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

Dosimetry in Radiation Processing1
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
development of these systems rests on the early development of dosimetry systems for personnel radiation protection
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
Commission on Radiation Units and Measurements (ICRU), for example) for the operation of the dosimetry systems
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 and Applications 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. A number
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

ISO/ASTM 52628:2020(E)

1. Scope 51261 Practice for Calibration of Routine Dosimetry Sys-

1.1 This practice describes the basic requirements that apply tems for Radiation Processing
when making absorbed dose measurements in accordance with 51275 Practice for Use of a Radiochromic Film Dosimetry
the ASTM E61 series of dosimetry standards. In addition, it System
provides guidance on the selection of dosimetry systems and 51276 Practice for Use of a Polymethylmethacrylate Dosim-
directs the user to other standards that provide specific infor- etry System
mation on individual dosimetry systems, calibration methods, 51310 Practice for Use of a Radiochromic Optical Wave-
uncertainty estimation and radiation processing applications. guide Dosimetry System
51401 Practice for Use of a Dichromate Dosimetry System
1.2 This practice applies to dosimetry for radiation process- 51538 Practice for Use of the Ethanol-Chlorobenzene Do-
ing applications using electrons or photons (gamma- or simetry System
X-radiation). 51540 Practice for Use of a Radiochromic Liquid Dosimetry
1.3 This practice addresses the minimum requirements of a System
measurement management system, but does not include general 51607 Practice for Use of an Alanine-EPR Dosimetry Sys-
quality system requirements. tem
1.4 This practice does not address personnel dosimetry or 51608 Practice for Dosimetry in an X-Ray (Bremsstrahlung)
medical dosimetry. Facility for Radiation Processing at Energies between 50
keV and 7.5 MeV
1.5 This practice does not apply to primary standard dosim- 51631 Practice for Use of Calorimetric Dosimetry Systems
etry systems. for Electron Beam Dose Measurements and Dosimetry
1.6 This standard does not purport to address all of the System Calibration
safety concerns, if any, associated with its use. It is the 51649 Practice for Dosimetry in an Electron Beam Facility
responsibility of the user of this standard to establish appro- for Radiation Processing at Energies Between 300 keV
priate safety, health, and environmental practices and deter- and 25 MeV
mine the applicability of regulatory limitations prior to use. 51650 Practice for Use of a Cellulose Triacetate Dosimetry
System
2. Referenced documents 51702 Practice for Dosimetry in a Gamma Facility for
2.1 ASTM Standards:2 Radiation Processing
E2232 Guide for Selection and Use of Mathematical Meth- 51707 Guide for Estimation of Measurement Uncertainty in
ods for Calculating Absorbed Dose in Radiation Process- Dosimetry for Radiation Processing
ing Applications 51818 Practice for Dosimetry in an Electron Beam Facility
E3083 Terminology Relating to Radiation Processing: Do- for Radiation Processing at Energies Between 80 and 300
simetry and Applications keV
F1355 Guide for Irradiation of Fresh Agricultural Produce as 51900 Guide for Dosimetry in Radiation Research on Food
a Phytosanitary Treatment and Agricultural Products
F1356 Guide for Irradiation of Fresh, Frozen or Processed 51939 Practice for Blood Irradiation Dosimetry
Meat and Poultry to Control Pathogens and Other Micro- 51940 Guide for Dosimetry for Sterile Insect Release
organisms Programs
F1736 Guide for Irradiation of Finfish and Aquatic Inverte- 51956 Practice for Use of a Thermoluminescence-Dosimetry
brates Used as Food to Control Pathogens and Spoilage (TLD) System for Radiation Processing
Microorganisms 52116 Practice for Dosimetry for a Self-Contained Dry-
F1885 Guide for Irradiation of Dried Spices, Herbs, and Storage Gamma Irradiator
Vegetable Seasonings to Control Pathogens and Other 52303 Guide for Absorbed Dose Mapping in Radiation
Microorganisms Processing Facilities
52701 Guide for Performance Characterization of Dosim-
2.2 ISO/ASTM Standards:2 eters and Dosimetry Systems for Use in Radiation Pro-
51026 Practice for Using the Fricke Dosimetry System cessing
51205 Practice for Use of a Ceric-Cerous Sulfate Dosimetry
System 2.3 ISO Standards:3
ISO 11137-1 Sterilization of health care products – Radia-
tion – Part 1: Requirements for development, validation
1
and routine control of a sterilization process for medical
This practice is under the jurisdiction of ASTM Committee E61 on Radiation
Processing and is the direct responsibility of Subcommittee E61.01 on Dosimetry,
devices
and is also under the jurisdiction of ISO/TC 85/WG 3. ISO 11137-3 Sterilization of health care products – Radia-
Current edition approved September 2019. Published April 2020. Originally tion – Part 3: Guidance on dosimetric aspects of
published as ASTM E2628-09. The present International Standard ISO/ASTM
52628–2020(E) replaces ISO/ASTM 52628–13.
2
For referenced ASTM and ISO/ASTM standards, visit the ASTM website,
3
www.astm.org, or contact ASTM Customer Service at [email protected]. For Available from International Organization for Standardization (ISO), 1, ch. de
Annual Book of ASTM Standards volume information, refer to the standard’s la Voie-Creuse, Case postale 56, CH-1211, Geneva 20, Switzerland, https://
Document Summary page on the ASTM website. www.iso.org/contact-iso.html

2 © ISO/ASTM International 2020 – All rights reserved

 ISO/ASTM 52628:2020(E)

development, validation and routine control effect of influence quantities, for a dosimeter or dosimetry
ISO 10012 Measurement managements systems – Require- system under defined test conditions.
ments for measurement processes and measuring equip- 3.1.6 dosimeter response (indication)—reproducible, quan-
ment tifiable change produced in the dosimeter by ionizing radiation.
ISO 14470 Food irradiation – Requirements for the 3.1.6.1 Discussion—The dosimeter response value
development, validation and routine control of the process (indication), obtained from one or more measurements, is used
of irradiation using ionizing radiation for the treatment of in the estimation of the dosimetric quantity. The response value
food (indication) may be obtained from such measurements as
ISO/IEC 17025 General requirements for the competence of optical absorbance, intensity of EPR spectra, or electropoten-
testing and calibration laboratories tial between solutions.
2.4 International Commission on Radiation Units and Mea- 3.1.7 dosimetry—measurement of a dosimetric quantity by
surements (ICRU) Reports:4 the use of a dosimetry system.
ICRU Report 80 Dosimetry Systems for Use in Radiation
Processing 3.1.8 dosimetry system—interrelated elements used for mea-
ICRU Report 85a Fundamental Quantities and Units for suring a dosimetric quantity, including dosimeters, instruments
Ionizing Radiation and their associated reference standards, and procedures for
2.5 Joint Committee for Guides in Metrology (JCGM) their use.
Reports: 3.1.8.1 Discussion—As discussed in ICRU-85a, dosimetric
JCGM 100:2008, GUM , 1995, with minor corrections, quantities provide a physical measure to correlate with actual
Evaluation of measurement data – Guide to the Expres- or potential effects. They are products of radiometric quantities
sion of Uncertainty in Measurement5 and interaction coefficients. In calculations, the values of these
JCGM 200:2012, VIM , International vocabulary of metrol- quantities and coefficients must be known, while measure-
ogy – basic and general concepts and associated terms6 ments might not require this information. Dosimetric quantities
include air kerma, exposure and absorbed dose to a specified
3. Terminology material.
3.1 Definitions: 3.1.8.2 Discussion—In radiation processing applications the
3.1.1 absorbed dose (D)—quotient of dε̄ by dm, where dε̄ is quantity of interest is usually absorbed dose to water. Absorbed
the mean energy imparted by ionizing radiation to matter of dose to silicon might be used in semiconductor irradiations.
mass dm, thus 3.1.9 influence quantity—quantity that, in a direct
D 5 dε̄⁄dm measurement, does not affect the quantity that is actually
ICRU 85a measured, but affects the relation between the indication and
the measurement result. VIM
3.1.1.1 Discussion—The SI unit of absorbed dose is the gray
(Gy), where 1 gray is equivalent to the absorption of 1 joule per 3.1.9.1 Discussion—In dosimetry for radiation processing,
kilogram of the specified material (1 Gy = 1 J/kg). typical examples of influence quantities include radiation type
3.1.2 calibration—operation that, under specified and energy, irradiation temperature, dose rate and the time
conditions, in a first step, establishes a relation between the interval between irradiation and determination of the indication
quantity values with measurement uncertainties provided by of the dosimeter.
measurement standards and corresponding indications with 3.1.10 measurement management system—set of interre-
associated measurement uncertainties and, in a second step, lated or interacting elements necessary to achieve metrological
uses this information to establish a relation for obtaining a confirmation and continual control of measurement processes.
measurement result from an indication. VIM ISO 10012
3.1.3 calibration curve—expression of the relation between 3.1.10.1 Discussion—See 7.6 for further details.
indication and corresponding measured quantity value. VIM 3.1.11 (measurement) uncertainty—non-negative parameter
3.1.4 dosimeter—device that, when irradiated, exhibits a characterizing characterizing the dispersion of the quantity
quantifiable change that can be related to a dosimetric quantity values being attributed to a measurand, based on the informa-
using appropriate measurement instrument(s) and procedures. tion used. VIM
3.1.5 dosimeter characterization / dosimetry system 3.1.12 (metrological) traceability—property of a measure-
characterization—determination of performance ment result whereby the result can be related to a reference
characteristics, such as dose range, reproducibility and the through a documented unbroken chain of calibrations, each
contributing to the measurement uncertainty. VIM
3.1.13 primary standard dosimetry system —dosimetry sys-
4
Available from the International Commission on Radiation Units and tem that is designated or widely acknowledged as having the
Measurements, 7910 Woodmont Ave, Suite 800, Bethesda, MD 20815, USA.
5
Document produced by Working Group 1 of the Joint Committee for Guides in highest metrological qualities and whose value is accepted
Metrology (JCGM/WG 1). Available free of charge at the BIPM website (http:// without reference to other standards of the same quantity.
www.bipm.org).
6
Document produced by Working Group 2 of the Joint Committee for Guides in
3.1.14 radiation processing—intentional irradiation of prod-
Metrology (JCGM/WG 2). Available free of charge at the BIPM website (http:// ucts or materials to preserve, modify or improve their charac-
www.bipm.org). teristics.

© ISO/ASTM International 2020 – All rights reserved 3

ISO/ASTM 52628:2020(E)

3.1.15 reference standard dosimetry system—dosimetry 5. Dosimetry system requirements

system, generally having the highest metrological quality 5.1 Dosimetry system requirements are a necessary part of a
available at a given location or in a given organization, from measurement management system. The following requirements
which measurements made there are derived. shall be included as a minimum, but additional requirements
3.1.16 reference standard radiation field—calibrated radia- may be appropriate depending on the nature of the process.
tion field, generally having the highest metrological quality Guidance on these requirements is given in Section 7.
available at a given location or in a given organization, from 5.1.1 The selection and use of a specific dosimetry system in
which measurements made there are derived. a given application shall be justified and documented. The
3.1.17 routine dosimetry system—dosimetry system cali- justification shall take into account at least the following:
brated against a reference standard dosimetry system and used dose range
for routine absorbed dose measurements, including dose map- radiation type and energy
ping and process monitoring. effect of influence quantities
level of uncertainty
3.1.18 transfer standard dosimetry system—dosimetry sys- spatial resolution
tem used as an intermediary to calibrate other dosimetry 5.1.2 The dosimetry system shall be calibrated in accor-
systems. dance with the requirements of ISO/ASTM Practice 51261.
3.1.19 type I dosimeter—dosimeter of high metrological 5.1.3 The uncertainty associated with measurements made
quality, the response of which is affected by individual influ- with the selected dosimetry system shall be established and
ence quantities in a way that is well-defined and capable of documented. All dose measurements shall be accompanied by
expression in terms of independent correction factors. an estimate of uncertainty. See ISO/ASTM 51707, NPL Report
3.1.19.1 Discussion—See Section 6 for examples and fur- CIRM 297, GUM and NIST Technical Note 12978 for guid-
ther details. ance.
5.1.4 Documentation shall be established and maintained to
3.1.20 type II dosimeter—dosimeter, the response of which ensure compliance with the minimum requirements specified in
is affected by influence quantities in a complex way that cannot the ASTM or ISO/ASTM standard relevant to the specific
practically be expressed in terms of independent correction dosimetry system. The user’s quality system might be more
factors. detailed than these minimum requirements.
3.1.20.1 Discussion—See Section 6 for examples and fur-
ther details. 6. Classification
3.1.21 uncertainty budget—statement of a measurement 6.1 Classification of dosimeters and dosimetry systems in
uncertainty, of the components of that measurement the ASTM E61 series of dosimetry standards is based on two
uncertainty, and of their calculation and combination. VIM distinct criteria: (1) the inherent metrological properties of the
dosimeter (see 3.1.19 and 3.1.20), and (2) the field of applica-
3.2 Definitions of other terms used in this standard that
tion of the dosimetry system (see 3.1.15 and 3.1.17). These
pertain to radiation measurement and dosimetry may be found
classifications are important in both the selection and calibra-
in ASTM Terminology E3083. Definitions in ASTM E3083 are
tion of dosimetry systems.
compatible with ICRU Report 85a; that document, therefore,
may be used as an alternative reference. Where appropriate, 6.2 Classification of Dosimeters Based on Metrological
definitions used in this standard have been derived from, and Properties:
are consistent with, general metrological definitions given in 6.2.1 This classification of dosimeters is based on knowl-
the VIM. edge of their inherent metrological properties. The method of
measurement may be important in the classification (see
4. Significance and use below), but the classification does not include consideration of
the quality of the actual instrumentation used, or the quality of
4.1 Radiation processing of articles in both commercial and preparation (manufacture) of the dosimeter. For example,
research applications may be carried out for a number of acidic solutions of dichromate ions have certain inherent
purposes. These include, for example, sterilization of health properties in terms of their response to radiation and the effect
care products, reduction of the microbial populations in foods of irradiation temperature that means they are classified as type
and modification of polymers. The radiations used may be I dosimeters. The actual performance of a given dosimetry
accelerated electrons, gamma-radiation from radionuclide system based on dichromate dosimeters will depend, however,
sources such as cobalt-60, or X-radiation. on the quality of preparation of the dosimetric solution and the
4.2 To demonstrate control of radiation processes that are quality of the spectrophotometers used for optical absorbance
dependent on the delivery of a known dose, the absorbed dose measurement.
must be measured using a dosimetry system, the calibration of
which, is traceable to appropriate national or international 7
Sharpe, P., and Miller, A., “Guidelines for the Calibration of Routine Dosimetry
standards. The radiation-induced change in the dosimeter is Systems for use in Radiations Processing,” NPL Report CIRM 29, Teddington, UK,
2009.
evaluated and related to absorbed dose through calibration. 8
Taylor, B. N., and Kuyatt, C. E., “Guidelines for Evaluating and Expressing the
Dose measurements required for particular processes are de- Uncertainty of NIST Measurement Results,” NIST TN-1297, Gaithersburg, MD:
scribed in other standards referenced in this practice. NIST 1994.

4 © ISO/ASTM International 2020 – All rights reserved

 ISO/ASTM 52628:2020(E)

6.2.2 Knowledge of the inherent properties of a dosimeter is system with low uncertainty and with traceability to appropri-
important when selecting a dosimeter for a particular applica- ate national or international standards.
tion. For example, when selecting a dosimeter to be used to 6.3.1.2 Reference standard dosimetry systems may take the
transfer dose between radiation fields of differing temperatures, form of systems held at a given location or they may take the
it is essential to choose a dosimeter whose response can be form of transfer standard dosimetry systems operated by a
corrected for the effect of irradiation temperature, that is, a type national standards laboratory or by a laboratory accredited to
I dosimeter. ISO/IEC 17025. In the case of transfer standard dosimetry
6.2.3 In order for a dosimeter to be classified as a type I systems, dosimeters are sent to a facility for irradiation and
dosimeter, it must be possible to apply accurate, independent, then returned to the issuing laboratory for measurement. The
corrections to its response to account for the effects of relevant requirement to transport dosimeters without unduly increasing
influence quantities, such as temperature, dose rate, etc., or to measurement uncertainty restricts the type of dosimeter that
demonstrate that the influence quantity is not relevant and will can be used. Alanine/EPR, dichromate or ceric-cerous dosim-
not affect the dosimeter’s response. The magnitude of the etry systems are commonly used in this way.
correction, the range of values of the influence quantity over
6.3.1.3 A reference standard dosimetry system comprises
which it is applicable and the range of doses over which it is
dosimeters and the associated measurement equipment and
applicable are determined as part of dosimeter characterization
quality system documentation necessary to ensure traceability
(see 7.3). In classifying a dosimeter as a type I dosimeter, it
to appropriate national and international standards. The dosim-
may be necessary to specify the method of measurement. For
eter used in a reference standard dosimetry system is generally
example, free radicals produced in irradiated alanine can, in
a type I dosimeter, although there may be exceptions (see, for
principle, be measured by a number of different techniques,
example, ISO/ASTM 51631).
however, only the EPR technique has been shown to provide
the high metrological quality (precision and accuracy) neces- 6.3.1.4 The expanded uncertainty achievable with measure-
sary to classify alanine as a type I dosimeter. Examples of type ments made using a reference standard dosimetry system is
I dosimeters are given in Table 1. typically of the order of 3 % (k=2). In certain specific
6.2.4 The classification of a dosimeter as a type II dosimeter applications, for example the use of electrons of energy below
is based on the complexity of interaction between influence 1 MeV, practical limitations of the techniques may mean that
quantities, such as temperature and dose rate, which makes it the reference standard dosimetry systems have a larger uncer-
impractical to apply independent correction factors to the tainty.
dosimeter response. Examples of type II dosimeters are given NOTE 1—An expanded uncertainty derived by multiplying a combined
in Table 2. standard uncertainty by a coverage factor of k=2 provides a level of
6.3 Classification of Dosimetry Systems Based on the Field confidence of approximately 95 %. See ISO/ASTM 51707 and the GUM
for further details.
of Application:
6.3.1 Reference Standard Dosimetry Systems: 6.3.2 Routine Dosimetry Systems —The classification of a
6.3.1.1 The classification of a dosimetry system as a refer- dosimetry system as a routine dosimetry system is based on its
ence standard dosimetry system is based on its application. application, i.e. routine absorbed dose measurements, includ-
Reference standard dosimetry systems are used as standards to ing dose mapping and process monitoring. A routine dosimetry
calibrate the dosimetry systems that are used for routine system comprises dosimeters and the associated measurement
measurements. The uncertainty of the reference standard equipment and quality system documentation necessary to
dosimetry system will affect the uncertainty of the system being ensure traceability to appropriate national or international
calibrated and it is therefore important that the reference standards. The dosimeter used in a routine dosimetry system is
standard dosimetry system is of high metrological quality. In often a type II dosimeter, although type I dosimeters, such as
this context, the concept of high metrological quality implies a alanine, can also be used for routine dose measurements.

TABLE 1 Examples of type I dosimeters

Dosimeter Description Reference
Fricke solution Liquid solution of ferrous and ferric ions in 0.4 mol dm−3 ISO/ASTM 51026
sulfuric acid. Measured by spectrophotometry.

Alanine/EPR Pellet or film containing alanine. Measured by EPR spec- ISO/ASTM 51607
troscopy of radiation induced radical.

Dichromate Liquid solution of chromium ions in 0.1 mol dm−3 perchlo- ISO/ASTM 51401
ric acid. Measured by spectrophotometry.

Ceric-Cerous Sulphate Liquid solution of ceric and cerous ions in 0.4 mol dm−3 ISO/ASTM 51205
sulphuric acid. Measured by spectrophotometry or poten-
tiometry.

Ethanol Chlorobenzene (Classification Liquid solutions of various compositions containing chlo- ISO/ASTM 51538
dependent on solution composition and robenzene in ethanol. Measured by titration.
method of measurement)

© ISO/ASTM International 2020 – All rights reserved 5

ISO/ASTM 52628:2020(E)
TABLE 2 Examples of type II dosimeters
Dosimeter Description Reference
Calorimeter Assembly consisting of calorimetric body (absorber), ISO/ASTM 51631
thermal insulation, and temperature sensor with wiring.

Cellulose Triacetate Untinted cellulose triacetate (CTA) film. Measured by ISO/ASTM 51650
spectrophotometry.

Ethanol Chlorobenzene (Classification Liquid solution of various compositions containing chlo- ISO/ASTM 51538
dependent on solution composition and robenzene in ethanol. Measured by spectrophotometry or
method of measurement) oscillometry.

PMMA Specially developed PMMA materials. Measured by spec- ISO/ASTM 51276

trophotometry.

Radiochromic Film Specially prepared film containing dye precursors. Mea- ISO/ASTM 51275
sured by spectrophotometry.

Radiochromic Liquid Specially prepared solution containing dye precursors. ISO/ASTM 51540
Measured by spectrophotometry.

Radiochromic Optical Waveguide Specially prepared optical waveguide containing dye pre- ISO/ASTM 51310
cursors. Measured by spectrophotometry.

TLD A phosphor, alone, or incorporated in a material. Mea- ISO/ASTM 51956

sured by thermoluminescence.

TABLE 3 General dosimetry requirements for all radiation

6.3.2.1 The expanded uncertainty achievable with measure- processing applications
ments made using a routine dosimetry system is typically of the Dosimetry Radiation
Application Reference
order of 6 % (k=2), but can be greater or smaller depending on Requirements Type
the nature of the measurement, the analytical equipment and Dosimetry is Gamma ISO/ASTM 51702
required for
the skill of the operator. For example, the uncertainty of installation 300 keV ISO/ASTM 51649
measurements made using alanine dosimeters in gamma rays qualification (IQ), to 25 MeV
General operational electron
or megavoltage electron beams might be lower than 6 %, Industrial qualification, beam
whereas it might be higher than 6 % for processes involving Radiation (OQ),
electron beams below 1 MeV or X-rays below 500 keV. The Processing performance 80 to 300 ISO/ASTM 51818
qualification (PQ) keV elec-
measurement uncertainty for a given situation has to be and routine tron beam
determined by the development of a full uncertainty budget process
(see 7.5). monitoring X-Ray ISO/ASTM 51608

7. Guidance
TABLE 4 Dosimetry requirements for specific radiation
7.1 Dosimetry System Components: processing applications
7.1.1 A dosimetry system consists of a number of compo-
Application Dosimetry Requirements Reference
nents used in the measurement of absorbed dose. These include
Food Irradiation ISO 14470
the dosimeter, the instrumentation used and the written proce- Dosimetry is required in process
dures necessary for the operation of the system. Instrumenta- Medical Device definition, IQ (e-beam, X-ray), ISO 11137-1
tion not only includes the instrument used for measuring the Sterilization OQ, PQ and routine process
control
dosimeter response, but also ancillary instruments, such as Blood Irradiation ISO/ASTM 51939
thickness gauges and reference standard materials for assessing
instrument performance.
7.2 Dosimetry System Selection: dosimetry as used in a range of radiation processing applica-
7.2.1 The selection of a dosimetry system for a particular tions. There is some overlap in the scopes of a number of these
application is the responsibility of the user. standards, but the requirements in the standards listed in Table
7.2.2 Section 5.1.1 gives a list of factors that must, as a 4 always take precedence over those in the general standards
minimum, be taken into account when selecting a dosimetry listed in Table 3.
system, but careful consideration needs to be given to addi- 7.2.4 Summaries of the performance characteristics of do-
tional factors that may be relevant to the specific application. simeters are given in Annex A1, but for detailed information
Examples include pre- and post-irradiation stability, ease of use the relevant ASTM or ISO/ASTM practice should be con-
and ease of calibration. Safety related aspects, such as toxicity, sulted. Brief guidance on issues that need to be considered
might also be important, particularly with respect to the when selecting a dosimetry system is given below:
irradiation of foods. 7.2.4.1 Dose range—Doses used in radiation processing
7.2.3 Tables 3-6, inclusive, list ISO, ASTM and ISO/ASTM range from ~10 Gy to more than 100 kGy according to the
standards that give requirements or guidance, or both, on application. The relatively restricted operating range of many

6 © ISO/ASTM International 2020 – All rights reserved

 ISO/ASTM 52628:2020(E)
TABLE 5 Guidance for dosimetry in specific radiation processing dosimetry systems to some extent. The classification of dosim-
applications eters into types I and II is largely on the basis of the nature of
Application Dosimetry Requirements Reference the effect of influence quantities. In selecting a dosimeter, it is
Radiation Research Covers the minimum requirements ISO/ASTM essential to consider all influence quantities relevant to the
for dosimetry and absorbed-dose 51900
validation needed to conduct
application, assess whether their effects are significant and, if
research on the effects of so, whether the effects can be satisfactorily accounted for,
radiation on materials and products either by the application of correction factors, or by calibration
Sterile Insect Re- Outlines dosimetric procedures ISO/ASTM under the conditions of use.
lease Programs to be followed for the radiation 51940 7.2.4.4 Stability of dosimeter response—Pre- and post-
sterilization of live insects
for use in pest management
irradiation stability of the dosimeter response can be an
programs important consideration. Some dosimeters, such as Fricke
solution, exhibit a continuous increase in response before and
Irradiation using Self-Dosimetry is required ISO/ASTM
contained Dry- for operational qualification (OQ) 52116
after irradiation, that requires correction by the use of appro-
storage Gamma Irra- priate control samples, such as unirradiated dosimeters subject
diator to the same environmental conditions as the dosimeters used to
Radiation Steriliza- Described guidance for ISO 11137-1
measure dose. Other systems show changes in the dosimeter
tion of Health Care calibration, IQ, OQ, PQ and 11137-3 response with time after irradiation, that may require specifi-
Products and routine monitoring cation of the interval between irradiation and measurement.
Fresh Agricultural ASTM F1355 7.2.4.5 Level of uncertainty—A full assessment of both the
Produce as a Phy- measurement uncertainty necessary for the application and the
tosanitary Treatment measurement uncertainty achievable by a particular dosimetry
Fresh and Frozen ASTM F1356 system is an essential component of dosimetry system selection
Processed Meat and (see 7.5).
Poultry Products These standards outline the minimum re-
quirements for dosimetry and describe
7.2.4.6 Spatial resolution—Applications such as dose map-
Finfish and Aquatic absorbed-doses needed for specific effects ASTM F1736 ping in electron beams and the measurement of doses close to
Invertebrates Used interfaces, place requirements on the spatial resolution of the
as Food
dosimeter. Large dosimeters, such as liquids contained in
Dried Spices, Herbs ASTM F1885 ampoules, will only provide information on the mean dose to
and Vegetable Sea- the volume of solution. If resolution on a small (less than 1
sonings
mm) scale is required it may be necessary to use thin film
dosimeters. The achievable spatial resolution may be deter-
TABLE 6 Guidance on absorbed-dose mapping and mathematical
mined by the method of measurement, rather than the size of
methods the dosimeter. For example, large area dosimeters can be
Application Guidance Reference
scanned by small light beams, or a desktop scanner, to give
Radiation Processing Measuring absorbed dose distributions in ISO/ASTM
high spatial resolution in two dimensions.
products, materials or substances Guide
52303
7.3 Dosimeter/Dosimetry System Characterization:
7.3.1 Information on the general characteristics of a dosim-
Selection and Use of Describes different mathematical methods ASTM Guide eter or dosimetry system can be found in the literature and
Mathematical Meth- that may be used to calculate absorbed E2232
ods for Calculating dose and criteria for their selection as obtained from the manufacturer or supplier. Typically, tests
Absorbed Dose tools to complement routine dosimetry in would have been carried out under a range of defined condi-
some applications tions in which potential influence quantities were varied to
determine the magnitude of possible effects. ISO/ASTM Guide
52701 describes the influence quantities that need to be
dosimeters means that it is often not possible to use the same considered and sets out experimental techniques that can be
dosimetry system over the entire dose range of interest. The used to quantify the effects and their interactions. These tests
uncertainty associated with a dosimetry system may increase at will also provide information on the useful dose range of the
both the lower and upper extremes of its quoted dose range. dosimetry system and give an indication of the achievable
7.2.4.2 Radiation type and energy—Radiation processing uncertainty. This activity is generally referred to as dosimeter
applications utilize a range of radiation types including or dosimetry system characterization (see 3.1.5). Guidance is
X-radiation, gamma radiation and electrons with energies from also provided in ISO/ASTM Guide 52701 regarding the roles
below 100 keV to more than 10 MeV. The suitability of a of the manufacturers, suppliers, and users in the characteriza-
dosimetry system for a given type of radiation will depend on tion of dosimeters and dosimetry systems.
the physical form and size of the dosimeter and the ability to 7.3.2 Available information should be reviewed by the user
calibrate the system. The response of some dosimeters is and, if necessary, additional tests carried out to characterize
known to vary with both the type of radiation and the dose rate. performance under the specific conditions of use.
7.2.4.3 Influence quantities—Influence quantities, such as 7.3.3 The classification of a dosimeter as a type I dosimeter
temperature before, during and after irradiation, dose rate, or a type II dosimeter is made in this standard on the basis of
humidity and radiation type affect the performance of most characterization experiments and depends on the quantitative

© ISO/ASTM International 2020 – All rights reserved 7

ISO/ASTM 52628:2020(E)

nature of the effect of influence quantities and whether or not 7.5.3 An understanding of the components that contribute to
it is possible to make independent corrections. uncertainty is essential when assessing the significance of
7.3.4 It is important to differentiate between characteriza- measurements made during radiation processing. For example,
tion and calibration. (a) Characterization provides information in relative dose mapping the only significant component of
on the likely effect of influence quantities and is used in uncertainty may be dosimeter-to-dosimeter reproducibility,
dosimetry system selection and in determining the method of whereas in applications requiring traceable dose
calibration required. (b) Calibration is the operation used to measurements, it will be necessary to consider all components
determine the calibration curve of a given dosimetry system of uncertainty.
under the conditions of use, and is the responsibility of the user 7.5.4 Specific guidance on estimating uncertainty in radia-
of the dosimetry system (see ISO/ASTM Practice 51261). tion processing dosimetry can be found in ISO/ASTM 51707
7.4 Dosimetry System Calibration: and NPL Report CIRM 29.7 More general guidance can be
7.4.1 All dosimetry equipment requires either calibration found in the GUM and, for example, NIST Technical Note
traceable to appropriate standards or performance checks to 1297.8
verify its operation. Requirements for calibration of dosimetry
systems used in radiation processing are given in ISO/ASTM 7.6 Measurement Management Systems:
Practice 51261. 7.6.1 Many of the aspects discussed previously in this
7.4.2 In the majority of radiation processing applications it section are essential elements of a wider measurement man-
is necessary to demonstrate that dose measurements are trace- agement system that encompasses all of the quality system
able to recognized national or international standards. There aspects associated with the measurement process. The more
are a few applications where only relative dose measurements general quality system aspects are outside the scope of the
are carried out, for example, beam width measurements, that ASTM E61 series of dosimetry standards, but guidance and
may not require traceability. requirements can be found in documents such as ISO 10012,
7.4.3 Many calibration laboratories maintain their absorbed which can be used to meet the requirements for measurement
dose standard as a well characterized reference standard in ISO 9000 based quality systems. The definition of measure-
radiation field, rather than a reference standard dosimetry ment management system (3.1.10) is taken from ISO 10012.
system. Typically, this consists of a Co-60 irradiator in which 7.6.2 The establishment of a measurement management
both the source and sample geometry are well defined. The system is an essential component in the demonstration that dose
dose rate on a given date is determined using either primary
measurements are traceable to recognized national or interna-
standard or reference standard dosimetry systems. The dose for
tional standards. The measurement management system must
subsequent sample irradiations is then calculated based on the
include all aspects of the measurement process, including
source decay and accurate timing of the irradiation.
selection of a method, calibration, detailed instructions for use,
7.4.4 Calibrations of dosimetry systems are most commonly
methods for establishing uncertainty, staff training, record
made in terms of absorbed dose to water, but absorbed dose to
keeping, action to be taken in the event of non-conformities,
other materials might be used, for example, absorbed dose to
silicon in the case of semiconductor irradiations. management responsibilities, amongst others.
7.6.3 Another standard, ISO/IEC 17025, covers require-
7.5 Dosimetry Uncertainties: ments to be met by calibration laboratories. The term approved
7.5.1 All dose measurements need to be accompanied by an dosimetry calibration laboratory used in the ASTM E61 series
estimate of uncertainty. of standards generally refers to a national metrology institute or
7.5.2 All known or potentially significant components of
a laboratory accredited to ISO/IEC 17025. ISO/IEC 17025
uncertainty should be included in the estimate, including those
gives quality management requirements as well as require-
arising from calibration, dosimeter response reproducibility,
ments for a measurement management system and for the
instrument stability and the effect of influence quantities. A full
technical expertise of the laboratory.
quantitative analysis of components of uncertainty is referred
to as an uncertainty budget and is often presented in the form
of a table. Typically, the uncertainty budget will identify all 8. Keywords
significant components of uncertainty together with their 8.1 absorbed dose; dose measurement; dosimeter; dosim-
methods of estimation, statistical distributions (for example, etry; dosimetry system; electron beam; gamma radiation;
rectangular, Gaussian), magnitudes and methods of combina- ionizing radiation; quality control; radiation processing;
tion. X-radiation

8 © ISO/ASTM International 2020 – All rights reserved

 ISO/ASTM 52628:2020(E)

ANNEX

A1. SUMMARY OF THE CHARACTERISTICS OF DOSIMETERS DESCRIBED IN ASTM AND ISO/ASTM RADIATION PRO-
CESSING STANDARDS

A1.1 See Table A1.1.

© ISO/ASTM International 2020 – All rights reserved 9

 TABLE A1.1 Summary of characteristics of dosimeters described in ASTM and ISO/ASTM radiation processing standards
Dosimeter Description Radiation Type Dose Range Dose Rate Instrumentation Effect of Temperature Effect of Humidity Effect of Ambient
Light

Alanine/EPR Tablets or small rods of Electron, 1 to 105 <108 Gy s-1 EPR spectrometer Irradiation temperature Should be kept No effect
see ISO/ASTM 3 to 5 mm diameter and gamma and Gy coefficient in range below 80 % RH. Con-
Practice 51607 various lengths, X-ray +0.10 to +0.25 %/°C. trol may be required
consisting primarily of Varies with composition during measurement.
α-alanine and a small and dose. Control may be May require
amount of binder. Film required during measure- preconditioning
dosimeters on a polymer ment.
substrate are also
ISO/ASTM 52628:2020(E)

available.

Calorimeter Dosimetric absorber and Electron 102 to 105 >~10 Gy s-1 Resistance meter Possible influence No effect No effect
see ISO/ASTM thermal sensor held in Gy from environmental
Practice 51631 thermal insulation. The temperature –
dimensions depend on dependent on
the energy of the design.
electron beam.

Cellulose Acetate Films, usually as 8 mm Electron, 5 x 103 3 x 10−2 to UV Irradiation Sensitive to No effect
see ISO/ASTM wide rolls. gamma and to 106 3 x 107 Gy s−1 spectrophotometer temperature humidity –
Practice 51650 X-ray Gy coefficient requires control
approximately or water tight
+0.5 % / °C packaging

Ceric-Cerous Sulfate Aqueous solution of Electron, 5 x 102 <106 Gy s−1 UV Irradiation Not applicable No effect
see ISO/ ASTM 1.5 x 10−2 mol dm−3 gamma and to 105 spectrophotometer temperature
Practice 51205 Ce(SO4)2, Ce2(SO4)3 and X-ray Gy (320 nm) or coefficient

10
0.4 mol dm−3 H2SO4. electrochemical approximately
The dosimeter is usually cell (potentiometric −0.2 % /°C.
irradiated in sealed readout). Varies with Ce3+
2-mL glass ampoules ion concentration.
of 10-mm inner diameter.

Ethanol Aerated solution of Electron, 10 to 2 x 106 <106 Gy s−1 Mercurimetric Between Not applicable No effect
Chlorobenzene ethanol, chlorobenzene gamma and Gy titration, approximately
see ISO/ASTM and water, sometimes X-ray Spectrophotometer 0.1 and 0.4 % /
Practice 51538 with a small amount of or Oscillotitrator. °C. Varies with
acetone and benzene composition.
added. The dosimeter
ampoules are typically
2 to 5 cm3 in volume
and useful dose
range depends on the
concentration of
chlorobenzene.

Fricke Solution Aerated aqueous Electron, 20 to 4 x 102 <106 Gy s−1 UV Irradiation Not applicable No effect when used
see ISO/ASTM Prac- solution of 10−3 mol gamma and Gy (upper spectrophotometer temperature in glass ampoules
tice 51026 dm−3 ferrous sulfate, and X-ray limit can be (usual wavelength coefficient +0.12 %
0.4 mol dm−3 sulfuric extended to 303 nm). /°C.
acid. Sodium chloride, 2 x 103 Gy by
10−3 mol dm−3, is using a higher
sometimes used to concentration
reduce the effect of trace of ferrous ions
organic impurities, but and by solution
not in the case of saturation with
higher dose use. oxygen).

© ISO/ASTM International 2020 – All rights reserved

 TABLE A1.1 Continued
Dosimeter Description Radiation Type Dose Range Dose Rate Instrumentation Effect of Temperature Effect of Humidity Effect of Ambient
Light

Potassium/Silver Aqueous solution of Electron, 2 x 103 Pulsed: UV Irradiation Not applicable No effect
dichromate 2 x 10−3 mol dm−3 gamma and to 5 x 104 Gy <600 spectrophotometer temperature
see ISO/ASTM potassium dichromate X-ray Gy/pulse (usual coefficient
Practice 51401 plus 5 x 10−4 mol dm−3 (12.5 pps). wavelengths: 350 approximately
silver dichromate in 0.1 Continuous: or 440 nm). −0.2 % / °C.
mol dm–3 perchloric <7.5 x 103 Varies with
acid. If 5 x 10−4 mol dm−3 Gy s−1 temperature.
silver dichromate only
is used, it can be used
for a lower dose range

© ISO/ASTM International 2020 – All rights reserved

from 2 to 10 kGy.

Polymethylmetha- PMMA strips, with or Electron, 102 to 105 10–2 to 107 Spectrophotometer Complex Sensitive to Effect
crylate (PMMA) without radiation gamma and Gy Gy s−1(may (various temperature humidity – dependent on
see ISO/ASTM sensitive dyes. X-ray need correction wavelengths dependence requires control formulation
Practice 51276 for dose rate depending on during irradiation or water tight
dependence) dosimeter type). and after packaging
irradiation

Radiochromic liquid Organic or aqueous Electron, 5 x 10-1 <10−2 to Spectrophotometer Irradiation Not applicable Sensitive
see ISO/ASTM solutions of leuco gamma and to 4 x 104 Gy 1011Gy s−1 (wavelength temperature to ambient
Practice 51540 (colorless) dyes that X-ray dependent on dye coefficient light at
become intensely and dose range) approximately wavelengths
colored upon irradiation. − 0.2 % /°C. <370 nm
Several organic dyes Varies with

11
and solvents in a wide composition.
range of concentrations
are applicable. The
solution is usually
irradiated in sealed glass
ampoules (1, 2, or 5
mL) or in appropriate
glass or plastic vials.
Open containers may be
used for low-energy
applications

Radiochromic Film Polymer films Electron, 100 to 105 <1013 Gy s−1 Spectrophotometer Complex dose Complex dose Sensitive
see ISO/ASTM containing leuco gamma and Gy (wavelength dependent dependent to ambient
Practice 51275 (colorless) dyes that X-ray dependent on dye interactions interactions light at
become intensely and dose range). between between wavelengths
colored upon irradiation. temperature and temperature and <370 nm
Film thicknesses vary water content. water content -
from a few micrometers requires control
to about 1 mm. or water tight
packaging.

Radiochromic Organic solutions of Electron, 100 to 104 10−3 to 103 Spectrophotometer Irradiation Not applicable Sensitive
Optical Waveguide leuco (colorless) dyes gamma and Gy Gy s−1 (wavelength temperature to ambient
see ISO/ASTM held in flexible plastic X-ray dependent on dye coefficient light at
Practice 51310 tubes that are sealed at and dose range). approximately wavelengths
both ends by glass or +0.3 % /°C. <370 nm
plastic beads or small rods. Varies with
composition.
ISO/ASTM 52628:2020(E)
 ISO/ASTM 52628:2020(E)

TABLE A1.1 Continued

Dosimeter Description Radiation Type Dose Range Dose Rate Instrumentation Effect of Temperature Effect of Humidity Effect of Ambient
Light

Thermoluminescence Crystalline material in Electron, 10−4 to 103 10−2 to 1010 Heat cycling TL Varies with Varies with Varies with material
dosimeters (TLD) the form of powder, gamma and Gy Gy s−1 reader material. material. May
see ISO/ASTM pellets, single crystals, X-ray Temperature require control
Practice 51956 or in sealed during and after or water tight
glass tubes or irradiation may packaging.
bulbs, or suspended in plastics. need to be
When subjected to controlled.

12
a carefully controlled
heating program, the
freed electrons and holes
from traps recombine
with the emission of
characteristic light. Most
commonly employed
materials for TLD are
LiF, CaF2, CaSO4, and Li2Bi4O7.

© ISO/ASTM International 2020 – All rights reserved

 ISO/ASTM 52628:2020(E)

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© ISO/ASTM International 2020 – All rights reserved 13