ISO/ASTM 52628:2020
(Main)Standard practice for dosimetry in radiation processing
Standard practice for dosimetry in radiation processing
This practice describes the basic requirements that apply when making absorbed dose measurements in accordance with the ASTM E61 series of dosimetry standards. In addition, it provides guidance on the selection of dosimetry systems and directs the user to other standards that provide specific information on individual dosimetry systems, calibration methods, uncertainty estimation and radiation processing applications. This practice applies to dosimetry for radiation processing applications using electrons or photons (gamma- or X-radiation). This practice addresses the minimum requirements of a measurement management system, but does not include general quality system requirements. This practice does not address personnel dosimetry or medical dosimetry. This practice does not apply to primary standard dosimetry systems. 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.
Pratique standard pour dosimétrie au traitement par irradiation
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INTERNATIONAL ISO/ASTM
STANDARD 52628
Second edition
2020-04
Standard practice for dosimetry in
radiation processing
Pratique standard pour dosimétrie au traitement par irradiation
Reference number
©
ISO/ASTM International 2020
© ISO/ASTM International 2020
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may be
reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester. In the United States, such requests should be sent to ASTM International.
ISO copyright office ASTM International
CP 401 • Ch. de Blandonnet 8 100 Barr Harbor Drive, PO Box C700
CH-1214 Vernier, Geneva West Conshohocken, PA 19428-2959, USA
Phone: +41 22 749 01 11 Phone: +610 832 9634
Fax: +41 22 749 09 47 Fax: +610 832 9635
Email: copyright@iso.org Email: khooper@astm.org
Website: www.iso.org Website: www.astm.org
Published in Switzerland
ii © ISO/ASTM International 2020 – All rights reserved
Contents Page
1 Scope. 2
2 Referenced documents. 2
3 Terminology. 3
4 Significance and use. 4
5 Dosimetry system requirements. 4
6 Classification. 4
7 Guidance. 6
8 Keywords. 8
Annex. 9
Table 1 Examples of type I dosimeters. 5
Table 2 Examples of type II dosimeters. 6
Table 3 General dosimetry requirements for all radiation processing applications. 6
Table 4 Dosimetry requirements for specific radiation processing applications. 6
Table 5 Guidance for dosimetry in specific radiation processing applications. 7
Table 6 Guidance on absorbed-dose mapping and mathematical methods. 7
Table A1.1 Summary of characteristics of dosimeters described in ASTM and ISO/ASTM
radiation processing standards. 10
© ISO/ASTM International 2020 – All rights reserved iii
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of 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, 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.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted (see www.iso.org/directives).
ASTM International is one of the world’s largest voluntary standards development organizations with
global participation from affected stakeholders. ASTM technical committees follow rigorous due process
balloting procedures.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO and ASTM International shall not be held responsible for identifying any or all such
patent rights. Details of any patent rights identified during the development of the document will be in
the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the World
Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see
www.iso.org/iso/foreword.html.
This document was prepared by ASTM Committee E61, Radiation processing (as ASTM E2628-09), and
drafted in accordance with its editorial rules. It was assigned to Technical Committee ISO/TC 85, Nuclear
energy, nuclear technologies and radiation protection, and adopted under the “fast-track procedure”.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
iv © ISO/ASTM International 2020 – All rights reserved
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.
Standard Practice for
Dosimetry in Radiation Processing
This standard is issued under the fixed designation ISO/ASTM 52628; the number immediately following the designation indicates the
year of original adoption or, in the case of revision, the year of last revision.
INTRODUCTION
The use of ionizing radiation for the treatment of commercial products such as the sterilization of
healthcare products, the reduction of microbial contamination in food or the modification of polymers
is referred to as radiation processing. The types of radiation used may be gamma radiation (typically
from cobalt-60 sources), X-radiation or accelerated electrons.
In some applications, it is necessary to ensure that the specified absorbed dose is applied. In these
cases, the absorbed dose must be measured, and measurement systems have been developed for this
purpose. Much of the development of these systems rests on the early development of dosimetry
systems for personnel radiation protection and for medical treatment. However, the absorbed doses
used in radiation processing are generally higher, ranging from ~10 Gy up to 100 kGy or more and
new dosimetry systems have been developed for measurements of these doses.
Note that the terms “dose” and “absorbed dose” are used interchangeably in this standard (see
3.1.1).
The dose measurements required in radiation processing concern characterization of radiation
facilities in installation qualification (IQ) and operational qualification (OQ), measurement of dose
distribution in irradiated products in performance qualification (PQ) and routine monitoring of the
irradiation process.
The literature is abundant with articles on dosimeters for radiation processing, and guidelines and
standards have been written by several organizations (the International Atomic Energy Agency
(IAEA) and the International Commission on Radiation Units and Measurements (ICRU), for
example) for the operation of the dosimetry systems and for their use in the characterization and
validationoftheradiationprocessingapplications.Inparticular,ICRUReport80providesinformation
on the scientific basis and historical development of many of the systems in current use.
ASTM Subcommittee E10.01 on Radiation Processing: Dosimetry andApplications was formed in
1984 initially with the scope of developing standards for food irradiation, but its scope was widened
to include all radiation processing applications.The subcommittee, now Committee E61, has under its
jurisdiction approximately 30 standard practices and standard guides, collectively known as the E61
standards on radiation processing. A number of these standards have been published as ISO/ASTM
standards, thereby ensuring a wider international acceptance. These practices and guides describe the
dosimetry systems most commonly used in radiation processing, and the dose measurements that are
required in the validation and routine monitoring of the radiation processes. A current list of the E61
standards on radiation processing is given in 2.1 and 2.2.
The development, validation and routine control of a radiation process comprise a number of
activities, most of which rely on the ability to measure the delivered dose accurately. It is therefore
necessary that dose is measured with traceability to national, or international, standards, and the
uncertainty in measured dose is known, including the effect of influence quantities.The E61 standards
on radiation processing dosimetry serve to fulfill these requirements.
The practices describing dosimetry systems have several common attributes, and there is a need to
have one general standard that can act as a common reference and that can be used as a basis for the
selection of dosimetry systems for defined tasks. ISO/ASTM Practice 52628 serves this purpose. It
outlines general requirements for the calibration and use of dosimetry systems and for the estimation
of measurement uncertainties. Details relating to each dosimetry system are found in the respective
standards and each of these refer to ISO/ASTM Practice 52628 for the general requirements.
© ISO/ASTM International 2020 – All rights reserved
1. Scope 51261 Practice for Calibration of Routine Dosimetry Sys-
tems for Radiation Processing
1.1 Thispracticedescribesthebasicrequirementsthatapply
51275 Practice for Use of a Radiochromic Film Dosimetry
when making absorbed dose measurements in accordance with
System
the ASTM E61 series of dosimetry standards. In addition, it
51276 Practice for Use of a Polymethylmethacrylate Dosim-
provides guidance on the selection of dosimetry systems and
etry System
directs the user to other standards that provide specific infor-
51310 Practice for Use of a Radiochromic Optical Wave-
mation on individual dosimetry systems, calibration methods,
guide Dosimetry System
uncertainty estimation and radiation processing applications.
51401 Practice for Use of a Dichromate Dosimetry System
1.2 This practice applies to dosimetry for radiation process-
51538 Practice for Use of the Ethanol-Chlorobenzene Do-
ing applications using electrons or photons (gamma- or
simetry System
X-radiation).
51540 Practice for Use of a Radiochromic Liquid Dosimetry
System
1.3 This practice addresses the minimum requirements of a
measurement management system,butdoesnotincludegeneral 51607 Practice for Use of an Alanine-EPR Dosimetry Sys-
tem
quality system requirements.
51608 Practice for Dosimetry in an X-Ray (Bremsstrahlung)
1.4 This practice does not address personnel dosimetry or
Facility for Radiation Processing at Energies between 50
medical dosimetry.
keV and 7.5 MeV
1.5 This practice does not apply to primary standard dosim-
51631 Practice for Use of Calorimetric Dosimetry Systems
etry systems.
for Electron Beam Dose Measurements and Dosimetry
1.6 This standard does not purport to address all of the System Calibration
safety concerns, if any, associated with its use. It is the 51649 Practice for Dosimetry in an Electron Beam Facility
responsibility of the user of this standard to establish appro- for Radiation Processing at Energies Between 300 keV
priate safety, health, and environmental practices and deter- and 25 MeV
mine the applicability of regulatory limitations prior to use. 51650 Practice for Use of a Cellulose Triacetate Dosimetry
System
2. Referenced documents 51702 Practice for Dosimetry in a Gamma Facility for
2 Radiation Processing
2.1 ASTM Standards:
51707 Guide for Estimation of Measurement Uncertainty in
E2232 Guide for Selection and Use of Mathematical Meth-
Dosimetry for Radiation Processing
ods for Calculating Absorbed Dose in Radiation Process-
51818 Practice for Dosimetry in an Electron Beam Facility
ing Applications
for Radiation Processing at Energies Between 80 and 300
E3083 Terminology Relating to Radiation Processing: Do-
keV
simetry and Applications
51900 Guide for Dosimetry in Radiation Research on Food
F1355 GuideforIrradiationofFreshAgriculturalProduceas
and Agricultural Products
a Phytosanitary Treatment
51939 Practice for Blood Irradiation Dosimetry
F1356 Guide for Irradiation of Fresh, Frozen or Processed
51940 Guide for Dosimetry for Sterile Insect Release
Meat and Poultry to Control Pathogens and Other Micro-
Programs
organisms
51956 PracticeforUseofaThermoluminescence-Dosimetry
F1736 Guide for Irradiation of Finfish and Aquatic Inverte-
(TLD) System for Radiation Processing
brates Used as Food to Control Pathogens and Spoilage
52116 Practice for Dosimetry for a Self-Contained Dry-
Microorganisms
Storage Gamma Irradiator
F1885 Guide for Irradiation of Dried Spices, Herbs, and
52303 Guide for Absorbed Dose Mapping in Radiation
Vegetable Seasonings to Control Pathogens and Other
Processing Facilities
Microorganisms
52701 Guide for Performance Characterization of Dosim-
2.2 ISO/ASTM Standards:
eters and Dosimetry Systems for Use in Radiation Pro-
51026 Practice for Using the Fricke Dosimetry System
cessing
51205 Practice for Use of a Ceric-Cerous Sulfate Dosimetry
2.3 ISO Standards:
System
ISO 11137-1 Sterilization of health care products – Radia-
tion –
...
INTERNATIONAL ISO/ASTM
STANDARD 52628
Second edition
2020-04
Standard practice for dosimetry in
radiation processing
Pratique standard pour dosimétrie au traitement par irradiation
Reference number
©
ISO/ASTM International 2020
© ISO/ASTM International 2020
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may be
reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester. In the United States, such requests should be sent to ASTM International.
ISO copyright office ASTM International
CP 401 • Ch. de Blandonnet 8 100 Barr Harbor Drive, PO Box C700
CH-1214 Vernier, Geneva West Conshohocken, PA 19428-2959, USA
Phone: +41 22 749 01 11 Phone: +610 832 9634
Fax: +41 22 749 09 47 Fax: +610 832 9635
Email: copyright@iso.org Email: khooper@astm.org
Website: www.iso.org Website: www.astm.org
Published in Switzerland
ii © ISO/ASTM International 2020 – All rights reserved
Contents Page
1 Scope. 2
2 Referenced documents. 2
3 Terminology. 3
4 Significance and use. 4
5 Dosimetry system requirements. 4
6 Classification. 4
7 Guidance. 6
8 Keywords. 8
Annex. 9
Table 1 Examples of type I dosimeters. 5
Table 2 Examples of type II dosimeters. 6
Table 3 General dosimetry requirements for all radiation processing applications. 6
Table 4 Dosimetry requirements for specific radiation processing applications. 6
Table 5 Guidance for dosimetry in specific radiation processing applications. 7
Table 6 Guidance on absorbed-dose mapping and mathematical methods. 7
Table A1.1 Summary of characteristics of dosimeters described in ASTM and ISO/ASTM
radiation processing standards. 10
© ISO/ASTM International 2020 – All rights reserved iii
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of 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, 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.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted (see www.iso.org/directives).
ASTM International is one of the world’s largest voluntary standards development organizations with
global participation from affected stakeholders. ASTM technical committees follow rigorous due process
balloting procedures.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO and ASTM International shall not be held responsible for identifying any or all such
patent rights. Details of any patent rights identified during the development of the document will be in
the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the World
Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see
www.iso.org/iso/foreword.html.
This document was prepared by ASTM Committee E61, Radiation processing (as ASTM E2628-09), and
drafted in accordance with its editorial rules. It was assigned to Technical Committee ISO/TC 85, Nuclear
energy, nuclear technologies and radiation protection, and adopted under the “fast-track procedure”.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
iv © ISO/ASTM International 2020 – All rights reserved
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.
Standard Practice for
Dosimetry in Radiation Processing
This standard is issued under the fixed designation ISO/ASTM 52628; the number immediately following the designation indicates the
year of original adoption or, in the case of revision, the year of last revision.
INTRODUCTION
The use of ionizing radiation for the treatment of commercial products such as the sterilization of
healthcare products, the reduction of microbial contamination in food or the modification of polymers
is referred to as radiation processing. The types of radiation used may be gamma radiation (typically
from cobalt-60 sources), X-radiation or accelerated electrons.
In some applications, it is necessary to ensure that the specified absorbed dose is applied. In these
cases, the absorbed dose must be measured, and measurement systems have been developed for this
purpose. Much of the development of these systems rests on the early development of dosimetry
systems for personnel radiation protection and for medical treatment. However, the absorbed doses
used in radiation processing are generally higher, ranging from ~10 Gy up to 100 kGy or more and
new dosimetry systems have been developed for measurements of these doses.
Note that the terms “dose” and “absorbed dose” are used interchangeably in this standard (see
3.1.1).
The dose measurements required in radiation processing concern characterization of radiation
facilities in installation qualification (IQ) and operational qualification (OQ), measurement of dose
distribution in irradiated products in performance qualification (PQ) and routine monitoring of the
irradiation process.
The literature is abundant with articles on dosimeters for radiation processing, and guidelines and
standards have been written by several organizations (the International Atomic Energy Agency
(IAEA) and the International Commission on Radiation Units and Measurements (ICRU), for
example) for the operation of the dosimetry systems and for their use in the characterization and
validationoftheradiationprocessingapplications.Inparticular,ICRUReport80providesinformation
on the scientific basis and historical development of many of the systems in current use.
ASTM Subcommittee E10.01 on Radiation Processing: Dosimetry andApplications was formed in
1984 initially with the scope of developing standards for food irradiation, but its scope was widened
to include all radiation processing applications.The subcommittee, now Committee E61, has under its
jurisdiction approximately 30 standard practices and standard guides, collectively known as the E61
standards on radiation processing. A number of these standards have been published as ISO/ASTM
standards, thereby ensuring a wider international acceptance. These practices and guides describe the
dosimetry systems most commonly used in radiation processing, and the dose measurements that are
required in the validation and routine monitoring of the radiation processes. A current list of the E61
standards on radiation processing is given in 2.1 and 2.2.
The development, validation and routine control of a radiation process comprise a number of
activities, most of which rely on the ability to measure the delivered dose accurately. It is therefore
necessary that dose is measured with traceability to national, or international, standards, and the
uncertainty in measured dose is known, including the effect of influence quantities.The E61 standards
on radiation processing dosimetry serve to fulfill these requirements.
The practices describing dosimetry systems have several common attributes, and there is a need to
have one general standard that can act as a common reference and that can be used as a basis for the
selection of dosimetry systems for defined tasks. ISO/ASTM Practice 52628 serves this purpose. It
outlines general requirements for the calibration and use of dosimetry systems and for the estimation
of measurement uncertainties. Details relating to each dosimetry system are found in the respective
standards and each of these refer to ISO/ASTM Practice 52628 for the general requirements.
© ISO/ASTM International 2020 – All rights reserved
1. Scope 51261 Practice for Calibration of Routine Dosimetry Sys-
tems for Radiation Processing
1.1 Thispracticedescribesthebasicrequirementsthatapply
51275 Practice for Use of a Radiochromic Film Dosimetry
when making absorbed dose measurements in accordance with
System
the ASTM E61 series of dosimetry standards. In addition, it
51276 Practice for Use of a Polymethylmethacrylate Dosim-
provides guidance on the selection of dosimetry systems and
etry System
directs the user to other standards that provide specific infor-
51310 Practice for Use of a Radiochromic Optical Wave-
mation on individual dosimetry systems, calibration methods,
guide Dosimetry System
uncertainty estimation and radiation processing applications.
51401 Practice for Use of a Dichromate Dosimetry System
1.2 This practice applies to dosimetry for radiation process-
51538 Practice for Use of the Ethanol-Chlorobenzene Do-
ing applications using electrons or photons (gamma- or
simetry System
X-radiation).
51540 Practice for Use of a Radiochromic Liquid Dosimetry
System
1.3 This practice addresses the minimum requirements of a
measurement management system,butdoesnotincludegeneral 51607 Practice for Use of an Alanine-EPR Dosimetry Sys-
tem
quality system requirements.
51608 Practice for Dosimetry in an X-Ray (Bremsstrahlung)
1.4 This practice does not address personnel dosimetry or
Facility for Radiation Processing at Energies between 50
medical dosimetry.
keV and 7.5 MeV
1.5 This practice does not apply to primary standard dosim-
51631 Practice for Use of Calorimetric Dosimetry Systems
etry systems.
for Electron Beam Dose Measurements and Dosimetry
1.6 This standard does not purport to address all of the System Calibration
safety concerns, if any, associated with its use. It is the 51649 Practice for Dosimetry in an Electron Beam Facility
responsibility of the user of this standard to establish appro- for Radiation Processing at Energies Between 300 keV
priate safety, health, and environmental practices and deter- and 25 MeV
mine the applicability of regulatory limitations prior to use. 51650 Practice for Use of a Cellulose Triacetate Dosimetry
System
2. Referenced documents 51702 Practice for Dosimetry in a Gamma Facility for
2 Radiation Processing
2.1 ASTM Standards:
51707 Guide for Estimation of Measurement Uncertainty in
E2232 Guide for Selection and Use of Mathematical Meth-
Dosimetry for Radiation Processing
ods for Calculating Absorbed Dose in Radiation Process-
51818 Practice for Dosimetry in an Electron Beam Facility
ing Applications
for Radiation Processing at Energies Between 80 and 300
E3083 Terminology Relating to Radiation Processing: Do-
keV
simetry and Applications
51900 Guide for Dosimetry in Radiation Research on Food
F1355 GuideforIrradiationofFreshAgriculturalProduceas
and Agricultural Products
a Phytosanitary Treatment
51939 Practice for Blood Irradiation Dosimetry
F1356 Guide for Irradiation of Fresh, Frozen or Processed
51940 Guide for Dosimetry for Sterile Insect Release
Meat and Poultry to Control Pathogens and Other Micro-
Programs
organisms
51956 PracticeforUseofaThermoluminescence-Dosimetry
F1736 Guide for Irradiation of Finfish and Aquatic Inverte-
(TLD) System for Radiation Processing
brates Used as Food to Control Pathogens and Spoilage
52116 Practice for Dosimetry for a Self-Contained Dry-
Microorganisms
Storage Gamma Irradiator
F1885 Guide for Irradiation of Dried Spices, Herbs, and
52303 Guide for Absorbed Dose Mapping in Radiation
Vegetable Seasonings to Control Pathogens and Other
Processing Facilities
Microorganisms
52701 Guide for Performance Characterization of Dosim-
2.2 ISO/ASTM Standards:
eters and Dosimetry Systems for Use in Radiation Pro-
51026 Practice for Using the Fricke Dosimetry System
cessing
51205 Practice for Use of a Ceric-Cerous Sulfate Dosimetry
2.3 ISO Standards:
System
ISO 11137-1 Sterilization of health care products – Radia-
tion –
...
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