E61.03 - Dosimetry Application

SIGNIFICANCE AND USE
4.1 This guide is one of a set of guides and practices that provide recommendations for properly implementing dosimetry in radiation processing. In order to understand and effectively use this and other dosimetry standards, consider first “Practice for Dosimetry in Radiation Processing,” ASTM/ISO 52628, which describes the basic requirements that apply when making absorbed dose measurements in accordance with the ASTM E61 series of dosimetry standards. In addition, ASTM/ISO 52628 provides guidance on the selection of dosimetry systems and directs the user to other standards that provide information on individual dosimetry systems, calibration methods, uncertainty estimation and radiation processing applications.  
4.2 Radiation processing is carried out under fixed path conditions where (a) a process load is automatically moved through the radiation field by mechanical means or (b) a process load is irradiated statically by manually placing product at predetermined positions before the process is started. In both cases the process is controlled in such a manner that the process load position(s) and orientation(s) are reproducible within specified limits.
Note 2: Static irradiation encompasses irradiation of the process load using either manual rotation, no rotation or automated rotation.  
4.3 Some radiation processing facilities that utilize a fixed conveyor path for routine processing may also characterize a region within the radiation field for static radiation processing, sometimes referred to as “Off Carrier” processing.  
4.4 Many radiation processing applications require a minimum absorbed dose (to achieve a desired effect or to fulfill a legal requirement), and a maximum absorbed dose (to ensure that the product, material or substance still meets functional specifications or to fulfill a legal requirement).  
4.5 Information from the dose mapping is used to:  
4.5.1 Characterize the radiation process and assess the reproducibility of absorbed-dose va...
SCOPE
1.1 This document provides guidance in determining absorbed-dose distributions (mapping) in products, materials or substances irradiated in gamma, X-ray (bremsstrahlung) and electron beam facilities.
Note 1: For irradiation of food and the radiation sterilization of health care products, specific ISO and ISO/ASTM standards containing dose mapping requirements exist. See ISO/ASTM Practices 51608, 51649, 51702 and 51818 and ISO 11137-1. Regarding the radiation sterilization of health care products, in those areas covered by ISO 11137-1, that standard takes precedence.  
1.2 This guide is one of a set of standards that provides recommendations for properly implementing dosimetry in radiation processing. It is intended to be read in conjunction with ISO/ASTM 52628.  
1.3 Methods of analyzing the dose map data are described. Examples are provided of statistical methods that may be used to analyze dose map data.  
1.4 Dose mapping for bulk flow processing and fluid streams is not discussed.  
1.5 Dosimetry is an element of a total quality management system for an irradiation facility. Other controls besides dosimetry may be required for specific applications such as medical device sterilization and food preservation.  
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.

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...

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 ...

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.  
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...

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...

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.

SIGNIFICANCE AND USE
4.1 A variety of irradiation processes use low energy electron beam facilities to modify product characteristics. Dosimetry requirements, the number and frequency of measurements, and record keeping requirements will vary depending on the type and end use of the products being processed. Dosimetry is often used in conjunction with physical, chemical, or biological testing of the product, to help verify specific treatment parameters.
Note 2: In many cases dosimetry results can be related to other quantitative product properties; for example, gel fraction, melt flow, elastic modulus, molecular weight distribution, or degree of cure.  
4.2 Radiation processing specifications usually include a minimum or maximum absorbed dose limit, or both. For a given application these limits may be set by government regulation or by limits inherent to the product itself.  
4.3 Critical operating parameters must be controlled to obtain reproducible dose distribution in processed materials. The electron beam energy, beam current, beam width and process line speed (conveying speed) affect absorbed dose.  
4.4 Before any electron beam facility can be routinely utilized, it must be characterized to determine the relationship between dose to product and the main operating parameters. This involves testing of the process equipment, calibrating the measuring instruments and the dosimetry system, and demonstrating the ability to consistently deliver the required dose within predetermined specifications.  
4.5 In order to establish metrological traceability for a dosimetry system and to measure doses with a known level of uncertainty, it is necessary to calibrate the dosimetry system under irradiation conditions that are consistent with those encountered in routine use. For example, a dosimetry system calibration conducted using penetrating gamma radiation or high energy electrons may result in significant dose measurement errors when the dosimetry system is used at low energy electron b...
SCOPE
1.1 This practice covers dosimetric procedures to be followed in installation qualification, operational qualification and performance qualification (IQ, OQ, PQ), and routine processing at electron beam facilities to ensure that the product has been treated with an acceptable range of absorbed doses. Other procedures related to IQ, OQ, PQ, and routine product processing that may influence absorbed dose in the product are also discussed.  
1.2 The electron beam energy range covered in this practice is between 80 and 300 keV, generally referred to as low energy.  
1.3 Dosimetry is only one component of a total quality assurance program for an irradiation facility. Other measures may be required for specific applications such as medical device sterilization and food preservation.  
1.4 Other specific ISO and ASTM standards exist for the irradiation of food and the radiation sterilization of health care products. For the radiation sterilization of health care products, see ISO 11137-1. In those areas covered by ISO 11137-1, that standard takes precedence. For food irradiation, see ISO 14470. Information about effective or regulatory dose limits for food products is not within the scope of this practice (see ASTM F1355 and F1356).  
1.5 This document is one of a set of standards that provides recommendations for properly implementing dosimetry in radiation processing, and describes a means of achieving compliance with the requirements of ISO/ASTM 52628. It is intended to be read in conjunction with ISO/ASTM 52628.  
1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.7 This international standard was developed in accordance with internationally recognized principles on s...

SIGNIFICANCE AND USE
4.1 This guide is one of a set of guides and practices that provide recommendations for properly implementing dosimetry in radiation processing. In order to understand and effectively use this and other dosimetry standards, consider first “Practice for Dosimetry in Radiation Processing,” ASTM/ISO 52628, which describes the basic requirements that apply when making absorbed dose measurements in accordance with the ASTM E10.01 series of dosimetry standards. In addition, ASTM/ISO 52628 provides guidance on the selection of dosimetry systems and directs the user to other standards that provide information on individual dosimetry systems, calibration methods, uncertainty estimation and radiation processing applications.  
4.2 Radiation processing is carried out under fixed path conditions where (a) a process load is automatically moved through the radiation field by mechanical means or (b) a process load is irradiated statically by manually placing product at predetermined positions before the process is started. In both cases the process is controlled in such a manner that the process load position(s) and orientation(s) are reproducible within specified limits.
Note 2: Static irradiation encompasses irradiation of the process load using either manual rotation, no rotation or automated rotation.  
4.3 Some radiation processing facilities that utilize a fixed conveyor path for routine processing may also characterize a region within the radiation field for static radiation processing, sometimes referred to as “Off Carrier” processing.  
4.4 Many radiation processing applications require a minimum absorbed dose (to achieve a desired effect or to fulfill a legal requirement), and a maximum absorbed dose (to ensure that the product, material or substance still meets functional specifications or to fulfill a legal requirement).  
4.5 Information from the dose mapping is used to:  
4.5.1 Characterize the radiation process and assess the reproducibility of absorbed-dose...
SCOPE
1.1 This document provides guidance in determining absorbed-dose distributions (mapping) in products, materials or substances irradiated in gamma, X-ray (bremsstrahlung) and electron beam facilities.
Note 1: For irradiation of food and the radiation sterilization of health care products, specific ISO and ISO/ASTM standards containing dose mapping requirements exist. See ISO/ASTM Practices 51431, 51608, 51649, 51702 and 51818 and ISO 11137-1. Regarding the radiation sterilization of health care products, in those areas covered by ISO 11137-1, that standard takes precedence.  
1.2 This guide is one of a set of standards that provides recommendations for properly implementing dosimetry in radiation processing. it is intended to be read in conjunction with ISO/ASTM 52628.  
1.3 Methods of analyzing the dose map data are described. Examples are provided of statistical methods that may be used to analyze dose map data.  
1.4 Dose mapping for bulk flow processing and fluid streams is not discussed.  
1.5 Dosimetry is an element of a total quality management system for an irradiation facility. Other controls besides dosimetry may be required for specific applications such as medical device sterilization and food preservation.  
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 requirements prior to use.

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 and health pract...

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 ...

SIGNIFICANCE AND USE
A variety of irradiation processes uses low energy electron beam facilities to modify product characteristics. Dosimetry requirements, the number and frequency of measurements, and record keeping requirements will vary depending on the type and end use of the products being processed. Dosimetry is often used in conjunction with physical, chemical, or biological testing of the product, to help verify specific treatment parameters.
Note 1—In many cases dosimetry results can be related to other quantitative product properties; for example, gel fraction, melt flow, modulus, molecular weight distribution, or cure analysis tests.
Radiation processing specifications usually include a minimum or maximum absorbed dose limit, or both. For a given application these limits may be set by government regulation or by limits inherent to the product itself.
Critical process parameters must be controlled to obtain reproducible dose distribution in processed materials. The electron beam energy, beam current, beam width and process line speed (conveying speed) affect absorbed dose.
Before any electron beam facility can be routinely utilized, it must be validated to determine its effectiveness. This involves testing of the process equipment, calibrating the measuring instruments and the dosimetry system, and demonstrating the ability to consistently deliver the required dose within predetermined specifications.  
In order for a dosimetry system to be effective in low-energy electron irradiation applications and to measure doses with an acceptable level of uncertainty, it is necessary to calibrate the dosimetry system under irradiation conditions that are consistent with those encountered in routine use. For example, a dosimetry system calibration conducted using penetrating gamma radiation or high energy electrons may result in significantly inaccurate dose measurement when the dosimetry system is used at low energy electron beam facilities. Details of calibration are discusse...
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1.1 This practice covers dosimetric procedures to be followed in installation qualification, operational qualification and performance qualification (IQ, OQ, PQ), and routine processing at electron beam facilities to ensure that the product has been treated with an acceptable range of absorbed doses. Other procedures related to IQ, OQ, PQ, and routine product processing that may influence absorbed dose in the product are also discussed.
1.2 The electron beam energy range covered in this practice is between 80 and 300 keV, generally referred to as low energy.
1.3 Dosimetry is only one component of a total quality assurance program for an irradiation facility. Other measures may be required for specific applications such as medical device sterilization and food preservation.
1.4 Other specific ISO and ASTM standards exist for the irradiation of food and the radiation sterilization of health care products. For the radiation sterilization of health care products, see ISO 11137. In those areas covered by ISO 11137, that standard takes precedence. For food irradiation, see ISO 14470:2011. Information about effective or regulatory dose limits for food products is not within the scope of this practice (see ASTM F1355 and F1356).
1.5 This document is one of a set of standards that provides recommendations for properly implementing and utilizing dosimetry in radiation processing. It is intended to be read in conjunction with ASTM E2232, “Practice for Dosimetry in Radiation Processing”.
1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

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 process equipment, calibrat...
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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 and health practices and determine the applicability of regulatory limitations prior to use.

SIGNIFICANCE AND USE
This guide is one of a set of guides and practices that provide recommendations for properly implementing dosimetry in radiation processing. In order to understand and effectively use this and other dosimetry standards, consider first “Practice for Dosimetry in Radiation Processing,” ASTM Practice E2628, which describes the basic requirements that apply when making absorbed dose measurements in accordance with the ASTM E10.01 series of dosimetry standards. In addition, ASTM Practice E2628 provides guidance on the selection of dosimetry systems and directs the user to other standards that provide information on individual dosimetry systems, calibration methods, uncertainty estimation and radiation processing applications.
Radiation processing is carried out under fixed path conditions where (a) a process load is automatically moved through the radiation field by mechanical means or (b) a process load is irradiated statically by manually placing product at predetermined positions before the process is started. In both cases the process is controlled in such a manner that the process load position(s) and orientation(s) are reproducible within specified limits.
Note 2—Static irradiation encompasses irradiation of the process load using either manual rotation, no rotation or automated rotation.
Some radiation processing facilities that utilize a fixed conveyor path for routine processing may also characterize a region within the radiation field for static radiation processing, sometimes referred to as “Off Carrier” processing.
Many radiation processing applications require a minimum absorbed dose (to achieve a desired effect or to fulfill a legal requirement), and a maximum dose that can be tolerated (while the product, material or substance still meets functional specifications or to fulfill a legal requirement).
Dose mapping is used to:  
Characterize the radiation process and assess the reproducibility of absorbed-dose values, which may be used as part of ...
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1.1 This document provides guidance in determining absorbed-dose distributions (mapping) in products, materials or substances irradiated in gamma, X-ray (bremsstrahlung) and electron beam facilities.
Note 1—For irradiation of food and the radiation sterilization of health care products, other specific ISO and ISO/ASTM standards containing dose mapping requirements exist. For food irradiation, see ISO/ASTM 51204, Practice for Dosimetry in Gamma Irradiation Facilities for Food Processing and ISO/ASTM 51431, Practice for Dosimetry in Electron Beam and X-Ray (Bremsstrahlung) Irradiation Facilities for Food Processing. For the 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. ISO/ASTM 51608, Practice for Dosimetry in an X-ray (Bremsstrahlung) Facility for Radiation Processing, ISO/ASTM 51649, Practice for Dosimetry in an Electron Beam Facility for Radiation Processing at Energies between 300 keV and 25 Mev, ISO/ASTM 51702, Practice for Dosimetry in a Gamma Irradiation Facility for Radiation Processing, and ISO/ASTM 51818, Practice for Dosimetry in an Electron Beam Facility for Radiation Processing at Energies Between 80 and 300 KeV also contain dose mapping requirements.
1.2 This guide is one of a set of standards that provides recommendations for properly implementing dosimetry in radiation processing. it is intended to be read in conjunction with ASTM Practice E2628.
1.3 Methods of analyzing the dose map data are described. Examples are provided of statistical methods that may be used to analyze dose map data.
1.4 Dose mapping for bulk flow processing and fluid streams is not discussed.
1.5 Dosimetry is only one component of a total quality program for an irradiat...

SIGNIFICANCE AND USE
4.1 This guide is one of a set of guides and practices that provide recommendations for properly implementing dosimetry in radiation processing. In order to understand and effectively use this and other dosimetry standards, consider first “Practice for Dosimetry in Radiation Processing,” ASTM Practice E2628, which describes the basic requirements that apply when making absorbed dose measurements in accordance with the ASTM E10.01 series of dosimetry standards. In addition, ASTM Practice E2628 provides guidance on the selection of dosimetry systems and directs the user to other standards that provide information on individual dosimetry systems, calibration methods, uncertainty estimation and radiation processing applications.  
4.2 Radiation processing is carried out under fixed path conditions where (a) a process load is automatically moved through the radiation field by mechanical means or (b) a process load is irradiated statically by manually placing product at predetermined positions before the process is started. In both cases the process is controlled in such a manner that the process load position(s) and orientation(s) are reproducible within specified limits.Note 2—Static irradiation encompasses irradiation of the process load using either manual rotation, no rotation or automated rotation.  
4.3 Some radiation processing facilities that utilize a fixed conveyor path for routine processing may also characterize a region within the radiation field for static radiation processing, sometimes referred to as “Off Carrier” processing.  
4.4 Many radiation processing applications require a minimum absorbed dose (to achieve a desired effect or to fulfill a legal requirement), and a maximum absorbed dose (to ensure that the product, material or substance still meets functional specifications or to fulfill a legal requirement).  
4.5 Information from the dose mapping is used to:  
4.5.1 Characterize the radiation process and assess the reproducibility of absorbe...
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1.1 This document provides guidance in determining absorbed-dose distributions (mapping) in products, materials or substances irradiated in gamma, X-ray (bremsstrahlung) and electron beam facilities. Note 1—For irradiation of food and the radiation sterilization of health care products, specific ISO and ISO/ASTM standards containing dose mapping requirements exist. See ISO/ASTM Practices 51431, 51608, 51649, 51702 and 51818 and ISO 11137-1. Regarding the radiation sterilization of health care products, in those areas covered by ISO 11137-1, that standard takes precedence.  
1.2 This guide is one of a set of standards that provides recommendations for properly implementing dosimetry in radiation processing. it is intended to be read in conjunction with ASTM Practice E2628.  
1.3 Methods of analyzing the dose map data are described. Examples are provided of statistical methods that may be used to analyze dose map data.  
1.4 Dose mapping for bulk flow processing and fluid streams is not discussed.  
1.5 Dosimetry is an element of a total quality management system for an irradiation facility. Other controls besides dosimetry may be required for specific applications such as medical device sterilization and food preservation.  
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 requirements prior to use.

SIGNIFICANCE AND USE
4.1 A variety of products and materials may be irradiated with X-radiation to modify their characteristics and improve the economic value or for health-related purposes. Examples are single-use medical devices (sterilization), agricultural commodities (preservation), and various polymeric products (material modification). Dosimetry requirements for X-ray processing may vary depending on the type and end use of the product.
4.2 Dosimeters are used as means of monitoring the radiation process.
NOTE 3 - Dosimetry is required for regulated irradiation processes, such as the sterilization of medical devices and the preservation of food, because the results may affect the health of the consumer. It is 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 treatment process.
NOTE 4 - It is necessary to specify the material in which radiation is absorbed. Frequently, water is selected as the reference material for this purpose. Water is a convenient medium to use because its radiation absorption and scattering properties are close to those of tissue and it is universally available and understood. The requirement of tissueequivalency historically originated from radiation therapy applications. Absorbed dose in materials other than water may be determined by applying conversion factors in accordance with ISO/ASTM Guide 51261.
4.3 Radiation processing specifications usually include a pair of absorbed-dose limits: a minimum value to ensure the intended beneficial effect and a maximum value to avoid product degradation. 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 meet these requirements.
4.4 Several critical parameters must be controll...
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1.1 This practice outlines the installation qualification program for an X-ray (bremsstrahlung) irradiator and the dosimetric procedures to be followed during operational qualification, performance qualification and routine processing to ensure that the entire 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. Information about effective or regulatory dose limits and energy limits for X-radiation is not within the scope of this practice.
1.2 In contrast to monoenergetic gamma radiation, the bremsstrahlung 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 and ).
1.3 Dosimetry is only one component of a total quality assurance program for an irradiation facility. Other controls besides dosimetry may be required for specific applications, such as medical device sterilization and food preservation.
1.4 For the irradiation of food and the radiation sterilization of health care products, other specific ISO standards exist. For food irradiation, see ISO/ASTM Practice 51431. For the radiation sterilization of health care products, see ISO 11137. In those areas covered by ISO/ASTM Practice 51431 or ISO 11137, those standards take precedence.Note 1
For guidance in the selection, calibration, and use of specific dosimeters and interpretation of absorbed dose in the product from dose measurements, see the documents listed in Section.Note 2
Bremsstrahlung characteristics are similar to those of gamma radiation from radioactive nuclides. See ISO/ASTM Practices 51204 and 51702 for the applications of dosimetry in the characterization and operation of gamma irradiation facilities. For information concerning electron beam irradiation technology and dosimet...

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. For example, 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 medical devices,
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,
4.1.11 Research on radiation effects on materials.
NOTE 2 - Dosimetry is required for regulated radiation processes such as sterilization of medical devices (see ISO 11137 and Refs (1-4)5 and preservation of food (see ISO/ASTM 51431 and Ref (5). 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.
4.2 Dosimeters are used as a means of monitoring the radiation process.
NOTE 3 - Measured dose is often characterized as absorbed dose in water to have a traceable standard reference. Moreover, materials commonly found in 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 in accordance with ISO/ASTM Guide 51261.
4.3 A beneficial irradiation process is usually s...
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1.1 This practice covers dosimetric procedures to be followed in Installation Qualification, Operational Qualification and Performance Qualifications (IQ, OQ, PQ), and routine processing at electron beam facilities to ensure that the product has been treated with an acceptable range of absorbed doses. Other procedures related to IQ, OQ, PQ, and routine product processing that may influence absorbed dose in the product are also discussed.Note 1
For guidance in the selection and calibration of dosimeters, see ISO/ASTM Guide 51261. For further guidance in the use of specific dosimetry systems, and interpretation of the measured absorbed dose in the product, also see ISO/ASTM Practices 51275, 51276, 51431, 51607, 51631, 51650, and 51956. For use with electron energies above 5 MeV, see Practice E 1026, and ISO/ASTM Practices 51205, 51401, 51538, and 51540 for discussions of specific large volume dosimeters. For discussion of radiation dosimetry for pulsed radiation, see ICRU Report 34.
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 an irradiation facility. Other measures besides dosimetry may be required for specific applications such as medical device sterilization and food preservation.
1.4 Other specific ISO and ASTM standards exist for the irradiation of food and the radiation sterilization of health care products. For food irradiation, see ISO/ASTM Practice 51431. For the radiation sterilization of health care products, see ISO 11137. In those areas covered by ISO 11137, that standard takes precedence.
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 and health practices and determine the applicabili...

SIGNIFICANCE AND USE
Radiation processing is carried out under fixed path conditions where (a) a process load is automatically moved through the radiation field by mechanical means or (b) a process load is irradiated statically by manually placing product at predetermined positions before the process is started. In both cases the process is controlled in such a manner that the process load position(s) and orientation(s) are reproducible within specified limits.
Some radiation processing facilities that utilize a fixed conveyor path for routine processing may also characterize a region within the radiation field for static radiation processing, sometimes referred to as “Off Carrier” processing.
Radiation processing may require a minimum absorbed dose (to achieve a desired effect or to fulfill a legal requirement), and a maximum dose that can be tolerated (while the product, material or substance still meets functional specifications or to fulfill a legal requirement).
Dose mapping is used to characterize the radiation process and assess the reproducibility of absorbed-dose results, which may be used as part of operational qualification and performance qualification.
Dose mapping is used to determine the spatial distribution of absorbed doses and the zone(s) of maximum and minimum absorbed doses throughout a process load, which may consist of an actual or simulated product.
Dose mapping is used to establish the relationship between the dose at a reference position and the dose within the minimum and maximum dose zones established for a process load.
Dose mapping is used to verify mathematical dose calculation methods. See Guide E 2232.
Dose mapping is used to determine the process shutdown and startup transit dose effect on the distribution of absorbed dose and the magnitude of the minimum and maximum doses.
Dose mapping is used to assess the impact on the distribution of absorbed dose and the magnitude of the minimum and maximum doses resulting from the transition from on...
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1.1 This document provides guidance in determining absorbed-dose distributions in products, materials or substances irradiated in gamma, X-ray (bremsstrahlung) and electron beam facilities.
Note 1—For irradiation of food and the radiation sterilization of health care products, other specific ISO and ISO/ASTM standards containing dose mapping requirements exist. For food irradiation, see ISO/ASTM 51204, Practice for Dosimetry in Gamma Irradiation Facilities for Food Processing and ISO/ASTM 51431, Practice for Dosimetry in Electron and Bremsstrahlung Irradiation Facilities for Food Processing. For the radiation sterilization of health care products, see ISO 11137: 1995, Sterilization of Health Care Products Requirements for Validation and Routine Control Radiation Sterilization. In those areas covered by ISO 11137, that standard takes precedence. ISO/ASTM Practice 51608, ISO/ASTM Practice 51649, and ISO/ASTM Practice 51702 also contain dose mapping requirements.
1.2 Methods of analyzing the dose map data are described. Examples are provided of statistical methods that may be used to analyze dose map data.
1.3 Dose mapping for bulk flow processing and fluid streams is not discussed.
1.4 Dosimetry is only one component of a total quality program for an irradiation facility. Other controls besides dosimetry may be required for specific applications such as medical device sterilization and food preservation.
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 and health practices and determine the applicability of regulatory requirements prior to use.