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 Practice E2628, 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 Practice E2628 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 absorbe...
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 E2628.  
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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30-Jun-2011
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Designation: E2303 − 11 AnAmerican National Standard
Standard Guide for
1
Absorbed-Dose Mapping in Radiation Processing Facilities
This standard is issued under the fixed designation E2303; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision.Anumber 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 E170Terminology Relating to Radiation Measurements and
Dosimetry
1.1 This document provides guidance in determining
E178Practice for Dealing With Outlying Observations
absorbed-dose distributions (mapping) in products, materials
E2232Guide for Selection and Use of Mathematical Meth-
orsubstancesirradiatedingamma,X-ray(bremsstrahlung)and
ods for CalculatingAbsorbed Dose in Radiation Process-
electron beam facilities.
ing Applications
NOTE1—Forirradiationoffoodandtheradiationsterilizationofhealth
E2628Practice for Dosimetry in Radiation Processing
care products, specific ISO and ISO/ASTM standards containing dose
mapping requirements exist. See ISO/ASTM Practices 51431, 51608,
2
2.2 ISO/ASTM Standards:
51649, 51702 and 51818 and ISO 11137-1. Regarding the radiation
51261Guide for Selection and Calibration of Dosimetry
sterilization of health care products, in those areas covered by ISO
Systems for Radiation Processing
11137-1, that standard takes precedence.
51431Practice for Dosimetry in Electron Beam and X-Ray
1.2 This guide is one of a set of standards that provides
(Bremsstrahlung) Irradiation Facilities for Food Process-
recommendations for properly implementing dosimetry in
ing
radiation processing. it is intended to be read in conjunction
51608Practice for Dosimetry in an X-ray (Bremsstrahlung)
with ASTM Practice E2628.
Facility for Radiation Processing
1.3 Methods of analyzing the dose map data are described.
51649Practice for Dosimetry in an Electron Beam Facility
Examples are provided of statistical methods that may be used
forRadiationProcessingatEnergiesbetween300keVand
to analyze dose map data.
25 MeV
51702Practice for Dosimetry in a Gamma Irradiation Facil-
1.4 Dose mapping for bulk flow processing and fluid
streams is not discussed. ity for Radiation Processing
51707Guide for Estimating Uncertainties in Dosimetry for
1.5 Dosimetry is an element of a total quality management
Radiation Processing
system for an irradiation facility. Other controls besides do-
51818Practice for Dosimetry in an Electron Beam Facility
simetry may be required for specific applications such as
for Radiation Processing at Energies between 80 and 300
medical device sterilization and food preservation.
keV
1.6 This standard does not purport to address all of the
2.3 International Commission on Radiation Units and Mea-
safety concerns, if any, associated with its use. It is the
3
surements Reports:
responsibility of the user of this standard to establish appro-
ICRU Report 60Fundamental Quantities and Units for
priate safety and health practices and determine the applica-
Ionizing Radiation
bility of regulatory requirements prior to use.
4
2.4 International Organization for Standardization:
2. Referenced Documents
ISO 11137-1Sterilization of health care products – Radia-
2
tion – Part 1: Requirements for development, validation,
2.1 ASTM Standards:
and routine control of a sterilization process for medical
devices
1
This guide is under the jurisdiction of ASTM Committee E61 on Radiation
GUM Guide to the Expression of Uncertainty in
Processingand is the direct responsibility of Subcommittee E61.03 on Dosimetry
Measurement, 1995, ISBN 92-6710188-9
Application.
Current edition approved July 1, 2011. Published August 2011. Originally
approved in 2003. Last previous edition approved in 2003 as E2303-03. DOI:
10.1520/E2303-11E01.
2 3
For referenced ASTM and ISO/ASTM standards, visit the ASTM website, Available from International Commission on Radiation Units and
www.astm.org, or contact ASTM Customer Service at service@astm.org. For Measurements, 7910 Woodmont Ave., Suite 800, Bethesda, MD 20814.
4
Annual Book of ASTM Standards volume information, refer to the standard’s Available from International Organization for Standardization (ISO), 1 rue de
Document Summary page on the ASTM website. Varembé, Case postale 56, CH-1211, Geneva 20, Switzerland.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
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E2303 − 11
VIMInternational Vocabulary of Basic and General Terms 3.1.13 routine monitoring position—position where ab-
in Metrology sorbed dose is monitored during routine processing to ensure
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