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ASTM ISO/ASTM52628-20

(Practice)

Standard Practice for Dosimetry in Radiation Processing

Standard Practice for Dosimetry in Radiation Processing

SIGNIFICANCE AND USE
4.1 Radiation processing of articles in both commercial and research applications may be carried out for a number of purposes. These include, for example, sterilization of health care products, reduction of the microbial populations in foods and modification of polymers. The radiations used may be accelerated electrons, gamma-radiation from radionuclide sources such as cobalt-60, or X-radiation.  
4.2 To demonstrate control of radiation processes that are dependent on the delivery of a known dose, the absorbed dose must be measured using a dosimetry system, the calibration of which, is traceable to appropriate national or international standards. The radiation-induced change in the dosimeter is evaluated and related to absorbed dose through calibration. Dose measurements required for particular processes are described in other standards referenced in this practice.
SCOPE
1.1 This practice describes the basic requirements that apply when making absorbed dose measurements in accordance with the ASTM E61 series of dosimetry standards. In addition, it provides guidance on the selection of dosimetry systems and directs the user to other standards that provide specific information on individual dosimetry systems, calibration methods, uncertainty estimation and radiation processing applications.  
1.2 This practice applies to dosimetry for radiation processing applications using electrons or photons (gamma- or X-radiation).  
1.3 This practice addresses the minimum requirements of a measurement management system, but does not include general quality system requirements.  
1.4 This practice does not address personnel dosimetry or medical dosimetry.  
1.5 This practice does not apply to primary standard dosimetry systems.  
1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.

General Information

Status
Published
Publication Date
14-Feb-2020
ICS
17.240 - Radiation measurements
Technical Committee
E61 - Radiation Processing
Drafting Committee
E61.01 - Dosimetry
Current Stage
Ref Project

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ASTM ISO/ASTM52628-20 - Standard Practice for Dosimetry in Radiation Processing
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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.
ISO/ASTM 52628:2020(E)
Standard Practice for
1
Dosimetry in Radiation Processing
This standard is issued under the fixed designation ISO/ASTM 52628; the number immediately following the designation indicates the
year of original adoption or, in the case of revision, the year of last revision.
Note—To keep year dates consistent, this 2020 edition is a re-issue of ISO/ASTM 52628-19, which was
inadvertently published before ISO formal approval. It is technically identical with the exception of the year date.
INTRODUCTION
The use of ionizing radiation for the treatment of commercial products such as the sterilization of healthcare
products, the reduction of microbial contamination in food or the modification of polymers is referred to as radiation
processing. The types of radiation used may be gamma radiation (typically from cobalt-60 sources), X-radiation or
accelerated electrons.
In some applications, it is necessary to ensure that the specified absorbed dose is applied. In these cases, the
absorbed dose must be measured, and measurement systems have been developed for this purpose. Much of the
developmentofthesesystemsrestsontheearlydevelopmentofdosimetrysystemsforpersonnelradiationprotection
and for medical treatment. However, the absorbed doses used in radiation processing are generally higher, ranging
from ~10 Gy up to 100 kGy or more and new dosimetry systems have been developed for measurements of these
doses.
Note that the terms “dose” and “absorbed dose” are used interchangeably in this standard (see 3.1.1).
The dose measurements required in radiation processing concern characterization of radiation facilities in
installation qualification (IQ) and operational qualification (OQ), measurement of dose distribution in irradiated
products in performance qualification (PQ) and routine monitoring of the irradiation process.
The literature is abundant with articles on dosimeters for radiation processing, and guidelines and standards have
been written by several organizations (the International Atomic Energy Agency (IAEA) and the International
CommissiononRadiationUnitsandMeasurements(ICRU),forexample)fortheoperationofthedosimetrysystems
and for their use in the characterization and validation of the radiation processing applications. In particular, ICRU
Report 80 provides information on the scientific basis and historical development of many of the systems in current
use.
ASTM Subcommittee E10.01 on Radiation Processing: Dosimetry andApplications was formed in 1984 initially
with the scope of developing standards for food irradiation, but its scope was widened to include all radiation
processing applications. The subcommittee, now Committee E61, has under its jurisdiction approximately 30
standard practices and standard guides, collectively known as the E61 standards on radiation processing.Anumber
of these standards have been published as ISO/ASTM standards, thereby ensuring a wider international acceptance.
These practices and guides describe the dosimetry systems most commonly used in radiation processing, and the
dose measurements that are required in the validation and routine monitoring of the radiation processes. A current
list of the E61 standards on radiation processing is given in 2.1 and 2.2.
The development, validation and routine control of a radiation process comprise a number of activities, most of
which rely on the ability to measure the delivered dose accurately. It is therefore necessary that dose is measured
with traceability to national, or international, standards, and the uncertainty in measured dose is known, including
the effect of influence quantities. The E61 standards on radiation processing dosimetry serve to fulfill these
requirements.
The practices describing dosimetry systems have several common attributes, and there is a need to have one
general standard that can act as a common reference and that can be used as a basis for the selection of dosimetry
systems for defined tasks. ISO/ASTM Practice 52628 serves this purpose. It outlines general requirements for the
calibration and use of dosimetry systems and for the estimation of measurement uncertainties. Details relating to
each dosimetry system are found in the respective standards and each of these refer to ISO/ASTM Practice 52628
for the general requirements.
© ISO/ASTM International 2020 – All rights reserved
1

---------------------- Page: 1 ----------------------
ISO/ASTM 52628:2020(E)
1. Scope 51261 Practice for Calibration of Routine Dosimetry Sys-
tems for Radiation Processing
1.1 Thispracticedescribesthebasicrequirementsthatapply
51275 Practice for Use of a Radiochromic Film Dosimetry
when making absorbed dose
...

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4.1 A variety of products and materials are irradiated with X-radiation to modify their characteristics and improve the economic value or to reduce their microbial population for health-related purposes. Dosimetry requirements might vary depending on the type and end use of the product. Some examples of irradiation applications where dosimetry may be used are:  
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1.1 This practice outlines the dosimetric procedures to be followed during installation qualification, operational qualification, performance qualification and routine processing at an X-ray (bremsstrahlung) irradiator. Other procedures related to operational qualification, performance qualification and routine processing that may influence absorbed dose in the product are also discussed.
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SIGNIFICANCE AND USE
4.1 Blood and blood components are irradiated to predetermined absorbed doses to inactivate viable lymphocytes to help prevent transfusion-induced graft-versus-host disease (GVHD) in certain immunocompromised patients and those receiving related-donor products (1, 2).9  
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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.  
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SCOPE
1.1 This document provides guidance on operational qualification (OQ) tests to meet the OQ requirements defined in ISO 11137-1, ISO 14470, ISO/ASTM 51702, and ISO/ASTM 52303 for gamma irradiators.  
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1.5 Many calculations in this guide were completed using Microsoft Excel (for example, ANOVA, t-test, p-value), but numerous other software tools are commercially available.  
1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
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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).  
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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.  
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1.3 This guide covers the calculation of radiation transport of electrons and photons with energies up to 25 MeV.  
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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.  
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SIGNIFICANCE AND USE
4.1 Control charts are the primary process monitoring tool in SPC for radiation processing. The general objectives of implementing a SPC program with control charts are to:  
4.1.1 Increase knowledge of the process,  
4.1.2 Control the process to provide a targeted or required process output,  
4.1.3 Reduce variation of the process output or in other ways improve the performance of a process, and  
4.1.4 Identify single process run results that are outside of established control limits but may be within the USL and LSL limits.  
4.2 These objectives when achieved:  
4.2.1 Reduce costs through reduction of losses due to scrap, rework, and investigation time,  
4.2.2 Improve consistency of the process output,  
4.2.3 Facilitate preventive process adjustments, and  
4.2.4 Provide evidence of accurate process targeting and process performance; state of statistical control.
SCOPE
1.1 This document provides guidance for the statistical analysis of the irradiation process from dosimetric data.  
1.2 This document is one of a set of guides and practices that provide recommendations for properly implementing dosimetry in radiation processing. It is intended to be read in conjunction with ISO/ASTM 52628 and ISO/ASTM 52303.  
1.3 This document employs a set of standard statistical methods and is intended to be read in conjunction with Practice E2586, Practice E2281, Practice E2587, and ASTM Manual MNL72.  
1.4 This guide is applicable to high-energy electron beam, X-ray and gamma-ray irradiation processes.  
1.5 This document assumes user knowledge of statistics, radiation processing, and radiation dosimetry. (See Annex A6)  
1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
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SIGNIFICANCE AND USE
4.1 The radiochromic optical waveguide dosimetry system provides a means of measuring absorbed dose in materials. Under the influence of ionizing radiation such as photons, chemical reactions take place in the radiochromic optical waveguide creating and/or modifying optical absorbance bands in the visible region of the spectrum. Optical response is determined at selected wavelengths using the equations in 3.1.4. Examples of appropriate wavelengths for the analysis for specific dosimetry systems are provided by their manufacturers and in Refs (1-5).  
4.2 These dosimetry systems commonly are applied in the industrial radiation processing of a variety of products, for example, the sterilization of medical devices and radiation processing of foods (4-6).
Note 1: For additional information on dosimetry systems used in radiation processing, see ICRU Report 80.
SCOPE
1.1 This is a practice for using a radiochromic optical waveguide dosimetry system to measure absorbed dose in materials irradiated by photons and high energy electrons in terms of absorbed dose to water. The radiochromic optical waveguide dosimetry system is generally used as a routine dosimetry system.  
1.2 The optical waveguide dosimeter is classified as a Type II dosimeter on the basis of the complex effect of influence quantities (see ISO/ASTM Practice 52628).  
1.3 This document is one of a set of standards that provides recommendations for properly implementing dosimetry in radiation processing, and describes a means of achieving compliance with the requirements of ISO/ASTM 52628 for an optical waveguide dosimetry system. It is intended to be read in conjunction with ISO/ASTM Practice 52628.  
1.4 This practice applies to radiochromic optical waveguide dosimeters that can be used within part or all of the specified ranges as follows:  
1.4.1 The absorbed dose range is from 1 Gy to 20 000 Gy.  
1.4.2 The absorbed dose rate is from 0.001 Gy/s to 1000 Gy/s.  
1.4.3 The radiation photon energy range is from 1 MeV to 10 MeV.  
1.4.4 The radiation electron energy range is from 3 MeV to 25 MeV.  
1.4.5 The irradiation temperature range is from –78 °C to +60 °C.  
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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Standard Practice for Calibration of Routine Dosimetry Systems for Radiation Processing

SIGNIFICANCE AND USE
4.1 Ionizing radiation is used to produce various desired effects in products. Examples of applications include the sterilization of medical products, microbial reduction, modification of polymers and electronic devices, and curing of inks, coatings, and adhesives (4).  
4.2 Absorbed-dose measurements, with statistical controls and documentation, are necessary to ensure that products receive the desired absorbed dose. These controls include a program that addresses requirements for calibration of routine dosimetry system.  
4.3 A routine dosimetry system calibration procedure as described in this document provides the user with a dosimetry system whose dose measurements are traceable to national or international standards for the conditions of use (see Annex A4). The dosimetry system calibration is part of the user’s measurement management system.
SCOPE
1.1 This practice specifies the requirements for calibrating routine dosimetry systems for use in radiation processing, including establishing measurement traceability and estimating uncertainty in the measured dose using the calibrated dosimetry system.
Note 1: Regulations or other directives exist in many countries that govern certain radiation processing applications such as sterilization of healthcare products and radiation processing of food requiring that absorbed-dose measurements be traceable to national or international standards (ISO 11137-1, Refs (1-3)2).  
1.2 The absorbed-dose range covered is up to 1 MGy.  
1.3 The radiation types covered are photons and electrons with energies from 80 keV to 25 MeV.  
1.4 This document is one of a set of standards that provides recommendations for properly implementing dosimetry in radiation processing, and describes a means of achieving compliance with the requirements of ASTM E2628 “Practice for Dosimetry in Radiation Processing” for the calibration of routine dosimetry systems. It is intended to be read in conjunction with ASTM E2628 and the relevant ASTM or ISO/ASTM standard practice for the dosimetry system being calibrated referenced in Section 2.  
1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
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Standard Guide for Performance Characterization of Dosimeters and Dosimetry Systems for Use in Radiation Processing

SIGNIFICANCE AND USE
4.1 Ionizing radiation produces physical or chemical changes in many materials that can be measured and related to absorbed dose. Materials with radiation-induced changes that have been thoroughly studied can be used as dosimeters in radiation processing.  
Note 3: The scientific basis for commonly used dosimetry systems and detailed descriptions of the radiation-induced interactions are given in ICRU Report 80.  
4.2 Before a material can be considered for use as a dosimeter, certain characteristics related to manufacture and measurement of its response to ionizing radiation need to be considered, including:  
4.2.1 the ability to manufacture batches of the material with evidence demonstrating a reproducible radiation-induced change,  
4.2.2 the availability of instrumentation for measuring this change, and  
4.2.3 the ability to take into account effects of influence quantities on the dosimeter response and on the measured absorbed-dose values.  
4.3 Dosimeter/dosimetry system characterization is conducted to determine the performance characteristics for a dosimeter/dosimetry system related to its capability for measuring absorbed dose. The information obtained from dosimeter/dosimetry system characterization includes the reproducibility of the measured absorbed-dose value, the useful absorbed-dose range, effects of influence quantities, and the conditions under which the dosimeters can be calibrated and used effectively.
Note 4: When dosimetry systems are calibrated under the conditions of use, effects of influence quantities may be minimized or eliminated, because the effects can be accounted for or incorporated into the calibration method (see ISO/ASTM Practice 51261).  
4.4 The influence quantities of importance might differ for different radiation processing applications and facilities. For references to standards describing different applications and facilities, see ISO/ASTM Practice 52628.  
4.5 Classification of a dosimeter as a type I dosimeter ...
SCOPE
1.1 This guide provides guidance on determining the performance characteristics of dosimeters and dosimetry systems used in radiation processing.  
1.2 This guide describes the influence quantities that might affect the performance of dosimeters and dosimetry systems and that should be considered during dosimeter/dosimetry system characterization.  
1.3 Users of this guide are directed to existing standards and literature for procedures to determine the effects from individual influence quantities and from combinations of more than one influence quantity.  
1.4 Guidance is provided regarding the roles of the manufacturers, suppliers, and users in the characterization of dosimeters and dosimetry systems.  
1.5 This guide does not address how the dosimeter/dosimetry system characterization information is to be used in radiation processing applications or in the calibration of dosimetry systems.
Note 1: For guidance on the use of dosimeter/dosimetry system characterization information for the selection and use of a dosimetry system, the user is directed to ISO/ASTM Practice 52628.
Note 2: For guidance on the use of dosimeter/dosimetry system characterization information for dosimetry system calibration, the user is directed to ISO/ASTM Practice 51261.  
1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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ASTM ISO/ASTM52116-13(2020)(Practice)
Standard Practice for Dosimetry for a Self-Contained Dry-Storage Gamma Irradiator

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

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