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ASTM ISO/ASTM51539-05(2013)

(Main)

Standard Guide for Use of Radiation-Sensitive Indicators

Standard Guide for Use of Radiation-Sensitive Indicators

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.

General Information

Status
Historical
Publication Date
07-Aug-2013
ICS
17.240 - Radiation measurements
Technical Committee
E61 - Radiation Processing
Drafting Committee
E61.04 - Specialty Application
Current Stage
Ref Project

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ASTM ISO/ASTM51539-05(2013) - Standard Guide for Use of Radiation-Sensitive IndicatorsASTM ISO/ASTM51539-05(2013) - Standard Guide for Use of Radiation-Sensitive Indicators
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ASTM ISO/ASTM51539-05(2013) - Standard Guide for Use of Radiation-Sensitive Indicators
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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
ISO/ASTM 51539:2005 (Reapproved 2013)(E)
Standard Guide for
Use of Radiation-Sensitive Indicators
This standard is issued under the fixed designation ISO/ASTM 51539; the number immediately following the designation indicates the
year of original adoption or, in the case of revision, the year of last revision.
1. Scope (Bremsstrahlung) Irradiation Facilities for Food Process-
ing
1.1 This guide covers procedures for using radiation-
51608 Practice for Dosimetry in an X-ray (Bremsstrahlung)
sensitive indicators (referred to hereafter as indicators) in
Facility for Radiation Processing
radiation processing. These indicators may be labels, papers,
51649 Practice for Dosimetry in an Electron Beam Facility
inks or packaging materials which undergo a visual change
2 for Radiation Processing at Energies between 300 keV and
when exposed to ionizing radiation (1-5).
25 MeV
1.2 The purpose for using indicators is to determine visually
51702 Practice for Dosimetry in Gamma Facility for Radia-
whether or not a product has been irradiated, rather than to
tion Processing
measure different dose levels.
51939 Practice for Blood Irradiation Dosimetry
51940 Guide for Dosimetry for Sterile Insect Release Pro-
1.3 Indicators are not dosimeters and shall not be used as a
substitute for proper dosimetry. Information about dosimetry grams
systems for radiation processing is provided in other ASTM
2.3 International Commission on Radiation Units and Mea-
and ISO/ASTM documents (see ISO/ASTM Guide 51261).
surements (ICRU) Reports:
ICRU Report 85 Fundamental Quantities and Units for
1.4 This standard does not purport to address all of the
safety concerns, if any, associated with its use. It is the Ionizing Radiation
responsibility of the user of this standard to establish appro-
3. Terminology
priate safety and health practices and determine the applica-
bility of regulatory limitations prior to use.
3.1 Definitions:
3.1.1 dosimetry system—system used for determining ab-
2. Referenced documents
sorbed dose, consisting of dosimeters, measurement instru-
ments and their associated reference standards, and procedures
2.1 ASTM Standards:
for the system’s use.
E170 Terminology Relating to Radiation Measurements and
Dosimetry
3.1.2 indicator—see radiation-sensitive indicator.
2.2 ISO/ASTM Standards:
3.1.3 process load—volume of material with a specified
51204 Practice for Dosimetry in Gamma Irradiation Facili-
product loading configuration irradiated as a single entity.
ties for Food Processing
3.1.4 radiation-sensitive indicator—material such as coated
51261 Practice for Calibration of Routine Dosimetry Sys-
or impregnated adhesive-backed substrate, ink, coating or other
tems for Radiation Processing
materials which may be affixed to or printed on the process
51431 Practice for Dosimetry in Electron Beam and X-ray
loads, and which undergoes a visual change when exposed to
ionizing radiation.
3.1.4.1 Discussion—This visual change may be as observed
This guide is under the jurisdiction of ASTM Committee E61 on Radiation with the unaided eye or with an eye aid such as an optical filter.
Processing and is the direct responsibility of Subommittee E61.04 on Specialty
3.1.4.2 Discussion—In the past, radiation-sensitive indica-
Application, and is also under the jurisdiction of ISO/TC 85/WG 3.
tors have been referred to by different names (1-5) including
Current edition approved May 27, 2013. Published July 2013. Originally
ε1
label dosimeters, label indicators, indicator labels, dose
published as ASTM E 1539–93. Last previous ASTM edition E 1539–98 . ASTM
E 1539–93 was adopted by ISO in 1998 with the intermediate designation ISO
indicators, and radiation monitoring labels. ASTM Subcom-
15564:1998(E). The present International Standard ISO/ASTM
mittee E10.01 considers a label dosimeter to be fundamentally
51539:2005(2013)(E) replaces ISO 15544 and is a reapproval of the last previous
different from an indicator, and intends to define a label
edition ISO/ASTM 51539:2005(E).
The boldface numbers in parentheses refer to the bibliography at the end of this dosimeter as a type of routine dosimeter (that is, quantitative)
guide.
For referenced ASTM and ISO/ASTM standards, visit the ASTM website,
www.astm.org, or contact ASTM Customer Service at service@astm.org. For
Annual Book of ASTM Standards volume information, refer to the standard’s Available from the International Commission on Radiation Units and
Document Summary page on the ASTM website. Measurements, 7910 Woodmont Ave., Suite 800, Bethesda, MD 20814, USA.
© ISO/ASTM International 2023 – All rights reserved
ISO/ASTM 51539:2005 (2013)(E)
that is unique in that it is attached firmly to the product and can 5.6 Indicator materials may include, but are not limited to,
be read out without being removed from the product. coated or impregnated adhesive-backed substrates, inks and
coatings (1-5).
3.2 Definitions of other terms used in this standard that
pertain to radiation measurement and dosimetry may be found
6. Application
in ASTM Terminology E170. Definitions in ASTM E170 are
6.1 Indicators may be used to help ensure that the process
compatible with ICRU 85; that document, therefore, may be
load has been irradiated.
used as an alternative reference.
6.2 Indicators may be used to ensure segregation of irradi-
ated product from non-irradiated product within the radiation
4. Significance and use
processing facility.
4.1 Indicators may be used to show that products have been
6.3 In the event of interruption of the irradiation process,
exposed to a radiation source. They should be used only to
indicators attached to product may help to locate the specific
provide a qualitative indication of radiation exposure and may
zone of process interruption, thereby minimizing the amount of
be used to distinguish processed loads that have been irradiated
discarded product.
from unirradiated process loads.
6.4 Indicators may be used for monitoring multiple-sided
NOTE 1—The use of indicators does not eliminate th
...

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SIGNIFICANCE AND USE
4.1 The Fricke dosimetry system provides a reliable means for measurement of absorbed dose to water, based on a process of oxidation of ferrous ions to ferric ions in acidic aqueous solution by ionizing radiation (ICRU 80, PIRS-0815, (4)). In situations not requiring traceability to national standards, this system can be used for absolute determination of absorbed dose without calibration, as the radiation chemical yield of ferric ions is well characterized (see Appendix X3).  
4.2 The dosimeter is an air-saturated solution of ferrous sulfate or ferrous ammonium sulfate that indicates absorbed dose by an increase in optical absorbance at a specified wavelength. A temperature-controlled calibrated spectrophotometer is used to measure the absorbance.
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1.1 This practice covers the procedures for preparation, testing, and using the acidic aqueous ferrous ammonium sulfate solution dosimetry system to measure absorbed dose to water when exposed to ionizing radiation. The system consists of a dosimeter and appropriate analytical instrumentation. The system will be referred to as the Fricke dosimetry system. The Fricke dosimetry system may be used as either a reference standard dosimetry system or a routine dosimetry system.  
1.2 This practice is one of a set of standards that provides recommendations for properly implementing dosimetry in radiation processing, and describes a means of achieving compliance with the requirements of ISO/ASTM Practice 52628 for the Fricke dosimetry system. It is intended to be read in conjunction with ISO/ASTM Practice 52628.  
1.3 The practice describes the spectrophotometric analysis procedures for the Fricke dosimetry system.  
1.4 This practice applies only to gamma radiation, X-radiation (bremsstrahlung), and high-energy electrons.  
1.5 This practice applies provided the following are satisfied:  
1.5.1 The absorbed dose range shall be from 20 Gy to 400 Gy (1).2  
1.5.2 The absorbed dose rate does not exceed 106 Gy·s−1 (2).  
1.5.3 For radioisotope gamma sources, the initial photon energy is greater than 0.6 MeV. For X-radiation (bremsstrahlung), the initial energy of the electrons used to produce the photons is equal to or greater than 2 MeV. For electron beams, the initial electron energy is greater than 8 MeV.  
Note 1: The lower energy limits given are appropriate for a cylindrical dosimeter ampoule of 12 mm diameter. Corrections for displacement effects and dose gradient across the ampoule may be required for electron beams (3). The Fricke dosimetry system may be used at lower energies by employing thinner (in the beam direction) dosimeter containers (see ICRU Report 35).  
1.5.4 The irradiation temperature of the dosimeter should be within the range of 10 °C to 60 °C.  
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ASTM ISO/ASTM51939-22(Practice)
Standard Practice for Blood Irradiation Dosimetry

SIGNIFICANCE AND USE
4.1 Blood and blood components are irradiated to predetermined absorbed doses to inactivate viable lymphocytes to help prevent transfusion-induced graft-versus-host disease (GVHD) in certain immunocompromised patients and those receiving related-donor products (1, 2).9  
4.2 The assurance that blood and blood components have been properly irradiated is of crucial importance for patient health. This shall be demonstrated by means of accurate absorbed-dose measurements on the product, or in simulated product.  
4.3 Blood and blood components are usually irradiated using gamma radiation from 137Cs or 60Co sources, or X-radiation from X-ray units.  
4.4 Blood irradiation specifications include a lower limit of absorbed dose, and may include an upper limit or central target dose. For a given application, any of these values may be prescribed by regulations that have been established on the basis of available scientific data (see 2.6).  
4.5 For each blood irradiator, an absorbed-dose rate at a reference position within the canister is measured as part of irradiator acceptance testing using a reference-standard dosimetry system. That reference-standard measurement is used to establish operating parameters so as to deliver specified dose to blood and blood components.  
4.6 Absorbed-dose measurements are performed within the blood or blood-equivalent volume for determining the absorbed-dose distribution. Such measurements are often performed using simulated product (for example, polystyrene is considered blood equivalent for 137Cs photon energies).  
4.7 Dosimetry is part of a measurement management system that is applied to ensure that the radiation process meets predetermined specifications (see ISO/ASTM Practice 52628).  
4.8 Blood and blood components are usually irradiated in chilled or frozen condition. Care should be taken, therefore, to ensure that the dosimeters and radiation-sensitive indicators can be used under such temperature conditions.  
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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.  
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Standard Practice for Dosimetry in an X-Ray (Bremsstrahlung) Facility for Radiation Processing at Energies between 50 keV and 7.5 MeV

SIGNIFICANCE AND USE
4.1 A variety of products and materials are irradiated with X-radiation to modify their characteristics and improve the economic value or to reduce their microbial population for health-related purposes. Dosimetry requirements might vary depending on the type and end use of the product. Some examples of irradiation applications where dosimetry may be used are:  
4.1.1 Sterilization of health care products;  
4.1.2 Treatment of food for the purpose of parasite and pathogen control, insect disinfestation, and shelf life extension;  
4.1.3 Disinfection of consumer products;  
4.1.4 Cross-linking or degradation of polymers and elastomers;  
4.1.5 Curing composite material;  
4.1.6 Polymerization of monomers and oligomer and grafting of monomers onto polymers;  
4.1.7 Enhancement of color in gemstones and other materials;  
4.1.8 Modification of characteristics of semiconductor devices; and  
4.1.9 Research on materials effects of irradiation.
Note 3: Dosimetry with measurement traceability and with known measurement uncertainty is required for regulated irradiation processes, such as the sterilization of health care products and treatment of food. Dosimetry may be less important for other industrial processes, such as polymer modification, which can be evaluated by changes in the physical properties of the irradiated materials. Nevertheless, routine dosimetry may be used to monitor the reproducibility of the radiation process.  
4.2 Radiation processing specifications usually include a pair of absorbed-dose limits: a minimum value to ensure the intended beneficial effect and a maximum value that the product can tolerate while still meeting its functional or regulatory specifications. For a given application, one or both of these values may be prescribed by process specifications or regulations. Knowledge of the dose distribution within irradiated material is essential to help meet these requirements. Dosimetry is essential to the radiation process since it i...
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1.1 This practice outlines the dosimetric procedures to be followed during installation qualification, operational qualification, performance qualification and routine processing at an X-ray (bremsstrahlung) irradiator. Other procedures related to operational qualification, performance qualification and routine processing that may influence absorbed dose in the product are also discussed.
Note 1: Dosimetry is only one component of a total quality assurance program for adherence to good manufacturing practices used in radiation processing applications.
Note 2: ISO/ASTM Practices 51649, 51818 and 51702 describe dosimetric procedures for electron beam and gamma facilities for radiation processing.  
1.2 For radiation sterilization of health care products, see ISO 11137-1, Sterilization of health care products – Radiation – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices. In those areas covered by ISO 11137-1, that standard takes precedence.  
1.3 For irradiation of food, see ISO 14470, Food irradiation – Requirements for development, validation and routine control of the process of irradiation using ionizing radiation for the treatment of food. In those areas covered by ISO 14470, that standard takes precedence.  
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4.1 Standards such as ISO 11137-1 (radiation sterilization of health care products) and ISO 14470 (irradiation of food) contain requirements that dosimetry used in the development, validation, and routine control of the process shall have measurement traceability to national or international standards and shall have a known level of uncertainty. The magnitude of the measurement uncertainty is important for assessing the results of the measurement system.  
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4.2 Information on the range of achievable uncertainty values for specific dosimetry systems is given in the ISO/ASTM standards for the specific dosimetry systems. While the uncertainty values given in specific dosimetry standards are achievable, it should be noted that both smaller and larger uncertainty values might be obtained depending on measurement conditions and instrumentation. For more information, see also ISO/ASTM 52628.  
4.3 This guide uses the methodology adopted by the GUM for estimating uncertainties in measurements (see 2.4). Therefore, components of uncertainty are evaluated as either Type A uncertainty or Type B uncertainty.  
4.3.1 Quantifying individual components of uncertainty may assist the user in identifying actions to reduce the combined measurement uncertainty.  
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SCOPE
1.1 This standard provides guidance on the use of concepts described in the JCGM (Joint Committee for Guides in Metrology) Evaluation of Measurement Data – Guide to the Expression of Uncertainty in Measurement (GUM) to estimate the uncertainties in the measurement of absorbed dose in radiation processing.  
1.2 Methods are given for identifying, evaluating, and estimating the components of measurement uncertainty associated with the use of dosimetry systems, and for calculating combined standard measurement uncertainty and expanded uncertainty of dose measurements based on the GUM methodology.  
1.3 Examples are given on how to develop a measurement uncertainty budget and a statement of uncertainty.  
1.3.1 Key components of uncertainty are derived as part of the derivation of the uncertainty budget. This standard identifies which components of uncertainty are carried forward as part of other analyses (e.g., assessment of process capability and process targets, and process variability), and which components from other standards are brought forward into this standard (e.g., precision of the dose measurement, calibration curve fit, and indirect measurement of dose).  
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ASTM ISO/ASTM51649-22(Practice)
Standard Practice for Electron Beam Radiation Processing at Energies Between 300 keV and 25 MeV

SIGNIFICANCE AND USE
4.1 Various products and materials are routinely irradiated at pre-determined doses at electron beam facilities to preserve or modify their characteristics. Dosimetry requirements may vary depending on the radiation process and end use of the product. A partial list of processes where dosimetry may be used is given below.  
4.1.1 Polymerization of monomers and grafting of monomers onto polymers,  
4.1.2 Cross-linking or degradation of polymers,  
4.1.3 Curing of composite materials,  
4.1.4 Sterilization of health care products,  
4.1.5 Disinfection of consumer products,  
4.1.6 Food irradiation (parasite and pathogen control, insect disinfestation, and shelf-life extension),  
4.1.7 Control of pathogens and toxins in drinking water,  
4.1.8 Control of pathogens and toxins in liquid or solid waste,  
4.1.9 Modification of characteristics of semiconductor devices,  
4.1.10 Color enhancement of gemstones and other materials, and  
4.1.11 Research on radiation effects on materials.  
4.2 Dosimetry is used as a means of monitoring the irradiation process.
Note 2: Dosimetry with measurement traceability and known uncertainty is required for regulated radiation processes such as sterilization of health care products (see ISO 11137-1 and Refs (1-36)) and preservation of food (see ISO 14470 and Ref (4)). It may be less important for other processes, such as polymer modification, which may be evaluated by changes in the physical and chemical properties of the irradiated materials. Nevertheless, routine dosimetry may be used to monitor the reproducibility of the treatment process.
Note 3: Measured dose is often characterized as absorbed dose in water. Materials commonly found in single-use disposable medical devices and food are approximately equivalent to water in the absorption of ionizing radiation. Absorbed dose in materials other than water may be determined by applying conversion factors (5, 6).  
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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.  
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Standard Practice for Use of an Alanine-EPR Dosimetry System

SIGNIFICANCE AND USE
4.1 The alanine-EPR dosimetry system provides a means for measuring absorbed dose. It is based on the measurement of specific stable free radicals in crystalline alanine generated by ionizing radiation.  
4.2 Alanine-EPR dosimetry systems are used in reference- or transfer-standard or routine dosimetry systems in radiation applications that include: sterilization of medical devices and pharmaceuticals, food irradiation, polymer modifications, medical therapy and radiation damage studies in materials (1, 13-15).
SCOPE
1.1 This practice covers dosimeter materials, instrumentation, and procedures for using the alanine-EPR dosimetry system to measure the absorbed dose in the photon or electron radiation processing of materials. The alanine system is based on electron paramagnetic resonance (EPR) spectroscopy of free radicals derived from the amino acid alanine.2  
1.2 The alanine dosimeter is classified as a type I dosimeter as it is affected by individual influence quantities in a well-defined way that can be expressed in terms of independent correction factors (see ISO/ASTM Practice 52628). The alanine dosimeter may be used in either a reference standard dosimetry system or in a routine dosimetry system.  
1.3 This document is one of a set of standards that provides recommendations for properly implementing dosimetry in radiation processing, and describes a means of achieving compliance with the requirements of ISO/ASTM 52628 “Practice for Dosimetry in Radiation Processing” for alanine dosimetry system. It should be read in conjunction with ISO/ASTM 52628.  
1.4 This practice covers the use of alanine-EPR dosimetry systems under the following conditions:  
1.4.1 The absorbed dose range is between 0.001 kGy and 150 kGy.  
1.4.2 The absorbed dose rate is up to 1 × 102 Gy s-1 for continuous radiation fields and up to 3 × 1010 Gy s-1 for pulsed radiation fields (1-4).3  
1.4.3 The radiation energy for photons and electrons is between 0.1 MeV and 30 MeV (1, 2, 5-8).  
1.4.4 The irradiation temperature is between –78 °C and +70 °C (2, 9-12).  
1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
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ASTM ISO/ASTM51702-13(2021)(Practice)
Standard Practice for Dosimetry in a Gamma Facility for Radiation Processing

SIGNIFICANCE AND USE
4.1 Various products and materials routinely are irradiated at predetermined doses in gamma irradiation facilities to reduce their microbial population or to modify their characteristics. Dosimetry requirements may vary depending upon the irradiation application and end use of the product. Some examples of irradiation applications where dosimetry may be used are:  
4.1.1 Sterilization of medical devices,  
4.1.2 Treatment of food for the purpose of parasite and pathogen control, insect disinfestation, and shelf life extension,  
4.1.3 Disinfection of consumer products,  
4.1.4 Cross-linking or degradation of polymers and elastomers,  
4.1.5 Polymerization of monomers and grafting of monomers onto polymers,  
4.1.6 Enhancement of color in gemstones and other materials,  
4.1.7 Modification of characteristics of semiconductor devices, and  
4.1.8 Research on materials effects.
Note 3: Dosimetry is required for regulated irradiation processes such as sterilization of medical devices and the treatment of food. It may be less important for other industrial processes, for example, polymer modification, which can be evaluated by changes in the physical and chemical properties of the irradiated materials.  
4.2 An irradiation process usually requires a minimum absorbed dose to achieve the intended effect. There also may be a maximum absorbed dose that the product can tolerate and still meet its functional or regulatory specifications. Dosimetry is essential to the irradiation process since it is used to determine both of these limits and to confirm that the product is routinely irradiated within these limits.  
4.3 The absorbed-dose distribution within the product depends on the overall product dimensions and mass, irradiation geometry, and source activity distribution.  
4.4 Before an irradiation facility can be used, it must be qualified to determine its effectiveness in reproducibly delivering known, controllable absorbed doses. This involves testing the pro...
SCOPE
1.1 This practice outlines the installation qualification program for an irradiator and the dosimetric procedures to be followed during operational qualification, performance qualification, and routine processing in facilities that process products with ionizing radiation from radionuclide gamma sources to ensure that product has been treated within a predetermined range of absorbed dose. Other procedures related to operational qualification, performance qualification, and routine processing that may influence absorbed dose in the product are also discussed.
Note 1: Dosimetry is only one component of a total quality assurance program for adherence to good manufacturing practices used in radiation processing applications.
Note 2: ISO/ASTM Practices 51818 and 51649 describe dosimetric procedures for low and high enery electron beam facilities for radiation processing and ISO/ASTM Practice 51608 describes procedures for X-ray (bremsstrahlung) facilities for radiation processing.  
1.2 For the radiation sterilization of health care products, see ISO 11137-1. In those areas covered by ISO 11137-1, that standard takes precedence.  
1.3 This document is one of a set of standards that provides recommendations for properly implementing and utilizing dosimetry in radiation processing. It is intended to be read in conjunction with ASTM Practice E2628.  
1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization...

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ASTM ISO/ASTM51650-21(Practice)
Standard Practice for Use of a Cellulose Triacetate Dosimetry System

SIGNIFICANCE AND USE
4.1 The CTA dosimetry system provides a means for measuring absorbed dose based on a change in optical absorbance in the CTA dosimeter following exposure to ionizing radiation (2-10).  
4.2 CTA dosimetry systems are commonly used in industrial radiation processing, for example in the modification of polymers and sterilization of health care products.  
4.3 CTA dosimeter film can be particularly useful in absorbed dose mapping because it is available in a reel of 100 m whereby the user can cut any length of strip for use. When the CTA film is measured using a strip measurement device with a narrow distance interval (for example, 2 mm), it can provide high resolution results in a linear direction.  
4.4 CTA is used to measure relative dose such as depth dose profiles in electron beam and reference phantom tests to assess irradiator changes in gamma.  
4.5 When CTA is used as a routine monitoring dosimeter the user must take into consideration the effects of the multiple influence quantities that can affect the result and use appropriate techniques, as discussed herein, for characterizing and mitigating such influences and understanding their contribution to measurement uncertainty. Without such effort the dosimetry system may not meet the user’s requirements for dosimetric release of some types of products (for example, health care products).
SCOPE
1.1 This is a practice for using a cellulose triacetate (CTA) dosimetry system to measure absorbed dose in materials irradiated by photons or electrons in terms of absorbed dose to water. CTA is used as a routine dosimetry system or used for relative dose measurements (that is, non-traceable dose measurements).  
1.2 The CTA dosimeter is classified as a type II dosimeter on the basis of the complex effect of influence quantities on its response (see ISO/ASTM Practice 52628).  
1.3 This document is one of a set of standards that provides recommendations for properly implementing dosimetry in radiation processing, and describes a means of achieving compliance with the requirements of ISO/ASTM 52628 “Practice for Dosimetry in Radiation Processing” for a CTA dosimetry system. It is intended to be read in conjunction with ISO/ASTM 52628.  
1.4 This practice covers the use of CTA dosimetry systems under the following conditions:  
1.4.1 The absorbed dose range is 10 kGy to 300 kGy.
Note 1: The dosimeter film irradiated to doses exceeding 200 kGy becomes brittle to some degree and must be handled with care. This may limit the practical dose range depending on the type of testing and handling required.  
1.4.2 The absorbed-dose rate range is 3 Gy/s to 4 ×1010 Gy·s (1).2  
1.4.3 The photon energy range is 0.1 to 50 MeV.  
1.4.4 The electron energy range is 0.2 to 50 MeV.  
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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ASTM ISO/ASTM51956-21(Practice)
Standard Practice for Use of a Thermoluminescence-Dosimetry System (TLD System) for Radiation Processing

SIGNIFICANCE AND USE
4.1 In radiation processing, TLDs are mainly used in the irradiation of blood products (see ISO/ASTM Practice 51939) and insects for sterile insect release programs (see ISO/ASTM Guide 51940). TLDs may also be used in other radiation processing applications such as the sterilization of medical products, food irradiation, modification of polymers, irradiation of electronic devices, and curing of inks, coatings and adhesives. (See ISO/ASTM Practices 51608, 51649, and 51702.)  
4.2 For radiation processing, the absorbed-dose range of interest is from 1 Gy to 100 kGy. Some TLDs can be used in applications requiring much lower absorbed doses (for example, for personnel dosimetry), but such applications are outside the scope of this practice. Examples of TLDs and applicable dose ranges are given in Table 1. Information on various types of TLDs and their applications can be found in Refs (1-10).7 (A) This table is taken from Ref (6). Ranges are approximate, and may vary with batch. Supralinearity refers to a region where the slope of the response versus dose curve is greater than that for the linear region.  
4.3 Information on other dosimetry systems used for radiation processing can be found in ICRU Report 80.
SCOPE
1.1 This practice covers procedures for the use of thermoluminescence dosimeters (TLDs) to measure the absorbed dose in materials irradiated by photons or electrons in terms of absorbed dose to water. Thermoluminescence-dosimetry systems (TLD systems) are generally used as routine dosimetry systems.  
1.2 The thermoluminescence dosimeter (TLD) is classified as a type II dosimeter on the basis of the complex effect of influence quantities on the dosimeter response. See ISO/ASTM Practice 52628.  
1.3 This document is one of a set of standards that provides recommendations for properly implementing dosimetry in radiation processing, and describes a means of achieving compliance with the requirements of ISO/ASTM 52628 “Practice for Dosimetry in Radiation Processing” for a TLD system. It is intended to be read in conjunction with ISO/ASTM 52628.  
1.4 This practice covers the use of TLD systems under the following conditions:  
1.4.1 The absorbed-dose range is from 1 Gy to 10 kGy.  
1.4.2 The absorbed-dose rate is between 1 × 10-2 and 1 × 1010 Gy s-1.  
1.4.3 The radiation-energy range for photons and electrons is from 0.1 to 50 MeV.  
1.5 This practice does not cover measurements of absorbed dose in materials subjected to neutron irradiation.  
1.6 This practice does not cover procedures for the use of TLDs for determining absorbed dose in radiation-hardness testing of electronic devices or for clinical dosimetry. Procedures for the use of TLDs for radiation-hardness testing are given in ASTM Practice E668. Procedures for use of TLDs in clinical dosimetry are given in ISO 28057.  
1.7 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.8 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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ASTM ISO/ASTM51401-21(Practice)
Standard Practice for Use of a Dichromate Dosimetry System

SIGNIFICANCE AND USE
4.1 The dichromate system provides a reliable means for measuring absorbed dose to water. It is based on a process of reduction of dichromate ions to chromic ions in acidic aqueous solution by ionizing radiation.  
4.2 The dosimeter is a solution containing silver and dichromate ions in perchloric acid in an appropriate container such as a sealed glass ampoule. The solution indicates absorbed dose by a change (decrease) in optical absorbance at a specified wavelength(s) ((3), ICRU Report 80). A calibrated spectrophotometer is used to measure the absorbance.
SCOPE
1.1 This practice covers the preparation, testing, and procedure for using the acidic aqueous silver dichromate dosimetry system to measure absorbed dose to water when exposed to ionizing radiation. The system consists of a dosimeter and appropriate analytical instrumentation. For simplicity, the system will be referred to as the dichromate system. The dichromate dosimeter is classified as a type I dosimeter on the basis of the effect of influence quantities. The dichromate system may be used as either a reference standard dosimetry system or a routine dosimetry system.  
1.2 This document is one of a set of standards that provides recommendations for properly implementing dosimetry in radiation processing, and describes a means of achieving compliance with the requirements of ISO/ASTM Practice 52628 for the dichromate dosimetry system. It is intended to be read in conjunction with ISO/ASTM Practice 52628.  
1.3 This practice describes the spectrophotometric analysis procedures for the dichromate system.  
1.4 This practice applies only to gamma radiation, X-radiation/bremsstrahlung, and high energy electrons.  
1.5 This practice applies provided the following conditions are satisfied:  
1.5.1 The absorbed dose range is from 2 × 10 3 to 5 × 104 Gy.  
1.5.2 The absorbed dose rate does not exceed 600 Gy/pulse (12.5 pulses per second), or does not exceed an equivalent dose rate of 7.5 kGy/s from continuous sources (1).2  
1.5.3 For radionuclide gamma sources, the initial photon energy shall be greater than 0.6 MeV. For bremsstrahlung photons, the initial energy of the electrons used to produce the bremsstrahlung photons shall be equal to or greater than 2 MeV. For electron beams, the initial electron energy shall be greater than 8 MeV.  
Note 1: The lower energy limits given are appropriate for a cylindrical dosimeter ampoule of 12 mm diameter. Corrections for displacement effects and dose gradient across the ampoule may be required for electron beams (2). The dichromate system may be used at lower energies by employing thinner (in the beam direction) dosimeter containers (see ICRU Report 35).  
1.5.4 The irradiation temperature of the dosimeter shall be above 0 °C and should be below 80 °C.  
Note 2: The temperature coefficient of dosimeter response is known only in the range of 5 to 50 °C (see 5.2). Use outside this range requires determination of the temperature coefficient.  
1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. Specific precautionary statements are given in 9.3.  
1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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