Standard Practice for Electron Beam Radiation Processing at Energies Between 300 keV and 25 MeV

SIGNIFICANCE AND USE
4.1 Various products and materials are routinely irradiated at pre-determined doses at electron beam facilities to preserve or modify their characteristics. Dosimetry requirements may vary depending on the radiation process and end use of the product. A partial list of processes where dosimetry may be used is given below.  
4.1.1 Polymerization of monomers and grafting of monomers onto polymers,  
4.1.2 Cross-linking or degradation of polymers,  
4.1.3 Curing of composite materials,  
4.1.4 Sterilization of health care products,  
4.1.5 Disinfection of consumer products,  
4.1.6 Food irradiation (parasite and pathogen control, insect disinfestation, and shelf-life extension),  
4.1.7 Control of pathogens and toxins in drinking water,  
4.1.8 Control of pathogens and toxins in liquid or solid waste,  
4.1.9 Modification of characteristics of semiconductor devices,  
4.1.10 Color enhancement of gemstones and other materials, and  
4.1.11 Research on radiation effects on materials.  
4.2 Dosimetry is used as a means of monitoring the irradiation process.
Note 2: Dosimetry with measurement traceability and known uncertainty is required for regulated radiation processes such as sterilization of health care products (see ISO 11137-1 and Refs (1-36)) and preservation of food (see ISO 14470 and Ref (4)). It may be less important for other processes, such as polymer modification, which may be evaluated by changes in the physical and chemical properties of the irradiated materials. Nevertheless, routine dosimetry may be used to monitor the reproducibility of the treatment process.
Note 3: Measured dose is often characterized as absorbed dose in water. Materials commonly found in single-use disposable medical devices and food are approximately equivalent to water in the absorption of ionizing radiation. Absorbed dose in materials other than water may be determined by applying conversion factors (5, 6).  
4.3 An irradiation process usually requires a minimum ab...
SCOPE
1.1 This practice outlines dosimetric procedures to be followed in installation qualification (IQ), operational qualification (OQ) and performance qualifications (PQ), and routine processing at electron beam facilities.  
1.2 The electron beam energy range covered in this practice is between 300 keV and 25 MeV, although there are some discussions for other energies.  
1.3 Dosimetry is only one component of a total quality assurance program for adherence to good manufacturing practices used in radiation processing applications. Other measures besides dosimetry may be required for specific applications such as health care product sterilization and food preservation.  
1.4 Specific standards exist for the radiation sterilization of health care products and the irradiation of food. For the radiation sterilization of health care products, see ISO 11137-1 (Requirements) and ISO 11137-3 (Guidance on dosimetric aspects). For irradiation of food, see ISO 14470. In those areas covered by these standards, they take precedence. Information about effective or regulatory dose limits for food products is not within the scope of this practice (see ASTM Guides F1355, F1356, F1736, and F1885).  
1.5 This document is one of a set of standards that provides recommendations for properly implementing and utilizing dosimetry in radiation processing. It is intended to be read in conjunction with ISO/ASTM 52628, “Practice for Dosimetry in Radiation Processing”.
Note 1: For guidance in the calibration of routine dosimetry systems, see ISO/ASTM Practice 51261. For further guidance in the use of specific dosimetry systems, see relevant ISO/ASTM Practices. For discussion of radiation dosimetry for pulsed radiation, see ICRU Report 34.  
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 env...

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Publication Date
30-Nov-2022
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Standards Content (Sample)

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: 51649 − 22
Standard Practice for
Electron Beam Radiation Processing at Energies Between
1
300 keV and 25 MeV
This standard is issued under the fixed designation 51649; 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.
1. Scope priate safety, health, and environmental practices and deter-
mine the applicability of regulatory limitations prior to use.
1.1 This practice outlines dosimetric procedures to be fol-
1.7 This international standard was developed in accor-
lowed in installation qualification (IQ), operational qualifica-
dance with internationally recognized principles on standard-
tion (OQ) and performance qualifications (PQ), and routine
ization established in the Decision on Principles for the
processing at electron beam facilities.
Development of International Standards, Guides and Recom-
1.2 The electron beam energy range covered in this practice
mendations issued by the World Trade Organization Technical
is between 300 keV and 25 MeV, although there are some
Barriers to Trade (TBT) Committee.
discussions for other energies.
2. Referenced documents
1.3 Dosimetry is only one component of a total quality
2
assurance program for adherence to good manufacturing prac-
2.1 ASTM Standards:
tices used in radiation processing applications. Other measures
E2232 Guide for Selection and Use of Mathematical Meth-
besides dosimetry may be required for specific applications
ods for Calculating Absorbed Dose in Radiation Process-
such as health care product sterilization and food preservation.
ing Applications
E2303 Guide for Absorbed-Dose Mapping in Radiation
1.4 Specific standards exist for the radiation sterilization of
Processing Facilities
health care products and the irradiation of food. For the
E3083 Terminology Relating to Radiation Processing: Do-
radiation sterilization of health care products, see ISO 11137-1
simetry and Applications
(Requirements) and ISO 11137-3 (Guidance on dosimetric
F1355 Guide for Irradiation of Fresh Agricultural Produce as
aspects). For irradiation of food, see ISO 14470. In those areas
a Phytosanitary Treatment
covered by these standards, they take precedence. Information
F1356 Guide for Irradiation of Fresh, Frozen or Processed
about effective or regulatory dose limits for food products is
Meat and Poultry to Control Pathogens and Other Micro-
not within the scope of this practice (see ASTM Guides F1355,
organisms
F1356, F1736, and F1885).
F1736 Guide for Irradiation of Finfish and Aquatic Inverte-
1.5 This document is one of a set of standards that provides
brates Used as Food to Control Pathogens and Spoilage
recommendations for properly implementing and utilizing
Microorganisms
dosimetry in radiation processing. It is intended to be read in
F1885 Guide for Irradiation of Dried Spices, Herbs, and
conjunction with ISO/ASTM 52628, “Practice for Dosimetry
Vegetable Seasonings to Control Pathogens and Other
in Radiation Processing”.
Microorganisms
NOTE 1—For guidance in the calibration of routine dosimetry systems,
2
see ISO/ASTM Practice 51261. For further guidance in the use of specific
2.2 ISO/ASTM Standards:
dosimetry systems, see relevant ISO/ASTM Practices. For discussion of
51261 Practice for Calibration of Routine Dosimetry Sys-
radiation dosimetry for pulsed radiation, see ICRU Report 34.
tems for Radiation Processing
1.6 This standard does not purport to address all of the
51275 Practice for Use of a Radiochromic Film Dosimetry
safety concerns, if any, associated with its use. It is the
System
responsibility of the user of this standard to establish appro-
51539 Guide for the Use of Radiation-Sensitive Indicators
51608 Practice for Dosimetry in an X-Ray (Bremsstrahlung)
Facility for Radiation Processing
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. 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 Dec. 1, 2022. Published May 2024. Originally www.astm.org, or contact ASTM Customer Service at service@astm.org. For
approved in 1994. Last previous edition approved in 2015 as ISO/ASTM Annual Book of ASTM Standards volume information, refer to the standard’s
51649:2015(E). DOI: 10.1520/51649-22. Document Summary page on the ASTM website.
Copyright © ASTM I
...

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 51649 − 2015(E) 51649 − 22
Standard Practice for
Dosimetry in an Electron Beam Facility for Radiation
1
Processing at Energies Between 300 keV and 25 MeV
This standard is issued under the fixed designation ISO/ASTM 51649; 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.
1. Scope
1.1 This practice outlines dosimetric procedures to be followed in installation qualification (IQ), operational qualification (OQ)
and performance qualifications (PQ), and routine processing at electron beam facilities.
1.2 The electron beam energy range covered in this practice is between 300 keV and 25 MeV, although there are some discussions
for other energies.
1.3 Dosimetry is only one component of a total quality assurance program for adherence to good manufacturing practices used
in radiation processing applications. Other measures besides dosimetry may be required for specific applications such as health care
product sterilization and food preservation.
1.4 Specific standards exist for the radiation sterilization of health care products and the irradiation of food. For the radiation
sterilization of health care products, see ISO 11137-1 (Requirements) and ISO 11137-3 (Guidance on dosimetric aspects). For
irradiation of food, see ISO 14470. In those areas covered by these standards, they take precedence. Information about effective
or regulatory dose limits for food products is not within the scope of this practice (see ASTM Guides F1355, F1356, F1736, and
F1885).
1.5 This document is one of a set of standards that provides recommendations for properly implementing and utilizing dosimetry
in radiation processing. It is intended to be read in conjunction with ISO/ASTM 52628, “Practice for Dosimetry in Radiation
Processing”.
NOTE 1—For guidance in the calibration of routine dosimetry systems, see ISO/ASTM Practice 51261. For further guidance in the use of specific
dosimetry systems, see relevant ISO/ASTM Practices. For discussion of radiation dosimetry for pulsed radiation, see ICRU Report 34.
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.
1.7 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.
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 . Originally developed as a joint ASTM/ISO standard in conjunction with ISO/TC 85/WG 3.
Current edition approved Dec. 1, 2022Sept. 8, 2014. . Published May 2024February 2015. Originally published as E 1649–94. Last previous ASTM edition E 1649–00.
ε1
ASTM E 1649–94. Originally approved in 1994. Last previous edition approved was adopted by ISO in 1998 with the intermediate designation ISO 15569:1998(E). The
present International Standard ISO/ASTM 51649:2015(E) is a major revision of the last previous edition ISO/ASTM 51649:2005(E), which replaced ISO/ASTM
51649:2002(E).in 2015 as ISO/ASTM 51649:2015(E). DOI: 10.1520/51649-22.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

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51649 − 22
2. Referenced documents
2
2.1 ASTM Standards:
E170 Terminology Relating to Radiation Measurements and Dosimetry
E2232 Guide for Selection and Use of Mathematical Methods for Calculating Absorbed Dose in Radiation Processing
Applications
E2303 Guide for Absorbed-Dose Mapping in Radiation Processing Facilities
E3083 Terminology Relating to Radiation Processing: Dosimetry and Applications
F1355 Guide for Irradiation of Fresh Agricultural Produce as a Phytosanitary Treatment
F1356 Guide for Irradiation of Fresh, Frozen or Processed Meat and Poultry to Control Pathogens and Other Microorganisms
F1
...

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