ASTM 52303-24
(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 E61 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 va...
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 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
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This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Designation: 52303 − 24
Standard Guide for
1
Absorbed-Dose Mapping in Radiation Processing Facilities
This standard is issued under the fixed designation 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.
INTRODUCTION
Historically, this document’s scope includes all dose mapping activities (OQ and PQ) for the three
common forms of radiation utilized in facilities. Ongoing work within E61.03 aims to provide the user
with additional guidance on considerations specific to each radiation source type and absorbed-dose
mapping activities. The intent is to keep this document largely whole while these standards are
published over the upcoming years, updating specific sections to reference further guidance that can
be obtained in external documents. A major revision to this document is planned after the balance of
additional guidance documents are approved at which time this Introduction will be removed.
1. Scope responsibility of the user of this standard to establish appro-
priate safety, health, and environmental practices and deter-
1.1 This document provides guidance in determining
mine the applicability of regulatory limitations prior to use.
absorbed-dose distributions (mapping) in products, materials
1.7 This international standard was developed in accor-
or substances irradiated in gamma, X-ray (bremsstrahlung) and
dance with internationally recognized principles on standard-
electron beam facilities.
ization established in the Decision on Principles for the
NOTE 1—For irradiation of food and the radiation sterilization of health
Development of International Standards, Guides and Recom-
care products, specific ISO and ISO/ASTM standards containing dose
mapping requirements exist. See ISO/ASTM Practices 51608, 51649,
mendations issued by the World Trade Organization Technical
51702 and 51818 and ISO 11137-1. Regarding the radiation sterilization
Barriers to Trade (TBT) Committee.
of health care products, in those areas covered by ISO 11137-1, that
standard takes precedence.
2. Referenced Documents
1.2 This guide is one of a set of standards that provides
2
2.1 ASTM Standards:
recommendations for properly implementing dosimetry in
E178 Practice for Dealing With Outlying Observations
radiation processing. It is intended to be read in conjunction
E2232 Guide for Selection and Use of Mathematical Meth-
with ISO/ASTM 52628.
ods for Calculating Absorbed Dose in Radiation Process-
1.3 Methods of analyzing the dose map data are described.
ing Applications
Examples are provided of statistical methods that may be used
E3083 Terminology Relating to Radiation Processing: Do-
to analyze dose map data.
simetry and Applications
1.4 Dose mapping for bulk flow processing and fluid E3239 Guide for Using Statistical Process Control Principles
streams is not discussed. for Routine Dosimetry in Radiation Processing
E3270 Guide for Operational Qualification of Gamma Irra-
1.5 Dosimetry is an element of a total quality management
diators
system for an irradiation facility. Other controls besides do-
2
simetry may be required for specific applications such as
2.2 ISO/ASTM Standards:
medical device sterilization and food preservation. 51261 Practice for Calibration of Routine Dosimetry Sys-
tems for Radiation Processing
1.6 This standard does not purport to address all of the
51608 Practice for Dosimetry in an X-ray (Bremsstrahlung)
safety concerns, if any, associated with its use. It is the
Facility for Radiation Processing
51649 Practice for Dosimetry in an Electron Beam Facility
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. Originally developed as a joint ASTM/ISO standard in conjunction
2
with ISO/TC 85/WG 3. For referenced ASTM and ISO/ASTM standards, visit the ASTM website,
Current edition approved Jan. 1, 2024. Published January 2024. Originally www.astm.org, or contact ASTM Customer Service at service@astm.org. For
approved in 2003. Last previous edition approved in 2015 as ISO/ASTM Annual Book of ASTM Standards volume information, refer to the standard’s
52303–2015(E). DOI:10.1520/52303-24. Document Summary page on the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
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52303 − 24
for Radiation Processing at E
...
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.
Designation: ISO/ASTM 52303 − 2015(E) 52303 − 24
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. A number in parentheses indicates the year of last
reapproval. A superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
INTRODUCTION
Historically, this document’s scope includes all dose mapping activities (OQ and PQ) for the three
common forms of radiation utilized in facilities. Ongoing work within E61.03 aims to provide the user
with additional guidance on considerations specific to each radiation source type and absorbed-dose
mapping activities. The intent is to keep this document largely whole while these standards are
published over the upcoming years, updating specific sections to reference further guidance that can
be obtained in external documents. A major revision to this document is planned after the balance of
additional guidance documents are approved at which time this Introduction will be removed.
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. itIt 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 healthsafety, health, and environmental practices and determine
the applicability of regulatory requirementslimitations prior to use.
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 . Originally developed as a joint ASTM/ISO standard in conjunction with ISO/TC 85/WG 3.
Current edition approved Feb. 9, 2015Jan. 1, 2024. Published January 2024June 2015. Originally published as ASTM. Originally approved in 2003. E2303–03. Last
ε1
previous ASTM edition E2303–11approved . The present International Standard ISO/ASTM 52303–2015(E) replaces ASTM in 2015 as ISO/ASTM 52303–2015(E).
ε1
DOI:10.1520/52303-24.E2303–11 .
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
52303 − 24
1.7 This international standard was developed in accordance with internationally recognized principles on standardization
established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued
by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
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
E3083 Terminology Relating to Radiation Processing: Dosimetry and Applications
E3239 Guide for Using Statistical Process Control Principles for Routine Dosimetry in Radiation Processing
E3270 Guide for Operational Qualification of Gamma Irradiators
2
2.2 ISO/ASTM Standards:
51261 Guide for Selection and Practice for Calibration of Routine Dosimetry System
...
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