ASTM ISO/ASTM52628-19

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: Historical
• Publication Date: 30-Sep-2018
• ICS: 17.240 - Radiation measurements
• Technical Committee: E61 - Radiation Processing
• Drafting Committee: E61.01 - Dosimetry

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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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
ISO/ASTM 52628:2019(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.
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
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, 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
1

---------------------- Page: 1 ----------------------
ISO/ASTM 52628:2019(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 measurements in accordance with
System
the ASTM E61 series of dosimetry standards. In addition, it
51276 Practice for Use of a Polymethylmethacrylate Dosim-
provides guidance on the selection of dosimetry systems and
etry System
directs the user to other standards that provide specific infor-
51310 Practice for Use of a Radiochromic Optical Wave-
mation o
...

This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
ISO/ASTM 52628:2013(E)
ISO/ASTM 52628 − 2019(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.
INTRODUCTION
The use of ionizing radiation for the treatment of commercial products such as the sterilization of
medical devices,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.
It In some applications, it is necessary to ensure that the specified absorbed dose is applied in each
of the radiation processing applications. The 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 comprisescomprise 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.
1
This practice is under the jurisdiction of ASTM Committee E61 on Radiation Processing and is the direct responsibility of Subcommittee E61.01 on Dosimetry, and is
also under the jurisdiction of ISO/TC 85/WG 3.
Current edition approved July 20, 2013. September 2019. Published November 2013December 2019. Originally published as ASTM E2628–09. Last previous ASTM
ε1 ε1
edition E2628–09E2628-09. . The present International Standard ISO/ASTM 52628–2013(E)52628–2019(E) replaces ASTM E2628–09ISO/ASTM 52628–13. .
© ISO/ASTM International 2020 – All rights reserved
1

---------------------- Page: 1 ----------------------
ISO/ASTM 52628:2019(E)
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
...