E61.04 - Specialty Application

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.  
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 ...

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...

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 ...

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.  
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 ...

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...

SIGNIFICANCE AND USE
4.1 This guide is intended to provide direction on dosimetry for experiments in food and agricultural research, and on the reporting of dosimetry results. Research concerning the effectiveness of irradiation of food and agricultural products to achieve a defined benefit involves very different absorbed-dose specifications from one study and one product to another. For example, the absorbed dose required to sterilize fruit flies is much lower than the doses required to inactivate some bacterial pathogens in meat, or to decontaminate spices.
Note 4: Examples of the relevant effects of irradiation include reduction of viable food-borne bacteria, viruses and parasites and phytosanitary treatment (such as disinfestation of fruits and vegetables), prevention of sprouting, delay of ripening, and changes in product chemistry and quality. Further discussion of these effects is outside the scope of this guide. Refer to ASTM Guides F1355, F1356, F1736 and F1885.  
4.2 Proper reporting of the irradiation aspect is important since the degree of biological effect may be a function of various factors such as the radiation source, the absorbed-dose rate, energy of the incident radiation, environmental effects during irradiation, and the type of incident radiation. This guide attempts to highlight the information, including the methodology and results of the absorbed-dose measurements, necessary for an experiment to be repeatable by other researchers.
Note 5: Factors that may influence the response of agricultural products to ionizing radiation include genus, species, variety, vigor, life stage, initial quality, state of ripeness, temperature, moisture content, pH, packaging, shipping, and storage conditions. Although these factors are not discussed in this guide, they should be considered when planning experiments (see ASTM Guides F1355, F1356, F1640, F1736 and F1885.  
4.3 Ideally, an experiment should be designed to irradiate the sample as uniformly as possible. In practice...
SCOPE
1.1 This guide covers the minimum requirements for dosimetry needed to conduct research on the effect of radiation on food and agricultural products. Such research includes establishment of the quantitative relationship between absorbed dose and the relevant effects in these products. This guide also describes the overall need for dosimetry in such research, and in reporting of the results. Dosimetry must be considered as an integral part of the experiment.
Note 1: The Codex Alimentarius Commission has developed an international General Standard and a Code of Practice that address the application of ionizing radiation to the treatment of foods and that strongly emphasize the role of dosimetry for ensuring that irradiation will be properly performed  (1).2
Note 2: This guide includes tutorial information in the form of Notes. Researchers should also refer to the references provided at the end of the standard, and other applicable scientific literature, to assist in the experimental methodology as applied to dosimetry (2-10).  
1.2 This guide covers research conducted using the following types of ionizing radiation: gamma radiation, X-ray (bremsstrahlung), and electron beams.  
1.3 This guide describes dosimetry requirements for establishing the experimental method and for routine experiments. It does not include dosimetry requirements for installation qualification or operational qualification of the irradiation facility. These subjects are treated in ISO/ASTM Practices 51204, 51431, 51608, 51649, and 51702.  
1.4 This guide is not intended to limit the flexibility of the experimenter in the determination of the experimental methodology. The purpose of the guide is to ensure that the radiation source and experimental methodology are chosen such that the results of the experiment will be useful and understandable to other scientists and regulatory agencies.  
1.5 The overall uncertainty in the absorbed-dose measure...

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...

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 and health practices and to determine the applicability or regulatory limitations prior to use.

SIGNIFICANCE AND USE
4.1 The assurance that blood and blood components have been properly irradiated is of crucial importance for patient health. The irradiator operator must demonstrate by means of accurate absorbed-dose measurements on the product, or in simulated product, that the specified absorbed dose has been achieved throughout the product.
4.2 Blood and blood components are irradiated at predetermined 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).6
4.3 Blood and blood components may be treated with ionizing radiation, such as gamma radiation from 137Cs or 60Co sources, and from self-contained X-ray (bremsstrahlung) units and medical linear X-ray (bremsstrahlung) and electron accelerators used primarily for radiotherapy.
4.3.1 The terms “gamma rays” and “gamma radiation” are used interchangeably, as are the terms “X-ray” and “Xradiation.”
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 2.4.
4.5 For each blood irradiator, an absorbed-dose rate at a reference position within the canister is measured by the manufacturer as part of acceptance testing using a reference-standard dosimetry system. That reference-standard measurement is used to calculate the timer setting required to deliver the specified absorbed dose to the center of the canister with blood and blood components, or other reference position. Either relative or absolute absorbed-dose measurements are performed within the blood- or blood-equivalent volume for determining the absorbed-dose distribution. Accurate radiation dosimetry at a reference position which could be the position of the maximum absorbed dose (Dmax) or minimum absorbed ...
SCOPE
1.1 This practice outlines irradiator installation qualification, operational qualification, performance qualification, and routine product processing dosimetric procedures to be followed in the irradiation of blood and blood components by the blood-banking community. If followed, these procedures will help to ensure that the products processed with ionizing radiation from gamma, X-radiation (bremsstrahlung), or electron sources receive absorbed doses within a predetermined range.
1.2 This practice covers dosimetry for the irradiation of blood for these types of irradiators: self-contained irradiators (free-standing irradiators) utilizing 137Cs, 60Co or X-radiation (bremsstrahlung), teletherapy units, and electron accelerators. The absorbed dose range for blood irradiation is typically 15 Gy to 50 Gy. In some jurisdictions, the absorbed dose range for blood irradiation is 25 Gy to 50 Gy.
1.3 The energy range is typically from approximately 40 keV to 5 MeV for photons, and up to 10 MeV for electrons.
1.4 This practice also covers the use of radiation-sensitive indicators for the visual and qualitative indication that the product has been irradiated.
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 to determine the applicability or regulatory limitations prior to use.

SIGNIFICANCE AND USE
4.1 Indicators may be used to show that products have been exposed to a radiation source. They should be used only to provide a qualitative indication of radiation exposure and may be used to distinguish processed loads that have been irradiated from unirradiated process loads.
NOTE 1—The use of indicators does not eliminate the need for other process-control procedures, such as quantitative dosimetry or the controlled segregation of irradiated from nonirradiated products.
NOTE 2—See ISO/ASTM Standards 51204, 51431, 51608, 51649, 51702, 51939, and 51940 for information on the use of indicators in the various types of processing facilities and for unique product applications.
4.2 The indicator manufacturer is obliged to supply a statement regarding the approximate dose level at which the examiner (20/20 vision), at standard illumination (unfiltered daylight, or artificial light of the spectrum and intensity defined by the proper ASTM standard), is able to determine the visual change in the indicator.
SCOPE
1.1 This guide covers procedures for using radiationsensitive indicators (referred to hereafter as indicators) in radiation processing. These indicators may be labels, papers, inks or packaging materials which undergo a visual change when exposed to ionizing radiation (1-5).2
1.2 The purpose for using indicators is to determine visually whether or not a product has been irradiated, rather than to measure different dose levels.
1.3 Indicators are not dosimeters and shall not be used as a substitute for proper dosimetry. Information about dosimetry systems for radiation processing is provided in other ASTM and ISO/ASTM documents (see ISO/ASTM Guide 51261).
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
4.1 The major use of factory-reared insects is in sterile insect release programs (for example, Sterile Insect Technique, or SIT) for suppressing or eradicating pest populations (2,3). Large numbers of reproductively sterile (irradiated) insects are released into an area where a wild “target population” of the same species exists. The wild population is reduced to the extent that the sterile males are successful in mating with wild females. The radiation dose absorbed by the factory-reared insects should be within a range that induces the desired level of sterility without substantially reducing the ability of factoryreared males to compete with wild males for mates. Species targeted by SIT programs are typically major pests affecting agriculture or human health, so the assurance by standardized dosimetry that insects have been properly irradiated is of crucial importance to agriculture growers, agricultural regulators, public health officials, and the public (3). The irradiator operator must demonstrate by means of accurate absorbed-dose measurements that all insects have received absorbed dose within the specified range.
4.2 Another use of factory-reared insects is in the production of parasitoids for release against populations of insect pests (4). Parasitoids are insects that spend the larval stage feeding within or on the body of a “host” species, typically killing the host. In some parasitoid programs, factory-reared host insects are irradiated before being offered to parasitoids. This eliminates the need to separate unparasitized hosts from parasitoids so that fertile, unparasitized host insects are not inadvertently released into the field.
4.3 Factory-reared insects may be treated with ionizing radiation, such as gamma radiation from 137Cs or 60Co sources, or X-radiation or electrons from accelerators. Gamma irradiation of insects is often carried out in small, fixed-geometry, dry-storage irradiators (5). Dosimetry methods for gamma and X-ray irradiation ...
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1.1 This guide outlines dosimetric procedures to be followed for the radiation-induced reproductive sterilization of live insects for use in pest management programs. The primary use of such insects is in the Sterile Insect Technique, where large numbers of reproductively sterile insects are released into the field to mate with and thus control pest populations of the same species. A secondary use of sterile insects is as benign hosts for rearing insect parasitoids. The procedures outlined in this guide will help ensure that insects processed with ionizing radiation from gamma, electron, or X-ray sources receive absorbed doses within a predetermined range. Information on effective dose ranges for specific applications of insect sterilization, or on methodology for determining effective dose ranges, is not within the scope of this guide.
NOTE 1—Dosimetry is only one component of a total quality assurance program to ensure that irradiated insects are adequately sterilized and fully competitive or otherwise suitable for their intended purpose.
1.2 This guide provides information on dosimetry for the irradiation of insects for these types of irradiators: selfcontained dry-storage 137Cs or 60Co irradiators, self-contained low-energy X-ray irradiators (maximum processing energies from 150 to 300 keV), large-scale gamma irradiators, and electron accelerators (electron and X-ray modes).
NOTE 2—Additional, detailed information on dosimetric procedures to be followed in installation qualification, operational qualification, performance qualification, and routine product processing can be found in ISO/ASTM Practices 51608 (X-ray [bremsstrahlung] facilities processing at energies over 300 keV), 51649 (electron beam facilities), 51702 (large-scale gamma facilities), and 52116 (self-contained dry-storage gamma facilities), and in Ref (1)2 (self-contained X-ray facilities).
1.3 The absorbed dose for insect sterilization is typicall...

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 other material...
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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 safety and he...

SIGNIFICANCE AND USE
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).
Dose Calculation—Absorbed-dose calculations may be performed for a variety of photon/electron environments and irradiator geometries.
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.
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).
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).
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 references (3-9).
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.
Verification—Verification is ...
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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 General purpose software packages are available for the calculation of the transport of charged and/or uncharged particles and photons 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 experience and also the inherent limitati...

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1.1 This guide describes several dosimetry systems and methods suitable for the documentation of the irradiation of product transported as fluid or in a fluidized bed.
1.2 The sources of penetrating ionizing radiation included in this guide are electron beams, x-rays (bremsstrahlung) and gamma rays.
1.3 Absorbed doses from 10 to 100,000 gray are considered, including applications such as disinfestation, disinfection, bioburden reduction, sterilization, crosslinking and graft modification of products, particularly powders and aggregates.
1.4 This guide does not purport to address the safety concerns, if any, associated with the use of fluidized beds and streams incorporating sources of ionizing radiation. It is the responsibility of the user of this guide to establish appropriate safety and health practices and to determine compliance with regulatory limitations prior to use.

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 determine the effectiveness of the radiation process, estimate the absorbed-dose distribution in product, or supplement and/or complement dosimetry measurements.
1.2 Radiation processing is an evolving field and annotated examples are provided in 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 in the energy range of 0.1 to 25 MeV.
1.4 The mathematical methods described include Monte Carlo, point kernel, discrete ordinate, semi-empirical and empirical methods.
1.5 General purpose software packages are available for the calculation of the transport of charged and/or neutral particles and photons 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, energetic electrons from particle accelerators, or bremsstrahlung 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.
Note 1—The user is urged to apply these predictive techniques while being aware of the need for experience and also the inherent limitations of both the method and the available software. Information pertaining to availability and updates to codes for modeling radiation transport, courses, workshops and meetings can be found in . For a basic understanding of radiation physics and a brief overview of method selection, refer to .
1.7 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory requirements prior to use.

SIGNIFICANCE AND USE
4.1 This guide is intended to provide direction on dosimetry for experiments in food and agricultural research, and on the reporting of dosimetry results. Research concerning the effectiveness of irradiation of food and agricultural products to achieve a defined benefit involves very different absorbed-dose specifications from one study and one product to another. For example, the absorbed dose required to sterilize fruit flies is much lower than the doses required to inactivate some bacterial pathogens in meat, or to decontaminate spices.
NOTE 4 - Examples of the relevant effects of irradiation include reduction of viable food-borne bacteria, viruses and parasites and phytosanitary treatment (such as disinfestation of fruits and vegetables), prevention of sprouting, delay of ripening, and changes in product chemistry and quality. Further discussion of these effects is outside the scope of this guide. Refer to ASTM Guides F 1355, F 1356, F 1736 and F 1885.
4.2 Proper reporting of the irradiation aspect is important since the degree of biological effect may be a function of various factors such as the radiation source, the absorbed-dose rate, energy of the incident radiation, environmental effects during irradiation, and the type of incident radiation. This guide attempts to highlight the information, including the methodology and results of the absorbed-dose measurements, necessary for an experiment to be repeatable by other researchers.
NOTE 5 - Factors that may influence the response of agricultural products to ionizing radiation include genus, species, variety, vigor, life stage, initial quality, state of ripeness, temperature, moisture content, pH, packaging, shipping, and storage conditions. Although these factors are not discussed in this guide, they should be considered when planning experiments (see ASTM Guides F 1355, F 1356, F 1640, F 1736 and F 1885.
4.3 Ideally, an experiment should be designed to irradiate the sample as uniformly as possible. In...
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1.1 This guide covers the minimum requirements for dosimetry and absorbed-dose validation needed to conduct research on the irradiation of food and agricultural products. Such research includes establishment of the quantitative relationship between the absorbed dose and the relevant effects in these products. This guide also describes the overall need for dosimetry in such research, and in reporting of the results.
1.2 This guide is intended for use by research scientists in the food and agricultural communities, and not just scientists conducting irradiation research. It, therefore, includes more tutorial information than most other ASTM and ISO/ASTM dosimetry standards for radiation processing.
1.3 This guide is in no way intended to limit the flexibility of the experimenter in the experimental design. However, the radiation source and experimental set up should be chosen such that the results of the experiment will be beneficial and understandable to other scientists, regulatory agencies, and the food and agricultural communities.
1.4 The effects produced by ionizing radiation in biological systems depend on a large number of factors which may be physical, physiological, or chemical. Although not treated in detail in this guide, quantitative data of environmental factors that may affect the absorbed-dose response of dosimeters, such as temperature and moisture content in the food or agricultural products should be reported.
1.5 The overall uncertainty in the absorbed-dose measurement and the inherent absorbed-dose range within the specimen should be taken into account in the design of an experiment.
1.6 The guide covers research conducted using the following types of ionizing radiation: gamma rays, bremsstrahlung X-rays, and electron beams.
1.7 This guide does not include other aspects of radiation processing research, such as planning of the experimental design. Dosimetry must be considered as an integral part ...

SIGNIFICANCE AND USE
Dosimetric Techniques—The processes addressed here utilize a variety of techniques for the dynamic presentation of the product to the radiation source. This may involve gravitational flow or simple pneumatic transport about or past the radiation source. In the case of fluidized beds, the product may be presented to the radiation source while supported in a gaseous or liquid stream moving at relatively high velocities. This document provides a guide to the dosimetric techniques suitable for these processes.
Food Products—Food products may be treated with ionizing radiation, such as energetic electrons from accelerators or gamma rays from 60Co or 137Cs sources, or X-rays, for numerous purposes, including control of parasites and pathogenic microorganisms, insect disinfestation, growth and maturation inhibition, and shelf-life extension.  
Note 1—Food irradiation specifications usually include upper and lower limits of absorbed dose: a minimum to ensure the intended beneficial effect and a maximum to avoid product degradation. For a given application, one or both of these values may be prescribed by regulations that have been established on the basis of available scientific data. Therefore, it is necessary to determine the capability of an irradiation facility to process within these absorbed-dose limits prior to the irradiation of the food product. Once this capability is established, it may be necessary to monitor and record the dose range delivered to the product during each production run to verify compliance with the process specifications within a predetermined level of confidence.
Randomized Flow—In a stream of randomized flow; i.e. turbulent instead of laminar, variations occur which lead to a dose distribution for the particles entrained in the stream. The “idealized” maximum and minimum doses possible can be calculated based upon knowledge of the applied dose rate, the product dwell time in the irradiation cell and the product or bed thickness. The expe...
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1.1 This guide describes several dosimetry systems and methods suitable for the documentation of the irradiation of product transported as fluid or in a fluidized bed.
1.2 The sources of penetrating ionizing radiation included in this guide are electron beams, X-rays (bremsstrahlung) and gamma rays.
1.3 Absorbed doses from 10 to 100,000 gray are considered, including applications such as disinfestation, disinfection, bioburden reduction, sterilization, crosslinking and graft modification of products, particularly powders and aggregates.
1.4 This guide does not purport to address the safety concerns, if any, associated with the use of fluidized beds and streams incorporating sources of ionizing radiation. It is the responsibility of the user of this guide to establish appropriate safety and health practices and to determine compliance with regulatory limitations prior to use.
WITHDRAWN RATIONALE
This guide describes several dosimetry systems and methods suitable for the documentation of the irradiation of product transported as fluid or in a fluidized bed.
Formerly under the jurisdiction of Committee E61 on Radiation Processing, this guide was withdrawn in June 2016. This standard is being withdrawn without replacement because to the committees’ knowledge it is not used in the industry anymore.