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

Status
Historical
Publication Date
14-Aug-2009
Technical Committee
Drafting Committee
Current Stage
Ref Project

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ASTM E2628-09 - Standard Practice for Dosimetry for Radiation Processing
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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information.
An American National Standard
Designation: E2628 – 09
Standard Practice for
1
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.
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E2628 – 09
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