ASTM ISO/ASTM51818-20
(Practice)Standard Practice for Dosimetry in an Electron Beam Facility for Radiation Processing at Energies Between 80 and 300 keV
Standard Practice for Dosimetry in an Electron Beam Facility for Radiation Processing at Energies Between 80 and 300 keV
SIGNIFICANCE AND USE
4.1 A variety of irradiation processes use low energy electron beam facilities to modify product characteristics. Dosimetry requirements, the number and frequency of measurements, and record keeping requirements will vary depending on the type and end use of the products being processed. Dosimetry is often used in conjunction with physical, chemical, or biological testing of the product, to help verify specific treatment parameters.
Note 2: In many cases dosimetry results can be related to other quantitative product properties; for example, gel fraction, melt flow, elastic modulus, molecular weight distribution, or degree of cure.
4.2 Radiation processing specifications usually include a minimum or maximum absorbed dose limit, or both. For a given application these limits may be set by government regulation or by limits inherent to the product itself.
4.3 Critical operating parameters must be controlled to obtain reproducible dose distribution in processed materials. The electron beam energy, beam current, beam width and process line speed (conveying speed) affect absorbed dose.
4.4 Before any electron beam facility can be routinely utilized, it must be characterized to determine the relationship between dose to product and the main operating parameters. This involves testing of the process equipment, calibrating the measuring instruments and the dosimetry system, and demonstrating the ability to consistently deliver the required dose within predetermined specifications.
4.5 In order to establish metrological traceability for a dosimetry system and to measure doses with a known level of uncertainty, it is necessary to calibrate the dosimetry system under irradiation conditions that are consistent with those encountered in routine use. For example, a dosimetry system calibration conducted using penetrating gamma radiation or high energy electrons may result in significant dose measurement errors when the dosimetry system is used at low energy electron b...
SCOPE
1.1 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.
1.2 The electron beam energy range covered in this practice is between 80 and 300 keV, generally referred to as low energy.
1.3 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.
1.4 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).
1.5 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.
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 s...
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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.
ISO/ASTM 51818:2020(E)
Standard Practice for
Dosimetry in an Electron Beam Facility for Radiation
1
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.
1.5 This document is one of a set of standards that provides
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-
1
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-
ISO/ASTM 51818:2020(E) is a major revision of the Third Edition of ISO/ASTM
51818:2013(E). ization established in the Decision on Principles for the
© ISO/ASTM International 2020 – All rights reserved
1
---------------------- Page: 1 ----------------------
ISO/ASTM 51818:2020(E)
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: Dosi
...
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.
ISO/ASTM 51818:2013(E)
ISO/ASTM 51818 − 2020(E)
Standard Practice for
Dosimetry in an Electron Beam Facility for Radiation
1
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
1.1 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.
1.2 The electron beam energy range covered in this practice is between 80 and 300 keV, generally referred to as low energy.
1.3 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.
1.4 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 11137.11137-1. In those areas covered by ISO
11137,11137-1, that standard takes precedence. For food irradiation, see ISO 14470:2011.14470. Information about effective or
regulatory dose limits for food products is not within the scope of this practice (see ASTM F1355 and F1356).
1.5 This document is one of a set of standards that provides recommendations for properly implementing and utilizing dosimetry
in radiation processing. processing, and describes a means of achieving compliance with the requirements of ISO/ASTM 52628.
It is intended to be read in conjunction with ASTMISO/ASTM E223252628, “Practice for Dosimetry in Radiation Processing”.
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 safety, health, and healthenvironmental practices and determine the
applicability of regulatory limitations prior to use.
1
This practice 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 ISO/TC 85/WG 3.
ε1
Current edition approved April 9, 2013. March 2020. Published June 2013June 2020. Originally published as ASTM E1818–96. Last previous ASTM edition E1818–96 .
ε1
ASTM E1818–96 was adopted in 1998 with the intermediate designation ISO 15573:1998(E). The present ThirdThe present Fourth Edition of International Standard
ISO/ASTM 51818:2013(E)51818:2020(E) is a major revision of the SecondThird Edition of ISO/ASTM 51818:2009(E). 51818:2013(E).
© ISO/ASTM International 2020 – All rights reserved
1
---------------------- Page: 1 ----------------------
ISO/ASTM 51818:2020(E)
1.7 This international standard was develop
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