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ASTM ISO/ASTM51608-15

(Practice)

Standard Practice for Dosimetry in an X-Ray (Bremsstrahlung) Facility for Radiation Processing at Energies between 50 keV and 7.5 MeV

Standard Practice for Dosimetry in an X-Ray (Bremsstrahlung) Facility for Radiation Processing at Energies between 50 keV and 7.5 MeV

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:  
4.1.1 Sterilization of health care products;  
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 Curing composite material;  
4.1.6 Polymerization of monomers and oligomer and grafting of monomers onto polymers;  
4.1.7 Enhancement of color in gemstones and other materials;  
4.1.8 Modification of characteristics of semiconductor devices; and  
4.1.9 Research on materials effects of irradiation.
Note 3: Dosimetry with measurement traceability and with known measurement uncertainty is required for regulated irradiation processes, such as the sterilization of health care products and treatment of food. Dosimetry may be less important for other industrial processes, such as polymer modification, which can be evaluated by changes in the physical properties of the irradiated materials. Nevertheless, routine dosimetry may be used to monitor the reproducibility of the radiation process.  
4.2 Radiation processing specifications usually include a pair of absorbed-dose limits: a minimum value to ensure the intended beneficial effect and a maximum value that the product can tolerate while still meeting its functional or regulatory specifications. For a given application, one or both of these values may be prescribed by process specifications or regulations. Knowledge of the dose distribution within irradiated material is essential to help meet these requirements. Dosimetry is essential to the radiation process since it i...
SCOPE
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.
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 51649, 51818 and 51702 describe dosimetric procedures for electron beam and gamma facilities for radiation processing.  
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.  
1.4 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 Practice 52628, “Practice for Dosimetry in Radiation Processing”.  
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).  
1.6 Information about effective or regulatory dose limits and energy limits for X-ray applications is not within the scope of this practice.  
1.7 This ...

General Information

Status
Historical
Publication Date
31-Dec-2014
ICS
17.240 - Radiation measurements
Technical Committee
E61 - Radiation Processing
Drafting Committee
E61.03 - Dosimetry Application
Current Stage
Ref Project

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ASTM ISO/ASTM51608-15 - Standard Practice for Dosimetry in an X-Ray (Bremsstrahlung) Facility for Radiation Processing at Energies between 50 keV and 7.5 MeVASTM ISO/ASTM51608-15 - Standard Practice for Dosimetry in an X-Ray (Bremsstrahlung) Facility for Radiation Processing at Energies between 50 keV and 7.5 MeV
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ASTM ISO/ASTM51608-15 - Standard Practice for Dosimetry in an X-Ray (Bremsstrahlung) Facility for Radiation Processing at Energies between 50 keV and 7.5 MeV
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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
ISO/ASTM 51608:2015(E)
Standard Practice for
Dosimetry in an X-Ray (Bremsstrahlung) Facility for
Radiation Processing at Energies between 50 keV and 7.5
1
MeV
This standard is issued under the fixed designation ISO/ASTM 51608; the number immediately following the designation indicates the
year of original adoption or, in the case of revision, the year of last revision.
1. Scope keV) up to the maximum energy of the electrons incident on
the X-ray target (see Section 5 and Annex A1).
1.1 This practice outlines the dosimetric procedures to be
followed during installation qualification, operational
1.6 Informationabouteffectiveorregulatorydoselimitsand
qualification, performance qualification and routine processing
energy limits for X-ray applications is not within the scope of
at an X-ray (bremsstrahlung) irradiator. Other procedures
this practice.
related to operational qualification, performance qualification
1.7 This standard does not purport to address all of the
androutineprocessingthatmayinfluenceabsorbeddoseinthe
safety concerns, if any, associated with its use. It is the
product are also discussed.
responsibility of the user of this standard to establish appro-
NOTE 1—Dosimetry is only one component of a total quality assurance
priate safety and health practices and determine the applica-
program for adherence to good manufacturing practices used in radiation
bility of regulatory limitations prior to use.
processing applications.
NOTE 2—ISO/ASTM Practices 51649, 51818 and 51702 describe
dosimetric procedures for electron beam and gamma facilities for radia-
2. Referenced documents
tion processing.
2
2.1 ASTM Standards:
1.2 For radiation sterilization of health care products, see
E170Terminology Relating to Radiation Measurements and
ISO 11137-1, Sterilization of health care products – Radiation
Dosimetry
– Part 1: Requirements for development, validation and
E2232Guide for Selection and Use of Mathematical Meth-
routine control of a sterilization process for medical devices.In
ods for CalculatingAbsorbed Dose in Radiation Process-
those areas covered by ISO 11137-1, that standard takes
ing Applications
precedence.
E2303Guide for Absorbed-Dose Mapping in Radiation
1.3 Forirradiationoffood,seeISO14470, Food irradiation
Processing Facilities
– Requirements for development, validation and routine con-
2
2.2 ISO/ASTM Standards:
trol of the process of irradiation using ionizing radiation for
51261Practice for Calibration of Routine Dosimetry Sys-
the treatment of food. In those areas covered by ISO 14470,
tems for Radiation Processing
that standard takes precedence.
51539Guide for Use of Radiation-Sensitive Indicators
1.4 This document is one of a set of standards that provides
51649Practice for Dosimetry in an Electron Beam Facility
recommendations for properly implementing and utilizing
for Radiation Processing at Energies Between 300 keV
dosimetry in radiation processing. It is intended to be read in
and 25 MeV
conjunction with ISO/ASTM Practice 52628, “Practice for
51702Practice for Dosimetry in a Gamma Facility for
Dosimetry in Radiation Processing”.
Radiation Processing
51707Guide for Estimating Uncertainties in Dosimetry for
1.5 In contrast to monoenergetic gamma radiation, the
Radiation Processing
X-ray energy spectrum extends from low values (about 35
51818Practice for Dosimetry in an Electron Beam Facility
for Radiation Processing at Energies Between 80and 300
keV
1
This practice is under the jurisdiction of ASTM Committee E61 on Radiation
52628Practice for Dosimetry in Radiation Processing
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.
Current edition approved Sept. 8, 2014. Published February 2015. Originally
published asASTM E 1608–94. Last previousASTM edition E 1608–00.ASTM E
2
1608–94 was adopted by ISO in 1998 with the intermediate designation ISO For referenced ASTM or ISO/ASTM standards, visit the ASTM website,
15567:1998(E). The present International Standard ISO/ASTM 51608:2015(E) is a www.astm.org, or contact ASTM Customer Service at service@astm.org. For
major revision of the last previous edition ISO/ASTM 51608:2005(E), which Annual Book of ASTM Standards volume information, refer to the standard’s
replaced ISO/ASTM 51608:2002(E). Document Summary page on the ASTM website.
© ISO/ASTM International 2022 – All rights reserved
1

---------------------- Page: 1 ----------------------
ISO/ASTM 51608:2015(E)
52701Guide for Performance Characterization of Dosim- 3.1.3 beam width—dimension of the irradiation zone per-
etersandDosimetrySystemsforuseinRadiationProcess- pendiculartothedirectionofproductmovement,ataspecified
ing distance from the accelerator window.
3
3.1.3.1 Discussion—For graphic illustration, see ISO/
2.3 ISO Standards:
AST
...

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ASTM ISO/ASTM51608-15(2022)(Practice)
Standard Practice for Dosimetry in an X-Ray (Bremsstrahlung) Facility for Radiation Processing at Energies between 50 keV and 7.5 MeV

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:  
4.1.1 Sterilization of health care products;  
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 Curing composite material;  
4.1.6 Polymerization of monomers and oligomer and grafting of monomers onto polymers;  
4.1.7 Enhancement of color in gemstones and other materials;  
4.1.8 Modification of characteristics of semiconductor devices; and  
4.1.9 Research on materials effects of irradiation.
Note 3: Dosimetry with measurement traceability and with known measurement uncertainty is required for regulated irradiation processes, such as the sterilization of health care products and treatment of food. Dosimetry may be less important for other industrial processes, such as polymer modification, which can be evaluated by changes in the physical properties of the irradiated materials. Nevertheless, routine dosimetry may be used to monitor the reproducibility of the radiation process.  
4.2 Radiation processing specifications usually include a pair of absorbed-dose limits: a minimum value to ensure the intended beneficial effect and a maximum value that the product can tolerate while still meeting its functional or regulatory specifications. For a given application, one or both of these values may be prescribed by process specifications or regulations. Knowledge of the dose distribution within irradiated material is essential to help meet these requirements. Dosimetry is essential to the radiation process since it i...
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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.
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 51649, 51818 and 51702 describe dosimetric procedures for electron beam and gamma facilities for radiation processing.  
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.  
1.4 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 Practice 52628, “Practice for Dosimetry in Radiation Processing”.  
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).  
1.6 Information about effective or regulatory dose limits and energy limits for X-ray applications is not within the scope of this practice.  
1.7 This ...

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ASTM ISO/ASTM51939-17(2022)(Practice)
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  
4.2 The assurance that blood and blood components have been properly irradiated is of crucial importance for patient health. This shall be demonstrated by means of accurate absorbed-dose measurements on the product, or in simulated product.  
4.3 Blood and blood components are usually irradiated using gamma radiation from 137Cs or 60Co sources, or X-radiation from X-ray units.  
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.  
4.6 Absorbed-dose measurements are performed within the blood or blood-equivalent volume for determining the absorbed-dose distribution. Such measurements are often performed using simulated product (for example, polystyrene is considered blood equivalent for 137Cs photon energies).  
4.7 Dosimetry is part of a measurement management system that is applied to ensure that the radiation process meets predetermined specifications (see ISO/ASTM Practice 52628).  
4.8 Blood and blood components are usually irradiated in chilled or frozen condition. Care should be taken, therefore, to ensure that the dosimeters and radiation-sensitive indicators can be used under such temperature conditions.  
4.9 Proper ...
SCOPE
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.  
1.2 This practice covers dosimetry for the irradiation of blood product for self-contained irradiators (free-standing irradiators) utilizing radionuclides such as 137Cs and  60Co, or X-radiation (bremsstrahlung). The absorbed dose range for blood irradiation is typically 15 Gy to 50 Gy.  
1.3 The photon energy range of X-radiation used for blood irradiation is typically from 40 keV to 300 keV.  
1.4 This practice also covers the use of radiation-sensitive indicators for the visual and qualitative indication that the product has been irradiated (see ISO/ASTM Guide 51539).  
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 Practice 52628 for dosimetry performed for blood irradiation. It is intended to be read in conjunction with ISO/ASTM Practice 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.  
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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...
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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.  
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ASTM E3270-21(Guide)
Standard Guide for Operational Qualification of Gamma Irradiators

SIGNIFICANCE AND USE
4.1 Operational qualification (OQ) will be used to demonstrate that the irradiator, as installed, is capable of operating and delivering dose to product being irradiated with defined acceptance criteria by determining dose distribution and magnitude through dose mapping exercises and relating these distributions to process parameters.  
4.2 The principle objectives of OQ are to:  
4.2.1 Establish the dose distribution and create a baseline PQ grid for mapping actual product,  
4.2.2 Establish the relationship for dose uniformity ratio (DUR) as a function of density,  
4.2.3 Establish the relationship for cycle time (CT) as a function of density and source activity, and  
4.2.4 Establish the relationship for minimum dose (kGy) as a function of density, cycle time and source activity.  
4.3 OQ exercises could augment or replace PQ exercises. It is the facility’s responsibility to document the rationale when using OQ data for PQ purposes.  
4.4 A design of experiments approach may help rationalize the types of OQ tests needed. For some irradiator changes, the minimum number of densities may be different depending on the degree of anticipated change in dose distribution. These decisions should be covered through a documented change control process. See ISO/ASTM 52701.  
4.5 This guide is not intended to address OQ requirements in research or experimental irradiators.  
4.6 An irradiation facility is able to process different process load configurations. For example, an irradiation container may be designed to accommodate boxes, sacks and drums. It is important to consider OQ studies that characterize the irradiator for different irradiation geometries.  
4.7 The bulk density, dimensions and atomic composition are important properties in dose mapping. See Appendix X2 for examples of materials for potential use in OQ studies.
SCOPE
1.1 This document provides guidance on operational qualification (OQ) tests to meet the OQ requirements defined in ISO 11137-1, ISO 14470, ISO/ASTM 51702, and ISO/ASTM 52303 for gamma irradiators.  
1.1.1 The types of OQ tests are discussed to help the user gain an increased understanding of operational aspects of their irradiator and determine which OQ tests are appropriate for the assessment of irradiator change.  
1.1.2 The facility should assess the rationale for the OQ tests chosen and for the ones that have been deemed to be unnecessary.  
1.2 Specific requirements for OQ are dependent on the application of the irradiation process and are not within the scope of this guide. For example, requirements for OQ when sterilizing healthcare products can be found in ISO 11137-1.  
1.3 A change to the irradiator is a component of the change control process. The OQ testing following the irradiator change is determined as part of the change control documentation and should include rationale to support decision(s) on which tests are required to be completed.  
1.4 For an OQ study following an irradiator change, the required OQ tests are defined procedurally with established acceptance criteria. (The OQ tests in the appendixes have examples of defined acceptance criteria with a rationale for the acceptance.) When multiple tests are used in the assessment of change, no individual OQ test should be solely relied upon; rather, the composite of OQ test results should be used to help provide a clear justification for the conclusion regarding irradiator change.  
1.5 Many calculations in this guide were completed using Microsoft Excel (for example, ANOVA, t-test, p-value), but numerous other software tools are commercially available.  
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...

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Standard Guide for Selection and Use of Mathematical Methods for Calculating Absorbed Dose in Radiation Processing Applications

SIGNIFICANCE AND USE
4.1 Use as an Analytical Tool—Mathematical methods provide an analytical tool to be employed for many applications related to absorbed dose determinations in radiation processing. Mathematical calculations may not be used as a substitute for routine dosimetry in some applications (for example, medical device sterilization, food irradiation).  
4.2 Dose Calculation—Absorbed-dose calculations may be performed for a variety of photon/electron environments and irradiator geometries.  
4.3 Evaluate Process Effectiveness—Mathematical models may be used to evaluate the impact of changes in product composition, loading configuration, and irradiator design on dose distribution.  
4.4 Complement or Supplement to Dosimetry—Dose calculations may be used to establish a detailed understanding of dose distribution, providing a spatial resolution not obtainable through measurement. Calculations may be used to reduce the number of dosimeters required to characterize a procedure or process (for example, dose mapping).  
4.5 Alternative to Dosimetry—Dose calculations may be used when dosimetry is impractical (for example, granular materials, materials with complex geometries, material contained in a package where dosimetry is not practical or possible).  
4.6 Facility Design—Dose calculations are often used in the design of a new irradiator and can be used to help optimize dose distribution in an existing facility or radiation process. The use of modeling in irradiator design can be found in Refs (2-7).  
4.7 Validation—The validation of the model should be done through comparison with reliable and traceable dosimetric measurements. The purpose of validation is to demonstrate that the mathematical method makes reliable predictions of dose and other transport quantities. Validation compares predictions or theory to the results of an appropriate experiment. The degree of validation is commensurate with the application. Guidance is given in the documents referenced in Annex A2.  
...
SCOPE
1.1 This guide describes different mathematical methods that may be used to calculate absorbed dose and criteria for their selection. Absorbed-dose calculations can determine the effectiveness of the radiation process, estimate the absorbed-dose distribution in product, or supplement or complement, or both, the measurement of absorbed dose.  
1.2 Radiation processing is an evolving field and annotated examples are provided in Annex A6 to illustrate the applications where mathematical methods have been successfully applied. While not limited by the applications cited in these examples, applications specific to neutron transport, radiation therapy and shielding design are not addressed in this document.  
1.3 This guide covers the calculation of radiation transport of electrons and photons with energies up to 25 MeV.  
1.4 The mathematical methods described include Monte Carlo, point kernel, discrete ordinate, semi-empirical and empirical methods.  
1.5 This guide is limited to the use of general purpose software packages for the calculation of the transport of charged or uncharged particles and photons, or both, from various types of sources of ionizing radiation. This standard is limited to the use of these software packages or other mathematical methods for the determination of spatial dose distributions for photons emitted following the decay of 137Cs or 60Co, for energetic electrons from particle accelerators, or for X-rays generated by electron accelerators.  
1.6 This guide assists the user in determining if mathematical methods are a useful tool. This guide may assist the user in selecting an appropriate method for calculating absorbed dose. The user must determine whether any of these mathematical methods are appropriate for the solution to their specific application and what, if any, software to apply.
Note 1: The user is urged to apply these predictive techniques while being aware of the need for experien...

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Standard Guide for Using Statistical Process Control Principles for Routine Dosimetry in Radiation Processing

SIGNIFICANCE AND USE
4.1 Control charts are the primary process monitoring tool in SPC for radiation processing. The general objectives of implementing a SPC program with control charts are to:  
4.1.1 Increase knowledge of the process,  
4.1.2 Control the process to provide a targeted or required process output,  
4.1.3 Reduce variation of the process output or in other ways improve the performance of a process, and  
4.1.4 Identify single process run results that are outside of established control limits but may be within the USL and LSL limits.  
4.2 These objectives when achieved:  
4.2.1 Reduce costs through reduction of losses due to scrap, rework, and investigation time,  
4.2.2 Improve consistency of the process output,  
4.2.3 Facilitate preventive process adjustments, and  
4.2.4 Provide evidence of accurate process targeting and process performance; state of statistical control.
SCOPE
1.1 This document provides guidance for the statistical analysis of the irradiation process from dosimetric data.  
1.2 This document is one of a set of guides and practices that provide recommendations for properly implementing dosimetry in radiation processing. It is intended to be read in conjunction with ISO/ASTM 52628 and ISO/ASTM 52303.  
1.3 This document employs a set of standard statistical methods and is intended to be read in conjunction with Practice E2586, Practice E2281, Practice E2587, and ASTM Manual MNL72.  
1.4 This guide is applicable to high-energy electron beam, X-ray and gamma-ray irradiation processes.  
1.5 This document assumes user knowledge of statistics, radiation processing, and radiation dosimetry. (See Annex A6)  
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 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/ASTM51310-22(Practice)
Standard Practice for Use of a Radiochromic Optical Waveguide Dosimetry System

SIGNIFICANCE AND USE
4.1 The radiochromic optical waveguide dosimetry system provides a means of measuring absorbed dose in materials. Under the influence of ionizing radiation such as photons, chemical reactions take place in the radiochromic optical waveguide creating and/or modifying optical absorbance bands in the visible region of the spectrum. Optical response is determined at selected wavelengths using the equations in 3.1.4. Examples of appropriate wavelengths for the analysis for specific dosimetry systems are provided by their manufacturers and in Refs (1-5).  
4.2 These dosimetry systems commonly are applied in the industrial radiation processing of a variety of products, for example, the sterilization of medical devices and radiation processing of foods (4-6).
Note 1: For additional information on dosimetry systems used in radiation processing, see ICRU Report 80.
SCOPE
1.1 This is a practice for using a radiochromic optical waveguide dosimetry system to measure absorbed dose in materials irradiated by photons and high energy electrons in terms of absorbed dose to water. The radiochromic optical waveguide dosimetry system is generally used as a routine dosimetry system.  
1.2 The optical waveguide dosimeter is classified as a Type II dosimeter on the basis of the complex effect of influence quantities (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 for an optical waveguide dosimetry system. It is intended to be read in conjunction with ISO/ASTM Practice 52628.  
1.4 This practice applies to radiochromic optical waveguide dosimeters that can be used within part or all of the specified ranges as follows:  
1.4.1 The absorbed dose range is from 1 Gy to 20 000 Gy.  
1.4.2 The absorbed dose rate is from 0.001 Gy/s to 1000 Gy/s.  
1.4.3 The radiation photon energy range is from 1 MeV to 10 MeV.  
1.4.4 The radiation electron energy range is from 3 MeV to 25 MeV.  
1.4.5 The irradiation temperature range is from –78 °C to +60 °C.  
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
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 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/ASTM51261-13(2020)(Practice)
Standard Practice for Calibration of Routine Dosimetry Systems for Radiation Processing

SIGNIFICANCE AND USE
4.1 Ionizing radiation is used to produce various desired effects in products. Examples of applications include the sterilization of medical products, microbial reduction, modification of polymers and electronic devices, and curing of inks, coatings, and adhesives (4).  
4.2 Absorbed-dose measurements, with statistical controls and documentation, are necessary to ensure that products receive the desired absorbed dose. These controls include a program that addresses requirements for calibration of routine dosimetry system.  
4.3 A routine dosimetry system calibration procedure as described in this document provides the user with a dosimetry system whose dose measurements are traceable to national or international standards for the conditions of use (see Annex A4). The dosimetry system calibration is part of the user’s measurement management system.
SCOPE
1.1 This practice specifies the requirements for calibrating routine dosimetry systems for use in radiation processing, including establishing measurement traceability and estimating uncertainty in the measured dose using the calibrated dosimetry system.
Note 1: Regulations or other directives exist in many countries that govern certain radiation processing applications such as sterilization of healthcare products and radiation processing of food requiring that absorbed-dose measurements be traceable to national or international standards (ISO 11137-1, Refs (1-3)2).  
1.2 The absorbed-dose range covered is up to 1 MGy.  
1.3 The radiation types covered are photons and electrons with energies from 80 keV to 25 MeV.  
1.4 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 ASTM E2628 “Practice for Dosimetry in Radiation Processing” for the calibration of routine dosimetry systems. It is intended to be read in conjunction with ASTM E2628 and the relevant ASTM or ISO/ASTM standard practice for the dosimetry system being calibrated referenced in Section 2.  
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/ASTM52701-13(2020)(Guide)
Standard Guide for Performance Characterization of Dosimeters and Dosimetry Systems for Use in Radiation Processing

SIGNIFICANCE AND USE
4.1 Ionizing radiation produces physical or chemical changes in many materials that can be measured and related to absorbed dose. Materials with radiation-induced changes that have been thoroughly studied can be used as dosimeters in radiation processing.  
Note 3: The scientific basis for commonly used dosimetry systems and detailed descriptions of the radiation-induced interactions are given in ICRU Report 80.  
4.2 Before a material can be considered for use as a dosimeter, certain characteristics related to manufacture and measurement of its response to ionizing radiation need to be considered, including:  
4.2.1 the ability to manufacture batches of the material with evidence demonstrating a reproducible radiation-induced change,  
4.2.2 the availability of instrumentation for measuring this change, and  
4.2.3 the ability to take into account effects of influence quantities on the dosimeter response and on the measured absorbed-dose values.  
4.3 Dosimeter/dosimetry system characterization is conducted to determine the performance characteristics for a dosimeter/dosimetry system related to its capability for measuring absorbed dose. The information obtained from dosimeter/dosimetry system characterization includes the reproducibility of the measured absorbed-dose value, the useful absorbed-dose range, effects of influence quantities, and the conditions under which the dosimeters can be calibrated and used effectively.
Note 4: When dosimetry systems are calibrated under the conditions of use, effects of influence quantities may be minimized or eliminated, because the effects can be accounted for or incorporated into the calibration method (see ISO/ASTM Practice 51261).  
4.4 The influence quantities of importance might differ for different radiation processing applications and facilities. For references to standards describing different applications and facilities, see ISO/ASTM Practice 52628.  
4.5 Classification of a dosimeter as a type I dosimeter ...
SCOPE
1.1 This guide provides guidance on determining the performance characteristics of dosimeters and dosimetry systems used in radiation processing.  
1.2 This guide describes the influence quantities that might affect the performance of dosimeters and dosimetry systems and that should be considered during dosimeter/dosimetry system characterization.  
1.3 Users of this guide are directed to existing standards and literature for procedures to determine the effects from individual influence quantities and from combinations of more than one influence quantity.  
1.4 Guidance is provided regarding the roles of the manufacturers, suppliers, and users in the characterization of dosimeters and dosimetry systems.  
1.5 This guide does not address how the dosimeter/dosimetry system characterization information is to be used in radiation processing applications or in the calibration of dosimetry systems.
Note 1: For guidance on the use of dosimeter/dosimetry system characterization information for the selection and use of a dosimetry system, the user is directed to ISO/ASTM Practice 52628.
Note 2: For guidance on the use of dosimeter/dosimetry system characterization information for dosimetry system calibration, the user is directed to ISO/ASTM Practice 51261.  
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 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/ASTM52116-13(2020)(Practice)
Standard Practice for Dosimetry for a Self-Contained Dry-Storage Gamma Irradiator

SIGNIFICANCE AND USE
4.1 The design and operation of a self-contained irradiator should ensure that reproducible absorbed doses are obtained when the same irradiation parameters are used. Dosimetry is performed to determine the relationship between the irradiation parameters and the absorbed dose.  
4.1.1 For most applications, the absorbed dose is expressed as absorbed dose to water (see ISO/ASTM Practice 51261). For conversion of absorbed dose to water to that to other materials, for example, silicon, see Annex A1 of ISO/ASTM Practice 51261.  
4.2 Self-contained dry-storage gamma irradiators contain properly shielded radioactive sources, namely  137Cs or  60Co, that emit ionizing electromagnetic radiation (gamma radiation). These irradiators have an enclosed, accessible irradiator sample chamber connected with a sample positioning system, for example, irradiator drawer, rotor, or irradiator turntable, as part of the irradiation device.  
4.3 Self-contained dry-storage gamma irradiators can be used for many radiation processing applications, including the calibration irradiation of dosimeters; studies of dosimeter influence quantities; radiation effects studies, and irradiation of materials or biological samples for process compatibility studies; batch irradiations of microbiological, botanical, or in-vitro samples; irradiation of small animals; radiation “hardness” testing of electronics components and other materials; and batch radiation processing of containers of samples.
Note 1: Self-contained dry-storage gamma irradiators contain a sealed radiation source, or an array of sealed radiation sources securely held in a dry container constructed of solid materials. The sealed radiation sources are shielded at all times, and human access to the chamber undergoing irradiation is not physically possible due to the irradiator’s design configuration (see ANSI/HPS N43.7).
Note 2: For reference–standard dosimetry, the absorbed dose and absorbed-dose rate can be expressed in water or o...
SCOPE
1.1 This practice outlines dosimetric procedures to be followed with self-contained dry-storage gamma irradiators. For irradiators used for routine processing, procedures are given to ensure that product processed will receive absorbed doses within prescribed limits.  
1.2 This practice covers dosimetry in the use of dry-storage gamma irradiators, namely self-contained dry-storage 137Cs or  60Co irradiators (shielded freestanding irradiators). It does not cover underwater pool sources, panoramic gamma sources, nor does it cover self-contained bremsstrahlung X-ray units.  
1.3 The absorbed-dose range for the use of the dry-storage self-contained gamma irradiators covered by this practice is typically 1 to 105 Gy, depending on the application. The absorbed-dose rate range typically is from 10–2 to 103 Gy/min.  
1.4 For irradiators supplied for specific applications, specific ISO/ASTM or ASTM practices and guides provide dosimetric procedures for the application. For procedures specific to dosimetry in blood irradiation, see ISO/ASTM Practice 51939. For procedures specific to dosimetry in radiation research on food and agricultural products, see ISO/ASTM Practice 51900 . For procedures specific to radiation hardness testing, see ASTM Practice E1249. For procedures specific to the dosimetry in the irradiation of insects for sterile release programs, see ISO/ASTM Guide 51940. In those cases covered by ISO/ASTM 51939, 51900 , 51940, or ASTM E1249, those standards take precedence.  
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 ASTM E2628, “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 ...

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