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ASTM E2628-09

(Practice)

Standard Practice for Dosimetry for Radiation Processing

Standard Practice for Dosimetry for Radiation Processing

SIGNIFICANCE AND USE
Radiation processing of articles in both commercial and research applications may be carried out for a number of purposes. These include, for example, sterilization of health care products, reduction of the microbial populations in foods and modification of polymers. The radiations used may be accelerated electrons, gamma-radiation from radionuclide sources such as cobalt-60, or X-radiation.
To demonstrate control of the radiation process, the absorbed dose must be measured using a dosimetry system, the calibration of which, is traceable to appropriate national or international standards. The radiation-induced change in the dosimeter is evaluated and related to absorbed dose through calibration. Dose measurements required for particular processes are described in other standards referenced in this practice.
SCOPE
1.1 This practice describes the basic requirements that apply when making absorbed dose measurements in accordance with the ASTM E10.01 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.
1.2 This practice applies to dosimetry for radiation processing applications using electrons or photons (gamma- or X-radiation).
1.3 This practice addresses the minimum requirements of a measurement management system, but does not include general quality system requirements.
1.4 This practice does not address personnel dosimetry or medical dosimetry.
1.5 This practice does not apply to primary standard dosimetry systems.
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 health practices and determine the applicability of regulatory limitations prior to use.

General Information

Status
Historical
Publication Date
14-Aug-2009
ICS
17.240 - Radiation measurements
Technical Committee
E61 - Radiation Processing
Drafting Committee
E61.01 - Dosimetry
Current Stage
Ref Project

Relations

Referred By
ASTM ISO/ASTM52116-13(2020) - Standard Practice for Dosimetry for a Self-Contained Dry-Storage Gamma Irradiator
Effective Date
15-Aug-2009
Referred By
ASTM ISO/ASTM51261-13(2020) - Standard Practice for Calibration of Routine Dosimetry Systems for Radiation Processing
Effective Date
15-Aug-2009
Referred By
ASTM ISO/ASTM51607-13 - Standard Practice for Use of the Alanine-EPR Dosimetry System
Effective Date
15-Aug-2009
Referred By
ASTM ISO/ASTM51275-13 - Standard Practice for Use of a Radiochromic Film Dosimetry System
Effective Date
15-Aug-2009
Referred By
ASTM ISO/ASTM51702-13(2021) - Standard Practice for Dosimetry in a Gamma Facility for Radiation Processing
Effective Date
15-Aug-2009
Referred By
ASTM ISO/ASTM51650-13 - Standard Practice for Use of a Cellulose Triacetate Dosimetry System
Effective Date
15-Aug-2009

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ASTM E2628-09 - Standard Practice for Dosimetry for Radiation ProcessingASTM E2628-09 - Standard Practice for Dosimetry for Radiation Processing
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ASTM E2628-09 - Standard Practice for Dosimetry for Radiation Processing
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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information.
An American National Standard
Designation: E2628 – 09
Standard Practice for
Dosimetry for Radiation Processing
This standard is issued under the fixed designation E2628; 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
The use of ionizing radiation for the treatment of commercial products such as the sterilization of
medical devices, 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.
It is necessary to ensure that the specified absorbed dose is applied in each of the radiation
processing applications. 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 has under its jurisdiction
approximately 30 standard practices and standard guides, collectively known as the E10.01 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.Acurrent list of the E10.01 standards
on radiation processing is given in 2.1 and 2.2.
The development, validation and routine control of a radiation process comprises 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 is known, including the effect of influence quantities. The E10.01 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. Practice E2628 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 Practice E2628 for the general requirements.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
E2628 – 09
1. Scope F1736 Guide for Irradiation of Finfish andAquatic Inverte-
brates Used as Food to Control Pathogens and Spoilage
1.1 Thispracticedescribesthebasicrequirementsthatapply
Microorganisms
when making absorbed dose measurements in accordance with
F1885 Guide for Irradiation of Dried Spices, Herbs, and
theASTM E10.01 series of dosimetry standards. In addition, it
Vegetable Seasonings to Control Pathogens and Other
provides guidance on the selection of dosimetry systems and
Microorganisms
directs the user to other standards that provide specific infor-
2.2 ISO/ASTM Standards:
mation on individual dosimetry systems, calibration methods,
51204 Practice for Dosimetry in Gamma Irradiation Facili-
uncertainty estimation and radiation processing applications.
ties for Food Processing
1.2 This practice applies to dosimetry for radiation process-
ing applications using electrons or photons (gamma- or 51205 PracticeforUseofaCeric-CerousSulfateDosimetry
X-radiation).
System
1.3 This practice addresses the minimum requirements of a
51261 Guide for Selection and Calibration of Dosimetry
measurement management system,butdoesnotincludegeneral
Systems for Radiation Processing
quality system requirements.
51275 Practice for the Use of a Radiochromic Film Dosim-
1.4 This practice does not address personnel dosimetry or
etry System
medical dosimetry.
51276 Practice for the Use of a Polymethylmethacrylate
1.5 This practice does not apply to primary standard dosim-
Dosimetry System
etry systems.
51310 Practice for the Use of a Radiochromic Optical
1.6 This standard does not purport to address all of the
Waveguide Dosimetry System
safety concerns, if any, associated with its use. It is the
51401 Practice for Use of a Dichromatic Dosimetry System
responsibility of the user of this standard to establish appro-
priate safety and health practices and determine the applica-
51431 Practice for Dosimetry in Electron Beam and X-Ray
bility of regulatory limitations prior to use. (Bremsstrahlung) Irradiation Facilities for Food Process-
ing
2. Referenced Documents
51538 Practice for Use of the Ethanol-Chlorobenzene Do-
2.1 ASTM Standards:
simetry System
E170 TerminologyRelatingtoRadiationMeasurementsand
51540 Practice for Use of a Radiochromic Liquid Dosim-
Dosimetry
etry System
E1026 Practice for Using the Fricke Reference-Standard
51607 Practice for Use of the Alanine-EPR Dosimetry
Dosimetry System
System
E2232 Guide for Selection and Use of Mathematical Meth-
51608 Practice for Dosimetry in an X-Ray (Bremmstrahl-
odsforCalculatingAbsorbedDoseinRadiationProcessing
ung) Facility for Radiation Processing
Applications
E2303 Guide for Absorbed-Dose Mapping in Radiation 51631 Practice for Use of Calorimetric Dosimetry Systems
Processing Facilities for Electron Beam Dose Measurements and Routine
E2304 Practice for Use of a LiF Photo-Fluorescent Film Dosimeter Calibration
Dosimetry System
51649 Practice for Dosimetry in an Electron-Beam Facility
E2381 Guide for Dosimetry In Radiation Processing of
for Radiation Processing at Energies Between 300 keV
Fluidized Beds and Fluid Streams
and 25 MeV
E2449 Guide for Irradiation of Pre-packaged Processed
51650 Practice for Use of Cellulose Triacetate Dosimetry
Meat and Poultry Products to Control Pathogens and Other
Systems
Microorganisms
51702 Practice for Dosimetry in a Gamma Irradiation Fa-
E2701 Guide for Performance Characterization of Dosim-
cility for Radiation Processing
etersandDosimetrySystemsforUseinRadiationProcess-
51707 Guide for Estimating Uncertainties in Dosimetry for
ing
Radiation Processing
F1355 Guide for Irradiation of Fresh Agricultural Produce
51818 Practice for Dosimetry in an Electron Beam Facility
as a Phytosanitary Treatment
for Radiation Processing at Energies Between 80 and 300
F1356 Practice for Irradiation of Fresh and Frozen Red
keV
Meat and Poultry to Control Pathogens and Other Micro-
51900 Guide for Dosimetry in Radiation Research on Food
organisms
and Agricultural Products
1 51939 Practice for Blood Irradiation Dosimetry
This practice is under the jurisdiction of ASTM Committee E10 on Nuclear
Technology and Applications and is the direct responsibility of Subcommittee
51940 Guide for Dosimetry for Sterile Insect Release Pro-
E10.01 on Radiation Processing: Dosimetry and Applications.
grams
Current edition approved Aug. 15, 2009. Published September 2009. DOI:
10.1520/E2628-09. 51956 Practice for Thermoluminescence-Dosimetry (TLD)
For referenced ASTM and ISO/ASTM standards, visit the ASTM website,
Systems for Radiation Processing
www.astm.org, or contact ASTM Customer Service at service@astm.org. For
52116 Practice for Dosimetry for a Self-Contained Dry-
Annual Book of ASTM Standards volume information, refer to the standard’s
Document Summary page on the ASTM website. Storage Gamma-Ray Irradiator
E2628 – 09
2.3 ISO Standards: 3.1.6 dosimeter response—reproducible,quantifiableradia-
ISO 11137-1 Sterilization of health care products – Radia- tion effect produced in the dosimeter.
tion – Part 1: Requirements for development, validation
3.1.7 dosimetry—measurement of absorbed dose by the use
and routine control of a sterilization process for medical
of a dosimetry system.
devices
3.1.8 dosimetry system—system used for measuring ab-
ISO 11137-3 Sterilization of health care products – Radia-
sorbed dose, consisting of dosimeters, measurement instru-
tion – Part 3: Guidance on dosimetric aspects
ments and their associated reference standards, and procedures
ISO 10012 Measurement managements systems – Require-
for the system’s use.
ments for measurement processes and measuring equip-
3.1.9 influence quantity—quantity that is not the measurand
ment
but that affects the result of the measurement.
ISO 17025 General requirements for the competence of
3.1.10 measurement management system—set of interre-
testing and calibration laboratories
2.4 International Commission on Radiation Units and lated or interacting elements necessary to achieve metrological
Measurements (ICRU) Reports: confirmation and continual control of measurement processes.
ICRU Report 60 Fundamental Quantities and Units for
3.1.11 primary standard dosimetry system —dosimetry sys-
Ionizing Radiation
tem that is designated or widely acknowledged as having the
ICRU Report 80 Dosimetry Systems for Use in Radiation
highest metrological qualities and whose value is accepted
Processing
without reference to other standards of the same quantity.
2.5 ISO Reports:
3.1.12 radiation processing—intentional irradiation of
GUM Guide to the Expression of Uncertainty in Measure-
products or materials to preserve, modify or improve their
ment, 1995
characteristics.
VIM International Vocabulary of Basic and General Terms
3.1.13 reference standard dosimetry system—dosimetry
in Metrology, 1993
system, generally having the highest metrological quality
available at a given location or in a given organization, from
3. Terminology
which measurements made there are derived.
3.1 Definitions:
3.1.14 reference standard radiation field—calibrated radia-
3.1.1 absorbed dose—quantity of ionizing radiation energy
tion field, generally having the highest metrological quality
imparted per unit mass of a specified material. The SI unit of
available at a given location or in a given organization, from
absorbed dose is the gray (Gy), where 1 gray is equivalent to
which measurements made there are derived.
the absorption of 1 joule per kilogram of the specified material
(1 Gy = 1 J/kg). The mathematical relationship is the quotient 3.1.15 response function—mathematical representation of
– –
therelationshipbetweendosimeterresponseandabsorbeddose
of d´by dm,where d´isthemeanincrementalenergyimparted
for a given dosimetry system.
by ionizing radiation to matter of incremental mass dm.
3.1.16 routine dosimetry system—dosimetry system cali-
3.1.2 accredited dosimetry calibration laboratory—
brated against a reference standard dosimetry system and used
dosimetry laboratory with formal recognition by an accrediting
for routine absorbed dose measurements, including dose map-
organization that the dosimetry laboratory is competent to
carry out specific activities which lead to the calibration or ping and process monitoring.
calibration verification of dosimetry systems in accordance
3.1.17 traceability—propertyoftheresultofameasurement
with documented requirements of the accrediting organization.
or the value of a standard whereby it can be related to stated
3.1.3 calibration—set of operations that establish, under
references, usually national or international standards, through
specified conditions, the relationship between values of quan-
an unbroken chain of comparisons all having stated uncertain-
tities indicated by a measuring instrument or measuring sys-
ties.
tem,orvaluesrepresentedbyamaterialmeasureorareference
3.1.18 transfer standard dosimetry system—dosimetry sys-
material, and the corresponding values realized by standards.
tem used as an intermediary to calibrate other dosimetry
3.1.4 dosimeter—device that, when irradiated, exhibits a
systems.
quantifiable change that can be related to absorbed dose in a
3.1.19 type I dosimeter—dosimeter of high metrological
given material using appropriate measurement instruments and
quality, the response of which is affected by individual influ-
procedures.
ence quantities in a well-defined way that can be expressed in
3.1.5 dosimeter/dosimetry system characterization
terms of independent correction factors.
—determination of performance characteristics, such as dose
3.1.19.1 Discussion—See Section 6 for examples and fur-
range, reproducibility and the effect of influence quantities, for
ther details.
a dosimeter/dosimetry system under defined test conditions.
3.1.20 type II dosimeter—dosimeter, the response of which
isaffectedbyinfluencequantitiesinacomplexwaythatcannot
practically be expressed in terms of independent correction
Available from International Organization for Standardization (ISO), 1, ch. de
la Voie-Creuse, Case postale 56, CH-1211, Geneva 20, Switzerland, http://
factors.
www.iso.ch.
4 3.1.20.1 Discussion—See Section 6 for examples and fur-
Available from the International Commission on Radiation Units and Measure-
ments, 7910 Woodmont Ave, Suite 800, Bethesda, MD 20815, USA. ther details.
...

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4.1 The Fricke dosimetry system provides a reliable means for measurement of absorbed dose to water, based on a process of oxidation of ferrous ions to ferric ions in acidic aqueous solution by ionizing radiation (ICRU 80, PIRS-0815, (4)). In situations not requiring traceability to national standards, this system can be used for absolute determination of absorbed dose without calibration, as the radiation chemical yield of ferric ions is well characterized (see Appendix X3).  
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1.3 The practice describes the spectrophotometric analysis procedures for the Fricke dosimetry system.  
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1.5 This practice applies provided the following are satisfied:  
1.5.1 The absorbed dose range shall be from 20 Gy to 400 Gy (1).2  
1.5.2 The absorbed dose rate does not exceed 106 Gy·s−1 (2).  
1.5.3 For radioisotope gamma sources, the initial photon energy is greater than 0.6 MeV. For X-radiation (bremsstrahlung), the initial energy of the electrons used to produce the photons is equal to or greater than 2 MeV. For electron beams, the initial electron energy is greater than 8 MeV.  
Note 1: The lower energy limits given are appropriate for a cylindrical dosimeter ampoule of 12 mm diameter. Corrections for displacement effects and dose gradient across the ampoule may be required for electron beams (3). The Fricke dosimetry system may be used at lower energies by employing thinner (in the beam direction) dosimeter containers (see ICRU Report 35).  
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Standard Practice for Blood Irradiation Dosimetry

SIGNIFICANCE AND USE
4.1 Blood and blood components are irradiated to predetermined absorbed doses to inactivate viable lymphocytes to help prevent transfusion-induced graft-versus-host disease (GVHD) in certain immunocompromised patients and those receiving related-donor products (1, 2).9  
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4.4 Blood irradiation specifications include a lower limit of absorbed dose, and may include an upper limit or central target dose. For a given application, any of these values may be prescribed by regulations that have been established on the basis of available scientific data (see 2.6).  
4.5 For each blood irradiator, an absorbed-dose rate at a reference position within the canister is measured as part of irradiator acceptance testing using a reference-standard dosimetry system. That reference-standard measurement is used to establish operating parameters so as to deliver specified dose to blood and blood components.  
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1.1 This practice outlines the irradiator installation qualification program and the dosimetric procedures to be followed during operational qualification and performance qualification of the irradiator. Procedures for the routine radiation processing of blood product (blood and blood components) are also given. If followed, these procedures will help ensure that blood product exposed to gamma radiation or X-radiation (bremsstrahlung) will receive absorbed doses with a specified range.  
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1.3 The photon energy range of X-radiation used for blood irradiation is typically from 40 keV to 300 keV.  
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4.1 Standards such as ISO 11137-1 (radiation sterilization of health care products) and ISO 14470 (irradiation of food) contain requirements that dosimetry used in the development, validation, and routine control of the process shall have measurement traceability to national or international standards and shall have a known level of uncertainty. The magnitude of the measurement uncertainty is important for assessing the results of the measurement system.  
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SIGNIFICANCE AND USE
4.1 A variety of products and materials are irradiated with X-radiation to modify their characteristics and improve the economic value or to reduce their microbial population for health-related purposes. Dosimetry requirements might vary depending on the type and end use of the product. Some examples of irradiation applications where dosimetry may be used are:  
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1.1 This practice outlines the dosimetric procedures to be followed during installation qualification, operational qualification, performance qualification and routine processing at an X-ray (bremsstrahlung) irradiator. Other procedures related to operational qualification, performance qualification and routine processing that may influence absorbed dose in the product are also discussed.
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1.2 For radiation sterilization of health care products, see ISO 11137-1, Sterilization of health care products – Radiation – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices. In those areas covered by ISO 11137-1, that standard takes precedence.  
1.3 For irradiation of food, see ISO 14470, Food irradiation – Requirements for development, validation and routine control of the process of irradiation using ionizing radiation for the treatment of food. In those areas covered by ISO 14470, that standard takes precedence.  
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1.5 In contrast to monoenergetic gamma radiation, the X-ray energy spectrum extends from low values (about 35 keV) up to the maximum energy of the electrons incident on the X-ray target (see Section 5 and Annex A1).  
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ASTM
ASTM ISO/ASTM51649-22(Practice)
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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ASTM
ASTM ISO/ASTM51607-22(Practice)
Standard Practice for Use of an Alanine-EPR Dosimetry System

SIGNIFICANCE AND USE
4.1 The alanine-EPR dosimetry system provides a means for measuring absorbed dose. It is based on the measurement of specific stable free radicals in crystalline alanine generated by ionizing radiation.  
4.2 Alanine-EPR dosimetry systems are used in reference- or transfer-standard or routine dosimetry systems in radiation applications that include: sterilization of medical devices and pharmaceuticals, food irradiation, polymer modifications, medical therapy and radiation damage studies in materials (1, 13-15).
SCOPE
1.1 This practice covers dosimeter materials, instrumentation, and procedures for using the alanine-EPR dosimetry system to measure the absorbed dose in the photon or electron radiation processing of materials. The alanine system is based on electron paramagnetic resonance (EPR) spectroscopy of free radicals derived from the amino acid alanine.2  
1.2 The alanine dosimeter is classified as a type I dosimeter as it is affected by individual influence quantities in a well-defined way that can be expressed in terms of independent correction factors (see ISO/ASTM Practice 52628). The alanine dosimeter may be used in either a reference standard dosimetry system or in a routine dosimetry system.  
1.3 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 “Practice for Dosimetry in Radiation Processing” for alanine dosimetry system. It should be read in conjunction with ISO/ASTM 52628.  
1.4 This practice covers the use of alanine-EPR dosimetry systems under the following conditions:  
1.4.1 The absorbed dose range is between 0.001 kGy and 150 kGy.  
1.4.2 The absorbed dose rate is up to 1 × 102 Gy s-1 for continuous radiation fields and up to 3 × 1010 Gy s-1 for pulsed radiation fields (1-4).3  
1.4.3 The radiation energy for photons and electrons is between 0.1 MeV and 30 MeV (1, 2, 5-8).  
1.4.4 The irradiation temperature is between –78 °C and +70 °C (2, 9-12).  
1.5 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.  
1.6 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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ASTM
ASTM ISO/ASTM51956-21(Practice)
Standard Practice for Use of a Thermoluminescence-Dosimetry System (TLD System) for Radiation Processing

SIGNIFICANCE AND USE
4.1 In radiation processing, TLDs are mainly used in the irradiation of blood products (see ISO/ASTM Practice 51939) and insects for sterile insect release programs (see ISO/ASTM Guide 51940). TLDs may also be used in other radiation processing applications such as the sterilization of medical products, food irradiation, modification of polymers, irradiation of electronic devices, and curing of inks, coatings and adhesives. (See ISO/ASTM Practices 51608, 51649, and 51702.)  
4.2 For radiation processing, the absorbed-dose range of interest is from 1 Gy to 100 kGy. Some TLDs can be used in applications requiring much lower absorbed doses (for example, for personnel dosimetry), but such applications are outside the scope of this practice. Examples of TLDs and applicable dose ranges are given in Table 1. Information on various types of TLDs and their applications can be found in Refs (1-10).7 (A) This table is taken from Ref (6). Ranges are approximate, and may vary with batch. Supralinearity refers to a region where the slope of the response versus dose curve is greater than that for the linear region.  
4.3 Information on other dosimetry systems used for radiation processing can be found in ICRU Report 80.
SCOPE
1.1 This practice covers procedures for the use of thermoluminescence dosimeters (TLDs) to measure the absorbed dose in materials irradiated by photons or electrons in terms of absorbed dose to water. Thermoluminescence-dosimetry systems (TLD systems) are generally used as routine dosimetry systems.  
1.2 The thermoluminescence dosimeter (TLD) is classified as a type II dosimeter on the basis of the complex effect of influence quantities on the dosimeter response. See ISO/ASTM Practice 52628.  
1.3 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 “Practice for Dosimetry in Radiation Processing” for a TLD system. It is intended to be read in conjunction with ISO/ASTM 52628.  
1.4 This practice covers the use of TLD systems under the following conditions:  
1.4.1 The absorbed-dose range is from 1 Gy to 10 kGy.  
1.4.2 The absorbed-dose rate is between 1 × 10-2 and 1 × 1010 Gy s-1.  
1.4.3 The radiation-energy range for photons and electrons is from 0.1 to 50 MeV.  
1.5 This practice does not cover measurements of absorbed dose in materials subjected to neutron irradiation.  
1.6 This practice does not cover procedures for the use of TLDs for determining absorbed dose in radiation-hardness testing of electronic devices or for clinical dosimetry. Procedures for the use of TLDs for radiation-hardness testing are given in ASTM Practice E668. Procedures for use of TLDs in clinical dosimetry are given in ISO 28057.  
1.7 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.  
1.8 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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ASTM ISO/ASTM51275-21(Practice)
Standard Practice for Use of a Radiochromic Film Dosimetry System

SIGNIFICANCE AND USE
4.1 The radiochromic film dosimetry system provides a means for measuring absorbed dose based on radiation-induced change in color using spectrophotometers, densitometers or scanned images.  
4.2 Radiochromic film dosimetry systems are commonly used in industrial radiation processing, for example in the sterilization of medical devices and the irradiation of foods.
SCOPE
1.1 This is a practice for using radiochromic film dosimetry systems to measure absorbed dose in materials irradiated by photons or electrons in terms of absorbed dose to water. Radiochromic film dosimetry systems are generally used as routine dosimetry systems.  
1.2 The radiochromic film dosimeter is classified as a type II dosimeter on the basis of the complex effect of influence quantities (see ISO/ASTM 52628).  
1.3 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 “Practice for Dosimetry in Radiation Processing” for a radiochromic film dosimetry system. It is intended to be read in conjunction with ISO/ASTM 52628.  
1.4 This practice covers the use of radiochromic film dosimetry systems under the following conditions:  
1.4.1 The absorbed dose range is 1 Gy to 150 kGy.  
1.4.2 The absorbed dose rate is 1 × 10-2 to 1 × 1013 Gy·s-1 (1-4).2  
1.4.3 The photon energy range is 0.1 to 50 MeV.  
1.4.4 The electron energy range is 70 keV to 50 MeV.  
1.5 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.  
1.6 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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ASTM
ASTM ISO/ASTM51401-21(Practice)
Standard Practice for Use of a Dichromate Dosimetry System

SIGNIFICANCE AND USE
4.1 The dichromate system provides a reliable means for measuring absorbed dose to water. It is based on a process of reduction of dichromate ions to chromic ions in acidic aqueous solution by ionizing radiation.  
4.2 The dosimeter is a solution containing silver and dichromate ions in perchloric acid in an appropriate container such as a sealed glass ampoule. The solution indicates absorbed dose by a change (decrease) in optical absorbance at a specified wavelength(s) ((3), ICRU Report 80). A calibrated spectrophotometer is used to measure the absorbance.
SCOPE
1.1 This practice covers the preparation, testing, and procedure for using the acidic aqueous silver dichromate dosimetry system to measure absorbed dose to water when exposed to ionizing radiation. The system consists of a dosimeter and appropriate analytical instrumentation. For simplicity, the system will be referred to as the dichromate system. The dichromate dosimeter is classified as a type I dosimeter on the basis of the effect of influence quantities. The dichromate system may be used as either a reference standard dosimetry system or a routine dosimetry system.  
1.2 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 Practice 52628 for the dichromate dosimetry system. It is intended to be read in conjunction with ISO/ASTM Practice 52628.  
1.3 This practice describes the spectrophotometric analysis procedures for the dichromate system.  
1.4 This practice applies only to gamma radiation, X-radiation/bremsstrahlung, and high energy electrons.  
1.5 This practice applies provided the following conditions are satisfied:  
1.5.1 The absorbed dose range is from 2 × 10 3 to 5 × 104 Gy.  
1.5.2 The absorbed dose rate does not exceed 600 Gy/pulse (12.5 pulses per second), or does not exceed an equivalent dose rate of 7.5 kGy/s from continuous sources (1).2  
1.5.3 For radionuclide gamma sources, the initial photon energy shall be greater than 0.6 MeV. For bremsstrahlung photons, the initial energy of the electrons used to produce the bremsstrahlung photons shall be equal to or greater than 2 MeV. For electron beams, the initial electron energy shall be greater than 8 MeV.  
Note 1: The lower energy limits given are appropriate for a cylindrical dosimeter ampoule of 12 mm diameter. Corrections for displacement effects and dose gradient across the ampoule may be required for electron beams (2). The dichromate system may be used at lower energies by employing thinner (in the beam direction) dosimeter containers (see ICRU Report 35).  
1.5.4 The irradiation temperature of the dosimeter shall be above 0 °C and should be below 80 °C.  
Note 2: The temperature coefficient of dosimeter response is known only in the range of 5 to 50 °C (see 5.2). Use outside this range requires determination of the temperature coefficient.  
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. Specific precautionary statements are given in 9.3.  
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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ASTM ISO/ASTM51702-13(2021)(Practice)
Standard Practice for Dosimetry in a Gamma Facility for Radiation Processing

SIGNIFICANCE AND USE
4.1 Various products and materials routinely are irradiated at predetermined doses in gamma irradiation facilities to reduce their microbial population or to modify their characteristics. Dosimetry requirements may vary depending upon the irradiation application and end use of the product. Some examples of irradiation applications where dosimetry may be used are:  
4.1.1 Sterilization of medical devices,  
4.1.2 Treatment of food for the purpose of parasite and pathogen control, insect disinfestation, and shelf life extension,  
4.1.3 Disinfection of consumer products,  
4.1.4 Cross-linking or degradation of polymers and elastomers,  
4.1.5 Polymerization of monomers and grafting of monomers onto polymers,  
4.1.6 Enhancement of color in gemstones and other materials,  
4.1.7 Modification of characteristics of semiconductor devices, and  
4.1.8 Research on materials effects.
Note 3: Dosimetry is required for regulated irradiation processes such as sterilization of medical devices and the treatment of food. It may be less important for other industrial processes, for example, polymer modification, which can be evaluated by changes in the physical and chemical properties of the irradiated materials.  
4.2 An irradiation process usually requires a minimum absorbed dose to achieve the intended effect. There also may be a maximum absorbed dose that the product can tolerate and still meet its functional or regulatory specifications. Dosimetry is essential to the irradiation process since it is used to determine both of these limits and to confirm that the product is routinely irradiated within these limits.  
4.3 The absorbed-dose distribution within the product depends on the overall product dimensions and mass, irradiation geometry, and source activity distribution.  
4.4 Before an irradiation facility can be used, it must be qualified to determine its effectiveness in reproducibly delivering known, controllable absorbed doses. This involves testing the pro...
SCOPE
1.1 This practice outlines the installation qualification program for an irradiator and the dosimetric procedures to be followed during operational qualification, performance qualification, and routine processing in facilities that process products with ionizing radiation from radionuclide gamma sources to ensure that product has been treated within a predetermined range of absorbed dose. Other procedures related to operational qualification, performance qualification, and routine processing that may influence absorbed dose in the product are also discussed.
Note 1: Dosimetry is only one component of a total quality assurance program for adherence to good manufacturing practices used in radiation processing applications.
Note 2: ISO/ASTM Practices 51818 and 51649 describe dosimetric procedures for low and high enery electron beam facilities for radiation processing and ISO/ASTM Practice 51608 describes procedures for X-ray (bremsstrahlung) facilities for radiation processing.  
1.2 For the radiation sterilization of health care products, see ISO 11137-1. In those areas covered by ISO 11137-1, that standard takes precedence.  
1.3 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 ASTM Practice E2628.  
1.4 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.  
1.5 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...

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