ISO/ASTM 51818:2020
(Main)Practice for dosimetry in an electron beam facility for radiation processing at energies between 80 and 300 keV
Practice for dosimetry in an electron beam facility for radiation processing at energies between 80 and 300 keV
This practice covers dosimetric procedures to be followed in installation qualification, operational qualification and performance qualification (IQ, OQ, PQ), and routine processing at electron beam facilities to ensure that the product has been treated with an acceptable range of absorbed doses. Other procedures related to IQ, OQ, PQ, and routine product processing that may influence absorbed dose in the product are also discussed. The electron beam energy range covered in this practice is between 80 and 300 keV, generally referred to as low energy. Dosimetry is only one component of a total quality assurance program for an irradiation facility. Other measures may be required for specific applications such as medical device sterilization and food preservation. Other specific ISO and ASTM standards exist for the irradiation of food and the radiation sterilization of health care products. For the radiation sterilization of health care products, see ISO 11137-1. In those areas covered by ISO 11137-1, that standard takes precedence. For food irradiation, see ISO 14470. Information about effective or regulatory dose limits for food products is not within the scope of this practice (see ASTM F1355 and F1356). This document is one of a set of standards that provides recommendations for properly implementing dosimetry in radiation processing, and describes a means of achieving compliance with the requirements of ISO/ASTM 52628. It is intended to be read in conjunction with ISO/ASTM 52628. 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. 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.
Pratique de la dosimétrie dans une installation de traitement par irradiation utilisant un faisceau d'électrons d'énergies comprises entre 80 et 300 keV
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INTERNATIONAL ISO/ASTM
STANDARD 51818
Fourth edition
2020-06
Practice for dosimetry in an electron
beam facility for radiation processing
at energies between 80 and 300 keV
Pratique de la dosimétrie dans une installation de traitement par
irradiation utilisant un faisceau d'électrons d'énergies comprises
entre 80 et 300 keV
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: +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. 1
2 Referenced documents. 2
3 Terminology. 2
4 Significance and use. 3
5 Selection and calibration of the dosimetry system. 3
6 Installation and operational qualification. 4
7 Performance qualification. 5
8 Routine process control. 5
9 Measurement uncertainty. 5
10 Documentation. 5
11 Keywords. 6
Annexes. 6
Figure A1.1 Example of measurement of dose as function of average beam currentI, conveying
speedV and beam widthW . Measured at an electron accelerator with beam energy 110 keV.
b
K = 216.57 (kGy · m ) / (A · s). 7
Figure A1.2 Example of beam width measurement (3 measurements and their average are
shown). Beam width was measured on a low-energy accelerator installed in an electron beam
tunnel for an aseptic filling line (3). 7
Figure A1.3 Exampleofbeamwidthmeasurementatalow-energyelectronacceleratorfacilityfor
curing purpose. 8
-3
Figure A1.4 Calculated depth-dose distribution in water (specific density1gcm ). 8
-3
Figure A1.5 Calculated depth-dose distribution in water (specific density1gcm ). 9
Figure A1.6 Methods for measurement of depth-dose distribution. 9
Figure A1.7 Examples of measurements of depth-dose distributions at the same electron beam
facility, but at different beam energies. 10
Figure A2.1 Apparent dose measured with three dosimeters (18 µm RCD film dosimeter (1.12 g
-3 -3 -3
cm ); 50 µm RCD film dosimeter (1.15 g cm ); 130 µm alanine film dosimeter (1.36 g cm ) all
calibrated by irradiation at a 10 MeV electron accelerator, and now irradiated at a 116 keV
electron accelerator. . 11
© 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 E1818‐96), 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”.
This fourth edition cancels and replaces the third edition (ISO/ASTM 51818:2013), which has been
technically revised.
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 an Electron Beam Facility for Radiation
Processing at Energies Between 80 and 300 keV
This standard is issued under the fixed designation ISO/ASTM 51818; the number immediately following the designation indicates the
year of original adoption or, in the case of revision, the year of last revision.
INTRODUCTION
Low energy electron beams, typically 80 – 300 keV, are used in several industrial processes, from
curing of prints and crosslinking of plastic foils to surface sterilization of containers for pharmaceu-
ticals and medical devices.These different applications are addressed through IQ, OQ, PQ and routine
dose monitoring, although radiation curing and crosslinking might only require that reproducibility of
dose delivery during execution of the process can be demonstrated.
This standard practice describes the dose measurements that might be required for full documen-
tation of a low energy electron beam sterilization process. The dose measurement requirements for
sterilization using low energy electron beams are derived from the international standard for radiation
sterilization ISO 11137-1.
Not all low energy e-beam applications require dose measurement documentation with traceability
to national standards. For radiation curing or crosslinking processes, for example, it might not be a
requirement that calibration of the dosimetry system is established and maintained with traceability to
national or international standards. The user must decide whether or not measurement traceability is
required for the specific irradiation process, and it is the user who therefore accepts responsibility for
reproducibility and documentation of the process.
1. Scope 1.4 Other specific ISO and ASTM standards exist for the
irradiation of food and the radiation sterilization of health care
1.1 This practice covers dosimetric procedures to be fol-
products. For the radiation sterilization of health care products,
lowedininstallationqualification,operationalqualificationand
see ISO 11137-1. In those areas covered by ISO 11137-1, that
performance qualification (IQ, OQ, PQ), and routine process-
standard takes precedence. For food irradiation, see ISO
ing at electron beam facilities to ensure that the product has
14470.Informationabouteffectiveorregulatorydoselimitsfor
been treated with an acceptable range of absorbed doses. Other
food products is not within the scope of this practice (see
procedures related to IQ, OQ, PQ, and routine product pro-
cessing that may influence absorbed dose in the product are ASTM F1355 and F1356).
also discussed.
This document is one of a set of standards that provides
1.5
1.2 The electron beam energy range covered in this practice
recommendations for properly implementing dosimetry in
is between 80 and 300 keV, generally referred to as low energy.
radiation processing, and describes a means of achieving
1.3 Dosimetry is only one component of a total quality
compliance with the requirements of ISO/ASTM 52628.Itis
assurance program for an irradiation facility. Other measures
intended to be read in conjunction with ISO/ASTM 52628.
may be required for specific applications such as medical
1.6 This standard does not purport to address all of the
device sterilization and food preservation.
safety concerns, if any, associated with its use. It is the
responsibility of the user of this standard to establish appro-
This practice is under the jurisdiction of ASTM Committee E61 on Radiation
priate safety, health, and environmental practices and deter-
Processing and is the direct responsibility of Subcommittee E61.03 on Dosimetry
mine the applicability of regulatory limitations prior to use.
Application, and is also under the jurisdiction of ISO/TC 85/WG 3.
Current edition approved March 2020. Published June 2020. Originally pub-
1.7 This international standard was developed in accor-
lished as ASTM E1818–96. The present Fourth Edition of International Standard
dance with internationally recognized principles on standard-
51818:2013(E). ization established in the Decision on Principles for the
© ISO/ASTM International 2020 – All rights reserved
Development of International Standards, Guides and Recom- 17025:2017 General requirements for the competence of
mendations issued by the World Trade Organization Technical testing and calibration laboratories
Barriers to Trade (TBT) Committee. 12749-4 Nuclear energy, nuclear technologies, and radio-
logical protection – Vocabulary – Part 4: Dosimetry for
2. Referenced documents
radiation processing
2.5 Joint Committee for Guides in Metrology (JCGM)
2.1 ASTM Standards:
E2232 Guide for Selection and Use of Mathematical Meth- Reports:
JCGM 100:2008, GUM 1995, with minor corrections,
ods for Calculating Absorbed Dose in Radiation Process-
ing Applications Evaluation of measurement data – Guide to the expression
of uncertainty in measurement
E3083 Terminology Relating to Radiation Processing: Do-
simetry and Applications JCGM 200:2012, VIM International vocabulary of metrol-
ogy – Basic and general concepts and associated terms
F1355 GuideforIrradiationofFreshAgriculturalProduceas
a Phytosanitary Treatment
3. Terminology
F1356 Guide for Irradiation of Fresh, Frozen or Processed
Meat and Poultry to Control Pathogens and Other Micro- 3.1 Definitions:
organisms
3.1.1 absorbed dose (D)—quotient of dε¯ by dm, where dε¯ is
2.2 ISO/ASTM Standards: the mean energy imparted by ionizing radiation to matter of
51261 Practice for Calibration of Routine Dosimetry Sys- incremental mass dm (ICRU-85a), thus
tems for Radiation Processing
D 5 dε¯⁄dm
51275 Practice for Use of a Radiochromic Film Dosimetry
3.1.1.1 Discussion—TheSIunitofabsorbeddoseisthegray
System
(Gy),where1grayisequivalenttotheabsorptionof1jouleper
51607 Practice for Use of an Alanine-EPR Dosimetry Sys-
kilogram of the specified material (1 Gy=1J/ kg).
tem
3.1.1.2 Discussion—Throughout this practice, “absorbed
51649 Practice for Dosimetry in an Electron Beam Facility
dose” is referred to as “dose”.
forRadiationProcessingatEnergiesbetween300keVand
3.1.2 approved laboratory—laboratory that is a recognized
25 MeV
national metrology institute; or has been formally accredited to
51650 Practice for Use of a Cellulose Triacetate Dosimetry
ISO/IEC 17025; or has a quality system consistent with the
System
requirements of ISO/IEC 17025.
51707 Guide for Estimating Uncertainties in Dosimetry for
3.1.3 average beam current—time-averaged electr
...
INTERNATIONAL ISO/ASTM
STANDARD 51818
Fourth edition
2020-06
Practice for dosimetry in an electron
beam facility for radiation processing
at energies between 80 and 300 keV
Pratique de la dosimétrie dans une installation de traitement par
irradiation utilisant un faisceau d'électrons d'énergies comprises
entre 80 et 300 keV
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: +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. 1
2 Referenced documents. 2
3 Terminology. 2
4 Significance and use. 3
5 Selection and calibration of the dosimetry system. 3
6 Installation and operational qualification. 4
7 Performance qualification. 5
8 Routine process control. 5
9 Measurement uncertainty. 5
10 Documentation. 5
11 Keywords. 6
Annexes. 6
Figure A1.1 Example of measurement of dose as function of average beam currentI, conveying
speedV and beam widthW . Measured at an electron accelerator with beam energy 110 keV.
b
K = 216.57 (kGy · m ) / (A · s). 7
Figure A1.2 Example of beam width measurement (3 measurements and their average are
shown). Beam width was measured on a low-energy accelerator installed in an electron beam
tunnel for an aseptic filling line (3). 7
Figure A1.3 Exampleofbeamwidthmeasurementatalow-energyelectronacceleratorfacilityfor
curing purpose. 8
-3
Figure A1.4 Calculated depth-dose distribution in water (specific density1gcm ). 8
-3
Figure A1.5 Calculated depth-dose distribution in water (specific density1gcm ). 9
Figure A1.6 Methods for measurement of depth-dose distribution. 9
Figure A1.7 Examples of measurements of depth-dose distributions at the same electron beam
facility, but at different beam energies. 10
Figure A2.1 Apparent dose measured with three dosimeters (18 µm RCD film dosimeter (1.12 g
-3 -3 -3
cm ); 50 µm RCD film dosimeter (1.15 g cm ); 130 µm alanine film dosimeter (1.36 g cm ) all
calibrated by irradiation at a 10 MeV electron accelerator, and now irradiated at a 116 keV
electron accelerator. . 11
© 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 E1818‐96), 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”.
This fourth edition cancels and replaces the third edition (ISO/ASTM 51818:2013), which has been
technically revised.
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 an Electron Beam Facility for Radiation
Processing at Energies Between 80 and 300 keV
This standard is issued under the fixed designation ISO/ASTM 51818; the number immediately following the designation indicates the
year of original adoption or, in the case of revision, the year of last revision.
INTRODUCTION
Low energy electron beams, typically 80 – 300 keV, are used in several industrial processes, from
curing of prints and crosslinking of plastic foils to surface sterilization of containers for pharmaceu-
ticals and medical devices.These different applications are addressed through IQ, OQ, PQ and routine
dose monitoring, although radiation curing and crosslinking might only require that reproducibility of
dose delivery during execution of the process can be demonstrated.
This standard practice describes the dose measurements that might be required for full documen-
tation of a low energy electron beam sterilization process. The dose measurement requirements for
sterilization using low energy electron beams are derived from the international standard for radiation
sterilization ISO 11137-1.
Not all low energy e-beam applications require dose measurement documentation with traceability
to national standards. For radiation curing or crosslinking processes, for example, it might not be a
requirement that calibration of the dosimetry system is established and maintained with traceability to
national or international standards. The user must decide whether or not measurement traceability is
required for the specific irradiation process, and it is the user who therefore accepts responsibility for
reproducibility and documentation of the process.
1. Scope 1.4 Other specific ISO and ASTM standards exist for the
irradiation of food and the radiation sterilization of health care
1.1 This practice covers dosimetric procedures to be fol-
products. For the radiation sterilization of health care products,
lowedininstallationqualification,operationalqualificationand
see ISO 11137-1. In those areas covered by ISO 11137-1, that
performance qualification (IQ, OQ, PQ), and routine process-
standard takes precedence. For food irradiation, see ISO
ing at electron beam facilities to ensure that the product has
14470.Informationabouteffectiveorregulatorydoselimitsfor
been treated with an acceptable range of absorbed doses. Other
food products is not within the scope of this practice (see
procedures related to IQ, OQ, PQ, and routine product pro-
cessing that may influence absorbed dose in the product are ASTM F1355 and F1356).
also discussed.
This document is one of a set of standards that provides
1.5
1.2 The electron beam energy range covered in this practice
recommendations for properly implementing dosimetry in
is between 80 and 300 keV, generally referred to as low energy.
radiation processing, and describes a means of achieving
1.3 Dosimetry is only one component of a total quality
compliance with the requirements of ISO/ASTM 52628.Itis
assurance program for an irradiation facility. Other measures
intended to be read in conjunction with ISO/ASTM 52628.
may be required for specific applications such as medical
1.6 This standard does not purport to address all of the
device sterilization and food preservation.
safety concerns, if any, associated with its use. It is the
responsibility of the user of this standard to establish appro-
This practice is under the jurisdiction of ASTM Committee E61 on Radiation
priate safety, health, and environmental practices and deter-
Processing and is the direct responsibility of Subcommittee E61.03 on Dosimetry
mine the applicability of regulatory limitations prior to use.
Application, and is also under the jurisdiction of ISO/TC 85/WG 3.
Current edition approved March 2020. Published June 2020. Originally pub-
1.7 This international standard was developed in accor-
lished as ASTM E1818–96. The present Fourth Edition of International Standard
dance with internationally recognized principles on standard-
51818:2013(E). ization established in the Decision on Principles for the
© ISO/ASTM International 2020 – All rights reserved
Development of International Standards, Guides and Recom- 17025:2017 General requirements for the competence of
mendations issued by the World Trade Organization Technical testing and calibration laboratories
Barriers to Trade (TBT) Committee. 12749-4 Nuclear energy, nuclear technologies, and radio-
logical protection – Vocabulary – Part 4: Dosimetry for
2. Referenced documents
radiation processing
2.5 Joint Committee for Guides in Metrology (JCGM)
2.1 ASTM Standards:
E2232 Guide for Selection and Use of Mathematical Meth- Reports:
JCGM 100:2008, GUM 1995, with minor corrections,
ods for Calculating Absorbed Dose in Radiation Process-
ing Applications Evaluation of measurement data – Guide to the expression
of uncertainty in measurement
E3083 Terminology Relating to Radiation Processing: Do-
simetry and Applications JCGM 200:2012, VIM International vocabulary of metrol-
ogy – Basic and general concepts and associated terms
F1355 GuideforIrradiationofFreshAgriculturalProduceas
a Phytosanitary Treatment
3. Terminology
F1356 Guide for Irradiation of Fresh, Frozen or Processed
Meat and Poultry to Control Pathogens and Other Micro- 3.1 Definitions:
organisms
3.1.1 absorbed dose (D)—quotient of dε¯ by dm, where dε¯ is
2.2 ISO/ASTM Standards: the mean energy imparted by ionizing radiation to matter of
51261 Practice for Calibration of Routine Dosimetry Sys- incremental mass dm (ICRU-85a), thus
tems for Radiation Processing
D 5 dε¯⁄dm
51275 Practice for Use of a Radiochromic Film Dosimetry
3.1.1.1 Discussion—TheSIunitofabsorbeddoseisthegray
System
(Gy),where1grayisequivalenttotheabsorptionof1jouleper
51607 Practice for Use of an Alanine-EPR Dosimetry Sys-
kilogram of the specified material (1 Gy=1J/ kg).
tem
3.1.1.2 Discussion—Throughout this practice, “absorbed
51649 Practice for Dosimetry in an Electron Beam Facility
dose” is referred to as “dose”.
forRadiationProcessingatEnergiesbetween300keVand
3.1.2 approved laboratory—laboratory that is a recognized
25 MeV
national metrology institute; or has been formally accredited to
51650 Practice for Use of a Cellulose Triacetate Dosimetry
ISO/IEC 17025; or has a quality system consistent with the
System
requirements of ISO/IEC 17025.
51707 Guide for Estimating Uncertainties in Dosimetry for
3.1.3 average beam current—time-averaged electr
...
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