintain a group of ISO/ASTM radiation processing dosimetry standards. Under this project, ASTM Commitee E61, Radiation Processing, is responsible for the development and maintenance of thes
11、e dosimetry standards with unrestricted participation and input from appropriate ISO member bodies. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. Neither ISO nor ASTM International shall be held responsible for identifying any o
12、r all such patent rights. International Standard ISO/ASTM 52303 was developed by ASTM Committee E61, Radiation Processing, through Subcommittee E61.03, Dosimetry Application, and by Technical Committee ISO/TC 85, Nuclear energy, nuclear technologies and radiological protection. This rst edition canc
13、els and replaces ASTM E2303-11, which has been technically revised. ISO/ASTM 52303:2015(E) iv ISO/ASTM International 2015 All rights reserved ISO/ASTM 52303:2015(E) An American National Standard Standard Guide for Absorbed-Dose Mapping in Radiation Processing Facilities 1 This standard is issued und
14、er the xed designation ISO/ASTM 52303; 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 1.1 This document provides guidance in determining absorbed-dose distributions (mapping) in products, mater
15、ials orsubstancesirradiatedingamma,X-ray(bremsstrahlung)and electron beam facilities. NOTE1Forirradiationoffoodandtheradiationsterilizationofhealth care products, specic ISO and ISO/ASTM standards containing dose mapping requirements exist. See ISO/ASTM Practices 51431, 51608, 51649, 51702 and 51818
16、 and ISO 11137-1. Regarding the radiation sterilization of health care products, in those areas covered by ISO 11137-1, that standard takes precedence. 1.2 This guide is one of a set of standards that provides recommendations for properly implementing dosimetry in radiation processing. it is intende
17、d to be read in conjunction with ISO/ASTM 52628. 1.3 Methods of analyzing the dose map data are described. Examples are provided of statistical methods that may be used to analyze dose map data. 1.4 Dose mapping for bulk ow processing and uid streams is not discussed. 1.5 Dosimetry is an element of
18、a total quality management system for an irradiation facility. Other controls besides do- simetry may be required for specic applications such as medical device sterilization and food preservation. 1.6 This standard does not purport to address all of the safety concerns, if any, associated with its
19、use. It is the responsibility of the user of this standard to establish appro- priate safety and health practices and determine the applica- bility of regulatory requirements prior to use. 2. Referenced Documents 2.1 ASTM Standards: 2 E170Terminology Relating to Radiation Measurements and Dosimetry
20、E178Practice for Dealing With Outlying Observations E2232Guide for Selection and Use of Mathematical Meth- ods for CalculatingAbsorbed Dose in Radiation Process- ing Applications 2.2 ISO/ASTM Standards: 2 51261Guide for Selection and Calibration of Dosimetry Systems for Radiation Processing 51431Pra
21、ctice for Dosimetry in Electron Beam and X-Ray (Bremsstrahlung) Irradiation Facilities for Food Process- ing 51608Practice for Dosimetry in an X-ray (Bremsstrahlung) Facility for Radiation Processing 51649Practice for Dosimetry in an Electron Beam Facility forRadiationProcessingatEnergiesbetween300k
22、eVand 25 MeV 51702Practice for Dosimetry in a Gamma Irradiation Facil- ity for Radiation Processing 51707Guide for Estimating Uncertainties in Dosimetry for Radiation Processing 51818Practice for Dosimetry in an Electron Beam Facility for Radiation Processing at Energies between 80 and 300 keV 52628
23、Practice for Dosimetry in Radiation Processing 2.3 International Commission on Radiation Units and Mea- surements Reports: 3 ICRU Report 85aFundamental Quantities and Units for Ionizing Radiation 2.4 International Organization for Standardization: 4 ISO 11137-1Sterilization of health care products R
24、adia- tion Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices 2.5 Joint Committee for Guides in Metrology (JCGM) Reports: JCGM 100:2008 GUM 1995, with minor corrections, EvaluationofmeasurementdataGuidetotheexpression of uncertainty i
25、n measurement 5 1 This guide is under the jurisdiction of ASTM Committee E61 on Radiation Processing and is the direct responsibility of Subcommittee E61.03 on Dosimetry Application and is also under the jurisdiction of ISO/TC 85/WG 3. Current edition approved Feb. 9, 2015. Published June 2015. Orig
26、inally published as ASTM E230303. Last previous ASTM edition E230311 1 . The present International Standard ISO/ASTM 523032015(E) replaces ASTM E230311 1 . 2 For referenced ASTM and ISO/ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at serviceastm.org. For Ann
27、ual Book of ASTM Standards volume information, refer to the standards Document Summary page on the ASTM website. 3 Available from International Commission on Radiation Units and Measurements, 7910 Woodmont Ave., Suite 800, Bethesda, MD 20814. 4 Available from International Organization for Standardi
28、zation (ISO), 1 rue de Varemb, Case postale 56, CH-1211, Geneva 20, Switzerland. 5 DocumentproducedbyWorkingGroup1oftheJointCommitteeforGuidesin Metrology (JCGM/WG 1). Available free of charge at the BIPM website (http:/ www.bipm.org). ISO/ASTM International 2015 All rights reserved 1JCGM 200:2012,
29、VIMInternational vocabulary of metrol- ogy Basis and general concepts and associated terms 6 3. Terminology 3.1 Denitions: 3.1.1 absorbed-dose mappingmeasurement of absorbed dose within an irradiated product to produce a one-, two- or three-dimensional distribution map of absorbed dose. 3.1.1.1 Disc
30、ussionFor a process load, such a dose map is obtained using dosimeters placed at specied locations within the process load. 3.1.2 calibration curve (VIM:2008)expression of the re- lationbetweenindicationandcorrespondingmeasuredquantity value. 3.1.2.1 DiscussionIn radiation processing standards, the
31、term “dosimeter response” is generally used for “indication.” 3.1.3 dose map, dose mappingsee absorbed-dose map- ping. 3.1.4 dose uniformity ratioratio of the maximum to the minimum absorbed dose within the irradiated product. 3.1.4.1 DiscussionThe concept is also referred to as the max/min dose rat
32、io. Product generally refers to the “process load.” 3.1.5 dose zonea region or discrete point(s) within a process load that receives the same absorbed dose within the statistical uncertainty of the irradiation process and absorbed- dose measurement(s). 3.1.6 installation qualication (IQ)process of o
33、btaining and documenting evidence that equipment has been provided and installed in accordance with its specication. 3.1.7 irradiation containerholderinwhichprocessloadis transported through the irradiator. 3.1.7.1 Discussion“Irradiationcontainer”isoftenreferred to simply as “container” and can be a
34、 carrier, cart, try, product carton, pallet, product package or other holder. 3.1.8 operational qualication (OQ)process of obtaining and documenting evidence that installed equipment operates within predetermined limits when used in accordance with its operational procedures. 3.1.9 performance quali
35、cation (PQ)process of obtaining and documenting evidence that the equipment, as installed and operated in accordance with operational procedures, consis- tently performs in accordance with predetermined criteria and thereby yields product meeting its specication. 3.1.10 process loada volume of mater
36、ial with a specied product loading conguration irradiated as a single entity. 3.1.11 processing categorygroup of different product that can be processed together. 3.1.11.1 DiscussionProcessing categories can be based on, for instance, composition, density or dose requirements. 3.1.12 referencemateri
37、alhomogeneousmaterialofknown radiation absorption and scattering properties used to establish characteristics of the irradiation process, such as scan uniformity,depth-dosedistribution,throughputrate,andrepro- ducibility of dose delivery. 3.1.13 routine monitoring positionposition where ab- sorbed d
38、ose is monitored during routine processing to ensure thattheproductisreceivingtheabsorbeddosespeciedforthe process. 3.1.13.1 DiscussionThis position may be a location of minimumormaximumdoseintheprocessloadoritmaybean alternate convenient location in, on or near the process load where the relationsh
39、ip of the dose at this position with the minimum and maximum dose has been established. 3.1.14 simulated productmaterial with absorption and scatteringpropertiessimilartothoseoftheproduct,materialor substance to be irradiated. 3.1.14.1 DiscussionSimulatedproductisusedduringirra- diator characterizat
40、ion as a substitute for the actual product, material or substance to be irradiated. When used in routine production runs in order to compensate for the absence of product, simulated product is sometimes referred to as com- pensating dummy. When used for absorbed-dose mapping, simulated product is so
41、metimes referred to as phantom mate- rial. 3.2 Denitions of other terms used in this standard that pertain to radiation measurement and dosimetry may be found inTerminology E170. Denitions in E170 are compatible with ICRU Report 60; that document, therefore, may be used as an alternative reference.
42、4. Signicance and use 4.1 This guide is one of a set of guides and practices that provide recommendations for properly implementing dosim- etry in radiation processing. In order to understand and effectively use this and other dosimetry standards, consider rst “Practice for Dosimetry in Radiation Pr
43、ocessing,”ASTM/ ISO 52628, which describes the basic requirements that apply whenmakingabsorbeddosemeasurementsinaccordancewith the ASTM E10.01 series of dosimetry standards. In addition, ASTM/ISO 52628 provides guidance on the selection of dosimetry systems and directs the user to other standards t
44、hat provide information on individual dosimetry systems, calibra- tion methods, uncertainty estimation and radiation processing applications. 4.2 Radiation processing is carried out under xed path conditions where (a) a process load is automatically moved through the radiation eld by mechanical mean
45、s or (b)a process load is irradiated statically by manually placing prod- uct at predetermined positions before the process is started. In both cases the process is controlled in such a manner that the process load position(s) and orientation(s) are reproducible within specied limits. NOTE 2Static i
46、rradiation encompasses irradiation of the process load using either manual rotation, no rotation or automated rotation. 4.3 Some radiation processing facilities that utilize a xed conveyor path for routine processing may also characterize a region within the radiation eld for static radiation proces
47、sing, sometimes referred to as “Off Carrier” processing. 6 DocumentproducedbyWorkingGroup2oftheJointCommitteeforGuidesin Metrology (JCGM/WG 2). Available free of charge at the BIPM website (http:/ www.bipm.org). ISO/ASTM 52303:2015(E) 2 ISO/ASTM International 2015 All rights reserved 4.4 Many radiat
48、ion processing applications require a mini- mum absorbed dose (to achieve a desired effect or to fulll a legal requirement), and a maximum absorbed dose (to ensure that the product, material or substance still meets functional specications or to fulll a legal requirement). 4.5 Information from the d
49、ose mapping is used to: 4.5.1 Characterize the radiation process and assess the reproducibilityofabsorbed-dosevalues,whichmaybeusedas part of operational qualication and performance qualication. 4.5.2 Determine the spatial distribution of absorbed doses and the zone(s) of maximum and minimum absorbed doses throughout a process load, whic
