ASTM E2628-09
(Practice)Standard Practice for Dosimetry for Radiation Processing
Standard Practice for Dosimetry for Radiation Processing
SIGNIFICANCE AND USE
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.
To demonstrate control of the radiation process, 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 E10.01 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 and health practices and determine the applicability of regulatory limitations prior to use.
General Information
Relations
Standards Content (Sample)
NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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.
An American National Standard
Designation: E2628 – 09
Standard Practice for
Dosimetry for Radiation Processing
This standard is issued under the fixed designation E2628; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
INTRODUCTION
The use of ionizing radiation for the treatment of commercial products such as the sterilization of
medical devices, 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.
It is necessary to ensure that the specified absorbed dose is applied in each of the radiation
processing applications. 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
validationoftheradiationprocessingapplications.Inparticular,ICRUReport80providesinformation
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 has under its jurisdiction
approximately 30 standard practices and standard guides, collectively known as the E10.01 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.Acurrent list of the E10.01 standards
on radiation processing is given in 2.1 and 2.2.
The development, validation and routine control of a radiation process comprises 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 is known, including the effect of influence quantities. The E10.01 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. Practice E2628 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 Practice E2628 for the general requirements.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
E2628 – 09
1. Scope F1736 Guide for Irradiation of Finfish andAquatic Inverte-
brates Used as Food to Control Pathogens and Spoilage
1.1 Thispracticedescribesthebasicrequirementsthatapply
Microorganisms
when making absorbed dose measurements in accordance with
F1885 Guide for Irradiation of Dried Spices, Herbs, and
theASTM E10.01 series of dosimetry standards. In addition, it
Vegetable Seasonings to Control Pathogens and Other
provides guidance on the selection of dosimetry systems and
Microorganisms
directs the user to other standards that provide specific infor-
2.2 ISO/ASTM Standards:
mation on individual dosimetry systems, calibration methods,
51204 Practice for Dosimetry in Gamma Irradiation Facili-
uncertainty estimation and radiation processing applications.
ties for Food Processing
1.2 This practice applies to dosimetry for radiation process-
ing applications using electrons or photons (gamma- or 51205 PracticeforUseofaCeric-CerousSulfateDosimetry
X-radiation).
System
1.3 This practice addresses the minimum requirements of a
51261 Guide for Selection and Calibration of Dosimetry
measurement management system,butdoesnotincludegeneral
Systems for Radiation Processing
quality system requirements.
51275 Practice for the Use of a Radiochromic Film Dosim-
1.4 This practice does not address personnel dosimetry or
etry System
medical dosimetry.
51276 Practice for the Use of a Polymethylmethacrylate
1.5 This practice does not apply to primary standard dosim-
Dosimetry System
etry systems.
51310 Practice for the Use of a Radiochromic Optical
1.6 This standard does not purport to address all of the
Waveguide Dosimetry System
safety concerns, if any, associated with its use. It is the
51401 Practice for Use of a Dichromatic Dosimetry System
responsibility of the user of this standard to establish appro-
priate safety and health practices and determine the applica-
51431 Practice for Dosimetry in Electron Beam and X-Ray
bility of regulatory limitations prior to use. (Bremsstrahlung) Irradiation Facilities for Food Process-
ing
2. Referenced Documents
51538 Practice for Use of the Ethanol-Chlorobenzene Do-
2.1 ASTM Standards:
simetry System
E170 TerminologyRelatingtoRadiationMeasurementsand
51540 Practice for Use of a Radiochromic Liquid Dosim-
Dosimetry
etry System
E1026 Practice for Using the Fricke Reference-Standard
51607 Practice for Use of the Alanine-EPR Dosimetry
Dosimetry System
System
E2232 Guide for Selection and Use of Mathematical Meth-
51608 Practice for Dosimetry in an X-Ray (Bremmstrahl-
odsforCalculatingAbsorbedDoseinRadiationProcessing
ung) Facility for Radiation Processing
Applications
E2303 Guide for Absorbed-Dose Mapping in Radiation 51631 Practice for Use of Calorimetric Dosimetry Systems
Processing Facilities for Electron Beam Dose Measurements and Routine
E2304 Practice for Use of a LiF Photo-Fluorescent Film Dosimeter Calibration
Dosimetry System
51649 Practice for Dosimetry in an Electron-Beam Facility
E2381 Guide for Dosimetry In Radiation Processing of
for Radiation Processing at Energies Between 300 keV
Fluidized Beds and Fluid Streams
and 25 MeV
E2449 Guide for Irradiation of Pre-packaged Processed
51650 Practice for Use of Cellulose Triacetate Dosimetry
Meat and Poultry Products to Control Pathogens and Other
Systems
Microorganisms
51702 Practice for Dosimetry in a Gamma Irradiation Fa-
E2701 Guide for Performance Characterization of Dosim-
cility for Radiation Processing
etersandDosimetrySystemsforUseinRadiationProcess-
51707 Guide for Estimating Uncertainties in Dosimetry for
ing
Radiation Processing
F1355 Guide for Irradiation of Fresh Agricultural Produce
51818 Practice for Dosimetry in an Electron Beam Facility
as a Phytosanitary Treatment
for Radiation Processing at Energies Between 80 and 300
F1356 Practice for Irradiation of Fresh and Frozen Red
keV
Meat and Poultry to Control Pathogens and Other Micro-
51900 Guide for Dosimetry in Radiation Research on Food
organisms
and Agricultural Products
1 51939 Practice for Blood Irradiation Dosimetry
This practice is under the jurisdiction of ASTM Committee E10 on Nuclear
Technology and Applications and is the direct responsibility of Subcommittee
51940 Guide for Dosimetry for Sterile Insect Release Pro-
E10.01 on Radiation Processing: Dosimetry and Applications.
grams
Current edition approved Aug. 15, 2009. Published September 2009. DOI:
10.1520/E2628-09. 51956 Practice for Thermoluminescence-Dosimetry (TLD)
For referenced ASTM and ISO/ASTM standards, visit the ASTM website,
Systems for Radiation Processing
www.astm.org, or contact ASTM Customer Service at service@astm.org. For
52116 Practice for Dosimetry for a Self-Contained Dry-
Annual Book of ASTM Standards volume information, refer to the standard’s
Document Summary page on the ASTM website. Storage Gamma-Ray Irradiator
E2628 – 09
2.3 ISO Standards: 3.1.6 dosimeter response—reproducible,quantifiableradia-
ISO 11137-1 Sterilization of health care products – Radia- tion effect produced in the dosimeter.
tion – Part 1: Requirements for development, validation
3.1.7 dosimetry—measurement of absorbed dose by the use
and routine control of a sterilization process for medical
of a dosimetry system.
devices
3.1.8 dosimetry system—system used for measuring ab-
ISO 11137-3 Sterilization of health care products – Radia-
sorbed dose, consisting of dosimeters, measurement instru-
tion – Part 3: Guidance on dosimetric aspects
ments and their associated reference standards, and procedures
ISO 10012 Measurement managements systems – Require-
for the system’s use.
ments for measurement processes and measuring equip-
3.1.9 influence quantity—quantity that is not the measurand
ment
but that affects the result of the measurement.
ISO 17025 General requirements for the competence of
3.1.10 measurement management system—set of interre-
testing and calibration laboratories
2.4 International Commission on Radiation Units and lated or interacting elements necessary to achieve metrological
Measurements (ICRU) Reports: confirmation and continual control of measurement processes.
ICRU Report 60 Fundamental Quantities and Units for
3.1.11 primary standard dosimetry system —dosimetry sys-
Ionizing Radiation
tem that is designated or widely acknowledged as having the
ICRU Report 80 Dosimetry Systems for Use in Radiation
highest metrological qualities and whose value is accepted
Processing
without reference to other standards of the same quantity.
2.5 ISO Reports:
3.1.12 radiation processing—intentional irradiation of
GUM Guide to the Expression of Uncertainty in Measure-
products or materials to preserve, modify or improve their
ment, 1995
characteristics.
VIM International Vocabulary of Basic and General Terms
3.1.13 reference standard dosimetry system—dosimetry
in Metrology, 1993
system, generally having the highest metrological quality
available at a given location or in a given organization, from
3. Terminology
which measurements made there are derived.
3.1 Definitions:
3.1.14 reference standard radiation field—calibrated radia-
3.1.1 absorbed dose—quantity of ionizing radiation energy
tion field, generally having the highest metrological quality
imparted per unit mass of a specified material. The SI unit of
available at a given location or in a given organization, from
absorbed dose is the gray (Gy), where 1 gray is equivalent to
which measurements made there are derived.
the absorption of 1 joule per kilogram of the specified material
(1 Gy = 1 J/kg). The mathematical relationship is the quotient 3.1.15 response function—mathematical representation of
– –
therelationshipbetweendosimeterresponseandabsorbeddose
of d´by dm,where d´isthemeanincrementalenergyimparted
for a given dosimetry system.
by ionizing radiation to matter of incremental mass dm.
3.1.16 routine dosimetry system—dosimetry system cali-
3.1.2 accredited dosimetry calibration laboratory—
brated against a reference standard dosimetry system and used
dosimetry laboratory with formal recognition by an accrediting
for routine absorbed dose measurements, including dose map-
organization that the dosimetry laboratory is competent to
carry out specific activities which lead to the calibration or ping and process monitoring.
calibration verification of dosimetry systems in accordance
3.1.17 traceability—propertyoftheresultofameasurement
with documented requirements of the accrediting organization.
or the value of a standard whereby it can be related to stated
3.1.3 calibration—set of operations that establish, under
references, usually national or international standards, through
specified conditions, the relationship between values of quan-
an unbroken chain of comparisons all having stated uncertain-
tities indicated by a measuring instrument or measuring sys-
ties.
tem,orvaluesrepresentedbyamaterialmeasureorareference
3.1.18 transfer standard dosimetry system—dosimetry sys-
material, and the corresponding values realized by standards.
tem used as an intermediary to calibrate other dosimetry
3.1.4 dosimeter—device that, when irradiated, exhibits a
systems.
quantifiable change that can be related to absorbed dose in a
3.1.19 type I dosimeter—dosimeter of high metrological
given material using appropriate measurement instruments and
quality, the response of which is affected by individual influ-
procedures.
ence quantities in a well-defined way that can be expressed in
3.1.5 dosimeter/dosimetry system characterization
terms of independent correction factors.
—determination of performance characteristics, such as dose
3.1.19.1 Discussion—See Section 6 for examples and fur-
range, reproducibility and the effect of influence quantities, for
ther details.
a dosimeter/dosimetry system under defined test conditions.
3.1.20 type II dosimeter—dosimeter, the response of which
isaffectedbyinfluencequantitiesinacomplexwaythatcannot
practically be expressed in terms of independent correction
Available from International Organization for Standardization (ISO), 1, ch. de
la Voie-Creuse, Case postale 56, CH-1211, Geneva 20, Switzerland, http://
factors.
www.iso.ch.
4 3.1.20.1 Discussion—See Section 6 for examples and fur-
Available from the International Commission on Radiation Units and Measure-
ments, 7910 Woodmont Ave, Suite 800, Bethesda, MD 20815, USA. ther details.
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.