ASTM ISO/ASTM52303-15
(Guide)Standard Guide for Absorbed-Dose Mapping in Radiation Processing Facilities
Standard Guide for Absorbed-Dose Mapping in Radiation Processing Facilities
SIGNIFICANCE AND USE
4.1 This guide is one of a set of guides and practices that provide recommendations for properly implementing dosimetry in radiation processing. In order to understand and effectively use this and other dosimetry standards, consider first “Practice for Dosimetry in Radiation Processing,” ASTM/ISO 52628, which describes the basic requirements that apply when making absorbed dose measurements in accordance with 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 that provide information on individual dosimetry systems, calibration methods, uncertainty estimation and radiation processing applications.
4.2 Radiation processing is carried out under fixed path conditions where (a) a process load is automatically moved through the radiation field by mechanical means or (b) a process load is irradiated statically by manually placing product 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 specified limits.
Note 2: Static irradiation encompasses irradiation of the process load using either manual rotation, no rotation or automated rotation.
4.3 Some radiation processing facilities that utilize a fixed conveyor path for routine processing may also characterize a region within the radiation field for static radiation processing, sometimes referred to as “Off Carrier” processing.
4.4 Many radiation processing applications require a minimum absorbed dose (to achieve a desired effect or to fulfill a legal requirement), and a maximum absorbed dose (to ensure that the product, material or substance still meets functional specifications or to fulfill a legal requirement).
4.5 Information from the dose mapping is used to:
4.5.1 Characterize the radiation process and assess the reproducibility of absorbed-dose...
SCOPE
1.1 This document provides guidance in determining absorbed-dose distributions (mapping) in products, materials or substances irradiated in gamma, X-ray (bremsstrahlung) and electron beam facilities.
Note 1: For irradiation of food and the radiation sterilization of health care products, specific ISO and ISO/ASTM standards containing dose mapping requirements exist. See ISO/ASTM Practices 51431, 51608, 51649, 51702 and 51818 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 intended 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 flow processing and fluid streams is not discussed.
1.5 Dosimetry is an element of a total quality management system for an irradiation facility. Other controls besides dosimetry may be required for specific 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 use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory requirements prior to use.
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ISO/ASTM 52303:2015(E)
Standard Guide for
1
Absorbed-Dose Mapping in Radiation Processing Facilities
This standard is issued under the fixed 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 E178Practice for Dealing With Outlying Observations
E2232Guide for Selection and Use of Mathematical Meth-
1.1 This document provides guidance in determining
ods for CalculatingAbsorbed Dose in Radiation Process-
absorbed-dose distributions (mapping) in products, materials
ing Applications
orsubstancesirradiatedingamma,X-ray(bremsstrahlung)and
2
2.2 ISO/ASTM Standards:
electron beam facilities.
51261Guide for Selection and Calibration of Dosimetry
NOTE1—Forirradiationoffoodandtheradiationsterilizationofhealth
care products, specific ISO and ISO/ASTM standards containing dose
Systems for Radiation Processing
mapping requirements exist. See ISO/ASTM Practices 51431, 51608,
51431Practice for Dosimetry in Electron Beam and X-Ray
51649, 51702 and 51818 and ISO 11137-1. Regarding the radiation
(Bremsstrahlung) Irradiation Facilities for Food Process-
sterilization of health care products, in those areas covered by ISO
ing
11137-1, that standard takes precedence.
51608Practice for Dosimetry in an X-ray (Bremsstrahlung)
1.2 This guide is one of a set of standards that provides
Facility for Radiation Processing
recommendations for properly implementing dosimetry in
51649Practice for Dosimetry in an Electron Beam Facility
radiation processing. it is intended to be read in conjunction
forRadiationProcessingatEnergiesbetween300keVand
with ISO/ASTM 52628.
25 MeV
1.3 Methods of analyzing the dose map data are described.
51702Practice for Dosimetry in a Gamma Irradiation Facil-
Examples are provided of statistical methods that may be used
ity for Radiation Processing
to analyze dose map data.
51707Guide for Estimating Uncertainties in Dosimetry for
Radiation Processing
1.4 Dose mapping for bulk flow processing and fluid
51818Practice for Dosimetry in an Electron Beam Facility
streams is not discussed.
for Radiation Processing at Energies between 80 and 300
1.5 Dosimetry is an element of a total quality management
keV
system for an irradiation facility. Other controls besides do-
52628Practice for Dosimetry in Radiation Processing
simetry may be required for specific applications such as
2.3 International Commission on Radiation Units and Mea-
medical device sterilization and food preservation.
3
surements Reports:
1.6 This standard does not purport to address all of the
ICRU Report 85aFundamental Quantities and Units for
safety concerns, if any, associated with its use. It is the
Ionizing Radiation
responsibility of the user of this standard to establish appro-
4
2.4 International Organization for Standardization:
priate safety and health practices and determine the applica-
ISO 11137-1Sterilization of health care products – Radia-
bility of regulatory requirements prior to use.
tion – Part 1: Requirements for development, validation,
and routine control of a sterilization process for medical
2. Referenced Documents
devices
2
2.1 ASTM Standards:
2.5 Joint Committee for Guides in Metrology (JCGM)
E170Terminology Relating to Radiation Measurements and
Reports:
Dosimetry
JCGM 100:2008 GUM 1995, with minor corrections,
Evaluationofmeasurementdata–Guidetotheexpression
1
5
This guide is under the jurisdiction of ASTM Committee E61 on Radiation
of uncertainty in measurement
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. Originally
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published as ASTM E2303–03. Last previous ASTM edition E2303–11 . The Available from International Commission on Radiation Units and
present International Standard ISO/ASTM 52303–2015(E) replaces ASTM Measurements, 7910 Woodmont Ave., Suite 800, Bethesda, MD 20814.
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4
E2303–11 . Available from International Organization for Standardization (ISO), 1 rue de
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For referenced ASTM and ISO/ASTM standards, visit the ASTM website, Varembé, Case postale 56, CH-1211, Geneva 20, Switzerland.
5
www.astm.org, or contact ASTM Customer Service at service@astm.org. For DocumentproducedbyWorkingGroup1oftheJointCommitteeforGuidesin
Annual Book of ASTM Standards volume information, refer to the standard’s Metrology (JCGM/WG 1). Available free of charge at the BIPM website (http://
Document Summary page on the ASTM website. www.bipm.org).
© ISO/ASTM International 2018 – All rights reserved
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This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
´1
E2303:11
ISO/ASTM 52303 − 2015(E)
An American National Standard
Standard Guide for
1
Absorbed-Dose Mapping in Radiation Processing Facilities
This standard is issued under the fixed designation E2303; 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. A number in parentheses indicates the year
of last reapproval. A superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1
ε NOTE—Editorial changes were made throughout in December 2012.
1. Scope
1.1 This document provides guidance in determining absorbed-dose distributions (mapping) in products, materials or substances
irradiated in gamma, X-ray (bremsstrahlung) and electron beam facilities.
NOTE 1—For irradiation of food and the radiation sterilization of health care products, specific ISO and ISO/ASTM standards containing dose mapping
requirements exist. See ISO/ASTM Practices 51431, 51608, 51649, 51702 and 51818 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 intended to be read in conjunction with ASTM Practice ISO/ASTM E262852628.
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 flow processing and fluid streams is not discussed.
1.5 Dosimetry is an element of a total quality management system for an irradiation facility. Other controls besides dosimetry
may be required for specific 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 use. It is the responsibility
of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory
requirements prior to use.
2. Referenced Documents
2
2.1 ASTM Standards:
E170 Terminology Relating to Radiation Measurements and Dosimetry
E178 Practice for Dealing With Outlying Observations
E2232 Guide for Selection and Use of Mathematical Methods for Calculating Absorbed Dose in Radiation Processing
Applications
E2628 Practice for Dosimetry in Radiation Processing
2
2.2 ISO/ASTM Standards:
51261 Guide for Selection and Calibration of Dosimetry Systems for Radiation Processing
51431 Practice for Dosimetry in Electron Beam and X-Ray (Bremsstrahlung) Irradiation Facilities for Food Processing
51608 Practice for Dosimetry in an X-ray (Bremsstrahlung) Facility for Radiation Processing
51649 Practice for Dosimetry in an Electron Beam Facility for Radiation Processing at Energies between 300 keV and 25 MeV
51702 Practice for Dosimetry in a Gamma Irradiation Facility for Radiation Processing
51707 Guide for Estimating Uncertainties in Dosimetry for Radiation Processing
51818 Practice for Dosimetry in an Electron Beam Facility for Radiation Processing at Energies between 80 and 300 keV
52628 Practice for Dosimetry in Radiation Processing
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 July 1, 2011Feb. 9, 2015. Published August 2011. Originally approved in 2003.June 2015. Originally published as ASTM E2303–03. Last
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previous ASTM edition E2303approved–11 in 2003 as. The present International E2303-03. DOI: 10.1520/E2303-11E01.Standard ISO/ASTM 52303–2015(E) replaces
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ASTM E2303–11 .
2
For referenced ASTM and ISO/ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at service@astm.org. For Annual Book
of ASTM Standards volume information, refer to the standard’s Document Summary page on the ASTM website.
© ISO/ASTM International 2015 – All rights reserved
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ISO/ASTM 52303:2015(E)
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2.3 International Commission on Radiation Units and Measurements Reports:
ICRU Report 6085a Fundamental Quantities and Units for Ionizing Radiation
4
2.4 International Organization for Standardization:
ISO 11137-1 Sterilization of health care products – Radiation – Part 1: Requirements for development, validation, and routine
control of a sterilization pro
...
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