ASTM E2303-11
(Guide)Standard Guide for Absorbed-Dose Mapping in Radiation Processing Facilities
Standard Guide for Absorbed-Dose Mapping in Radiation Processing Facilities
SIGNIFICANCE AND USE
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.
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.
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.
Many radiation processing applications require a minimum absorbed dose (to achieve a desired effect or to fulfill a legal requirement), and a maximum dose that can be tolerated (while the product, material or substance still meets functional specifications or to fulfill a legal requirement).
Dose mapping is used to:
Characterize the radiation process and assess the reproducibility of absorbed-dose values, which may be used as part of ...
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, other specific ISO and ISO/ASTM standards containing dose mapping requirements exist. For food irradiation, see ISO/ASTM 51204, Practice for Dosimetry in Gamma Irradiation Facilities for Food Processing and ISO/ASTM 51431, Practice for Dosimetry in Electron Beam and X-Ray (Bremsstrahlung) Irradiation Facilities for Food Processing. For the radiation sterilization of health care products, see ISO 11137-1, Sterilization of Health Care Products Radiation – Part 1: Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices. In those areas covered by ISO 11137-1, that standard takes precedence. ISO/ASTM 51608, Practice for Dosimetry in an X-ray (Bremsstrahlung) Facility for Radiation Processing, ISO/ASTM 51649, Practice for Dosimetry in an Electron Beam Facility for Radiation Processing at Energies between 300 keV and 25 Mev, ISO/ASTM 51702, Practice for Dosimetry in a Gamma Irradiation Facility for Radiation Processing, and ISO/ASTM 51818, Practice for Dosimetry in an Electron Beam Facility for Radiation Processing at Energies Between 80 and 300 KeV also contain dose mapping requirements.
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 only one component of a total quality program for an irradiat...
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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. Scope responsibility of the user of this standard to establish appro-
priate safety and health practices and determine the applica-
1.1 This document provides guidance in determining
bility of regulatory requirements prior to use.
absorbed-dose distributions (mapping) in products, materials
orsubstancesirradiatedingamma,X-ray(bremsstrahlung)and
2. Referenced Documents
electron beam facilities.
2
NOTE1—Forirradiationoffoodandtheradiationsterilizationofhealth 2.1 ASTM Standards:
care products, other specific ISO and ISO/ASTM standards containing
E170Terminology Relating to Radiation Measurements and
dose mapping requirements exist. For food irradiation, see ISO/ASTM
Dosimetry
51204, Practice for Dosimetry in Gamma Irradiation Facilities for Food
E178Practice for Dealing With Outlying Observations
Processing and ISO/ASTM 51431, Practice for Dosimetry in Electron
E2232Guide for Selection and Use of Mathematical Meth-
Beam and X-Ray (Bremsstrahlung) Irradiation Facilities for Food Pro-
cessing. For the radiation sterilization of health care products, see ISO ods for CalculatingAbsorbed Dose in Radiation Process-
11137-1, Sterilization of Health Care Products Radiation – Part 1:
ing Applications
Requirements for Development, Validation and Routine Control of a
E2628Practice for Dosimetry in Radiation Processing
Sterilization Process for Medical Devices. In those areas covered by ISO
2
2.2 ISO/ASTM Standards:
11137-1, that standard takes precedence. ISO/ASTM 51608, Practice for
Dosimetry in an X-ray (Bremsstrahlung) Facility for Radiation ISO/ASTM 51204Practice for Dosimetry in Gamma Irra-
Processing, ISO/ASTM 51649, Practice for Dosimetry in an Electron
diation Facilities for Food Processing
Beam Facility for Radiation Processing at Energies between 300 keVand
ISO/ASTM 51261Guide for Selection and Calibration of
25 Mev, ISO/ASTM 51702, Practice for Dosimetry in a Gamma Irradia-
Dosimetry Systems for Radiation Processing
tionFacilityforRadiationProcessing,andISO/ASTM51818,Practicefor
ISO/ASTM 51431Practice for Dosimetry in Electron Beam
Dosimetry in an Electron Beam Facility for Radiation Processing at
Energies Between 80 and 300 KeV also contain dose mapping require-
and X-Ray (Bremsstrahlung) Irradiation Facilities for
ments.
Food Processing
1.2 This guide is one of a set of standards that provides ISO/ASTM 51608Practice for Dosimetry in an X-ray
recommendations for properly implementing dosimetry in (Bremsstrahlung) Facility for Radiation Processing
radiation processing. it is intended to be read in conjunction
ISO/ASTM 51649Practice for Dosimetry in an Electron
with ASTM Practice E2628. Beam Facility for Radiation Processing at Energies be-
tween 300 keV and 25 MeV
1.3 Methods of analyzing the dose map data are described.
ISO/ASTM 51702Practice for Dosimetry in a Gamma
Examples are provided of statistical methods that may be used
Irradiation Facility for Radiation Processing
to analyze dose map data.
ISO/ASTM 51707Guide for Estimating Uncertainties in
1.4 Dose mapping for bulk flow processing and fluid
Dosimetry for Radiation Processing
streams is not discussed.
ISO/ASTM 51818Practice for Dosimetry in an Electron
Beam Facility for Radiation Processing at Energies be-
1.5 Dosimetry is only one component of a total quality
program for an irradiation facility. Other controls besides tween 80 and 300 keV
dosimetry may be required for specific applications such as
2.3 International Commission on Radiation Units and Mea-
3
medical device sterilization and food preservation.
surements Reports:
ICRU Report 60Fundamental Quantities and Units for
1.6 This standard does not purport to address all of the
Ionizing Radiation
safety concerns, if any, associated with its use. It is the
1 2
This guide is under the jurisdiction of ASTM Committee E61 on Radiation For referenced ASTM and ISO/ASTM standards, visit the ASTM website,
Processingand is the direct responsibility of Subcommittee E61.03 on Dosimetry www.astm.org, or contact ASTM Customer Service at service@astm.org. For
Application. Annual Book of ASTM Standards volume information, refer to the standard’s
Current edition approved July 1, 2011. Published August 2011. Originally Document Summary page on the ASTM website.
3
approved in 2003. Last previous edition approved in 2003 as E2303-03. DOI: Available from International Commissio
...
This document is not anASTM standard and is intended only to provide the user of anASTM 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.
An American National Standard
Designation:E2303–03 Designation: E2303 – 11
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. Scope
1.1 Thisdocumentprovidesguidanceindeterminingabsorbed-dosedistributions(mapping)inproducts,materialsorsubstances
irradiated in gamma, X-ray (bremsstrahlung) and electron beam facilities.
NOTE1—For irradiation of food and the radiation sterilization of health care products, other specific ISO and ISO/ASTM standards containing dose
mappingrequirementsexist.Forfoodirradiation,seeISO/ASTM51204,PracticeforDosimetryinGammaIrradiationFacilitiesforFoodProcessingand
ISO/ASTM 51431, Practice for Dosimetry in Electron and Bremsstrahlung Irradiation Facilities for Food Processing. For the radiation sterilizationof
healthcareproducts,seeISO11137:1995,SterilizationofHealthCareProductsRequirementsforValidationandRoutineControlRadiationSterilization.
In those areas covered by ISO 11137, that standard takes precedence. ISO/ASTM Practice 51608, ISO/ASTM Practice 51649, and ISO/ASTM Practice
51702 also contain dose mapping requirements.
1.2Methods of analyzing the dose map data are described. Examples are provided of statistical methods that may be used to
analyze dose map data.
1.3Dose mapping for bulk flow processing and fluid streams is not discussed.
1.4Dosimetry is only one component of a total quality program for an irradiation facility. Other controls besides dosimetry may
be required for specific applications such as medical device sterilization and food preservation.
1.5 1—For irradiation of food and the radiation sterilization of health care products, other specific ISO and ISO/ASTM
standards containing dose mapping requirements exist. For food irradiation, see ISO/ASTM 51204, Practice for Dosimetry in
Gamma Irradiation Facilities for Food Processing and ISO/ASTM 51431, Practice for Dosimetry in Electron Beam and X-Ray
(Bremsstrahlung) Irradiation Facilities for Food Processing. For the radiation sterilization of health care products, see ISO
11137-1, Sterilization of Health Care Products Radiation – Part 1: Requirements for Development, Validation and Routine Control
of a Sterilization Process for Medical Devices. In those areas covered by ISO 11137-1, that standard takes precedence. ISO/ASTM
51608, Practice for Dosimetry in an X-ray (Bremsstrahlung) Facility for Radiation Processing, ISO/ASTM 51649, Practice for
Dosimetry in an Electron Beam Facility for Radiation Processing at Energies between 300 keV and 25 Mev, ISO/ASTM 51702,
Practice for Dosimetry in a Gamma Irradiation Facility for Radiation Processing, and ISO/ASTM 51818, Practice for Dosimetry
in an Electron Beam Facility for Radiation Processing at Energies Between 80 and 300 KeV also contain dose mapping
requirements.
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 Dosimetryisonlyonecomponentofatotalqualityprogramforanirradiationfacility.Othercontrolsbesidesdosimetrymay
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
1
This guide is under the jurisdiction of ASTM Committee E10 on Nuclear Technology and Applications and is the direct responsibility of Subcommittee E10.01 on
Dosimetry for Radiation Processing.
Current edition approved July 10, 2003. Published August 2003 DOI: 10.1520/E2303-03.on Radiation Processing: Dosimetry and Applications.
CurrenteditionapprovedJuly1,2011.PublishedAugust2011.Originallya
...
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