ISO/ASTM 51702:2004
(Main)Practice for dosimetry in a gamma irradiation facility for radiation processing
Practice for dosimetry in a gamma irradiation facility for radiation processing
ISO/ASTM 51702:2004 outlines the installation qualification program for an irradiator and the dosimetric procedures to be followed during operational qualification, performance qualification, and routine processing in facilities that process product with ionizing radiation from radionuclide gamma sources to ensure that product has been treated within a predetermined range of absorbed dose. Other procedures related to installation qualification, operational qualification, performance qualification, and routine processing that may influence absorbed dose in the product are also discussed. Information about effective or regulatory absorbed-dose limits is not within the scope of ISO/ASTM 51702:2004. ISO/ASTM 51702:2004 does not provide guidance in the selection and calibration of dosimetry systems, thte interpretation of measured absorbed dose in the product or the use of specific dosimetry systems. ISO/ASTM 51702:2004 does not purport to address all of the safety concerns, if any, associated with its use.
Pratique de la dosimétrie dans les installations de traitement par irradiation gamma
General Information
Relations
Standards Content (Sample)
INTERNATIONAL ISO/ASTM
STANDARD 51702
Second edition
2004-08-15
Practice for dosimetry in gamma
irradiation facilities for radiation
processing
Pratique de la dosimétrie dans les installations de traitement par
irradiation gamma
Reference number
ISO/ASTM 51702:2004(E)
© ISO/ASTM International 2004
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ISO/ASTM 51702:2004(E)
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ISO/ASTM 51702:2004(E)
Contents Page
1 Scope . 1
2 Referenced documents . 1
3 Terminology . 2
4 Significance and use . 3
5 Radiation source characteristics . 3
6 Types of facilities . 3
7 Dosimetry systems . 4
8 Installation qualification . 4
9 Operational qualification . 5
10 Performance qualification . 6
11 Routine product processing . 8
12 Certification . 9
13 Measurement uncertainty . 9
14 Keywords . 9
Bibliography . 10
Figure 1 An example of the maximum and minimum absorbed-dose locations in a typical process
load . 6
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ISO/ASTM 51702:2004(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
Draft International Standards adopted by the technical committees are circulated to the member bodies for
voting. Publication as an International Standard requires approval by at least 75% of the member bodies
casting a vote.
ASTM International is one of the world’s largest voluntary standards development organizations with global
participation from affected stakeholders. ASTM technical committees follow rigorous due process balloting
procedures.
A project between ISO and ASTM International has been formed to develop and maintain a group of
ISO/ASTM radiation processing dosimetry standards. Under this project, ASTM Subcommittee E10.01,
Dosimetry for Radiation Processing, is responsible for the development and maintenance of these dosimetry
standards with unrestricted participation and input from appropriate ISO member bodies.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. Neither ISO nor ASTM International shall be held responsible for identifying any or all such patent
rights.
International Standard ISO/ASTM 51702 was developed by ASTM Committee E10, Nuclear Technology and
Applications, through Subcommittee E10.01, and by Technical Committee ISO/TC 85, Nuclear energy.
iv © ISO/ASTM International 2004 – All rights reserved
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ISO/ASTM 51702:2004(E)
Standard Practice for
Dosimetry in Gamma Irradiation Facilities for Radiation
1
Processing
This standard is issued under the fixed designation ISO/ASTM 51702; the number immediately following the designation indicates the
year of original adoption or, in the case of revision, the year of last revision.
1. Scope 2. Referenced documents
2
1.1 This practice outlines the installation qualification pro- 2.1 ASTM Standards:
gram for an irradiator and the dosimetric procedures to be E 170 Terminology Relating to Radiation Measurements
followed during operational qualification, performance quali- and Dosimetry
fication, and routine processing in facilities that process prod- E 666 Practice for Calculating Absorbed Dose from Gamma
uct with ionizing radiation from radionuclide gamma sources or X Radiation
to ensure that product has been treated within a predetermined E 1026 Practice for Using the Fricke Reference Standard
range of absorbed dose. Other procedures related to installation Dosimetry System
qualification, operational qualification, performance qualifica- E 2232 Guide for Selection and Use of Mathematical Mod-
tion, and routine processing that may influence absorbed dose els for Calculating Absorbed Dose in Radiation-Processing
in the product are also discussed. Information about effective Applications
or regulatory absorbed-dose limits is not within the scope of E 2304 Practice for Use of a LiF Photo-Fluorescent Film
this practice. Dosimetry System
2
2.2 ISO/ASTM Standards:
NOTE 1—Dosimetry is only one component of a total quality assurance
51204 Practice for Dosimetry in Gamma Irradiation Facili-
program for adherence to good manufacturing practices.
ties for Food Processing
NOTE 2—ISO/ASTM Practices 51649 and 51608 describe dosimetric
51205 Practice for Use of a Ceric-Cerous Sulfate Dosimetry
procedures for electron beam and X-ray (bremsstrahlung) irradiation
facilities for radiation processing.
System
51261 Guide for Selection and Calibration of Dosimetry
1.2 For the irradiation of food and the radiation sterilization
Systems for Radiation Processing
of health care products, other specific ISO/ASTM or ISO
51275 Practice for Use of a Radiochromic Film Dosimetry
standards exist. For food irradiation, see ISO/ASTM Practice
System
51204. For the radiation sterilization of health care products,
51276 Practice for Use of a Polymethylmethacrylate Do-
see ISO 11137. In those areas covered by ISO/ASTM Practice
simetry System
51204 or ISO 11137, those standards take precedence.
51310 Practice for Use of a Radiochromic Optical
1.3 For guidance in the selection and calibration of dosim-
Waveguide Dosimetry System
etry systems, and interpretation of measured absorbed dose in
51400 Practice for Characterization and Performance of a
the product, see ISO/ASTM Guide 51261 and ASTM Practice
High-Dose Radiation Dosimetry Calibration Laboratory
E 666. For the use of specific dosimetry systems, see ASTM
51401 Practice for Use of a Dichromate Dosimetry System
Practices E 1026 and E 2304, and ISO/ASTM Practices 51205,
51538 Practice for Use of the Ethanol-Chlorobenzene Do-
51275, 51276, 51310, 51401, 51538, 51540, 51607, 51650,
simetry System
and 51956. For discussion of radiation dosimetry for gamma-
51539 Guide for Use of Radiation-Sensitive Indicators
rays and X-rays also see ICRU Report 14.
51540 Practice for Use of a Radiochromic Liquid Dosim-
1.4 This standard does not purport to address all of the
etry System
safety concerns, if any, associated with its use. It is the
51607 Practice for Use of the Alanine-EPR Dosimetry
responsibility of the user of this standard to establish appro-
System
priate safety and health practices and determine the applica-
51608 Practice for Dosimetry in an X-Ray (Bremsstrahl-
bility of regulatory limitations prior to use.
ung) Facility for Radiation Processing
51649 Practice for Dosimetry at Energies Between 300 KeV
and 25 KeV
1
This practice is under the jurisdiction of ASTM Committee E10 on Nuclear
51650 Practice for Use of a Cellulose Acetate Dosimetry
Technology and Applications and is the direct responsibility of Subcommittee
System
E10.01 on Dosimetry for Radiation Processing, and is also under the jurisdiction of
ISO/TC 85/WG 3.
Current edition approved June 30, 2004. Published August 15, 2004. Originally
published as E 1702-95. Last previous ASTM edition E 1702–00. ASTM
2
e1
For referenced ASTM and ISO/ASTM standards, visit the ASTM website,
E 1702–95 was adopted by ISO in 1998 with the intermediate designation ISO
www.astm.org, or contact ASTM Customer Service at service@astm.org. For
15571:1998(E). The present International Standard ISO/ASTM 51702:2004(E)
Annual Book of ASTM Standards volume information, refer to the standard’s
replaces ISO 15571 and is a major revision of the last previous edition ISO/ASTM
51702–2002(E). Document Summary page on the ASTM website.
© ISO/ASTM International 2004 – All rights reserved
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ISO/ASTM 51702:2004(E)
51707 Guide for Estimating Uncertainties in Dosimetry for 3.1.7 dosimetry system—system used for determining ab-
Radiation Processing sorbed dose, consisting of dosimeters, measurement instru-
51956 Practice for Use of Thermoluminescence-Dosimetry ments and their associated reference standards, and procedures
(TLD) Systems for Radiation Processing for the system’s use.
2.3 International Commission on Radiation Units and 3.1.8 installation qualification—obtaining and documenting
Measurements (ICRU) Reports:
evidence that the irradiator, with all its associated equipment
ICRU Report 14 Radiation Dosimetry: X-Rays and Gamma and instrumentation, has been provided and installed in accor-
Rays with Maximum Photon Energies Between 0.6 and 50
dance with specifications.
3
MeV
3.1.9 irradiation time—total time during which a process
ICRU Report 60 Fundamental Quantities and Units for
load is exposed to radiation.
3
Ionizing Radiation
3.1.10 operational qualification—obtaining and document-
2.4 ISO Standard:
ing evidence that installed equipment and instrumentation
ISO 11137 Sterilization of Health Care Products–Require-
operate within predetermined limits when used in accordance
ments for Validation and Routine Control-Radiation Ster-
with operational procedures.
4
ilization
3.1.11 performance qualification—obtaining and docu-
menting evidence that the equipment and instrumentation, as
3. Terminology
installed and operated in accordance with operational proce-
3.1 Definitions:
dures, consistently perform according to predetermined criteria
3.1.1 absorbed dose, D—quantity of ionizing radiation
and thereby yield product that meets specifications.
energy imparted per unit mass of a specified material. The SI
3.1.12 primary-standard dosimeter—dosimeter of the high-
unit of absorbed dose is the gray (Gy), where 1 gray is
est metrological quality, established and maintained as an
equivalent to the absorption of 1 joule per kilogram of the
absorbed-dose standard by a national or international standards
specified material (1 Gy = 1 J/kg). The mathematical relation-
organization (see ISO/ASTM Guide 51261).
ship is the quotient of de¯ by dm, where de¯ is the mean
3.1.13 process load—volume of material with a specified
incremental energy imparted by ionizing radiation to matter of
loading configuration irradiated as a single entity.
incremental mass dm (see ICRU Report 60).
3.1.14 production run (applicable to continuous-flow and
D 5 de¯/dm (1)
shuffle-dwell irradiations)—a series of process loads consisting
of materials or products having similar radiation-absorption
3.1.2 absorbed-dose mapping—measurement of absorbed
characteristics that are irradiated sequentially to a specified
dose within a process load using dosimeters placed at specified
range of absorbed dose.
locations to produce a one-, two- or three-dimensional distri-
3.1.15 reference-standard dosimeter—dosimeter of high
bution of absorbed dose, thus rendering a map of absorbed-
metrological quality, used as a standard to provide measure-
dose values.
ments traceable to and consistent with measurements made
3.1.3 calibration facility—combination of an ionizing radia-
using primary-standard dosimeters (see ISO/ASTM Guide
tion source and its associated instrumentation that provides, at
51261).
a specified location and within a specific material, a uniform
3.1.16 response function—mathematical representation of
and reproducible absorbed dose, or absorbed-dose rate, trace-
able to national or international standards and that may be used the relationship between dosimeter response and absorbed dose
for a given dosimetry system.
to derive the dosimetry system’s response function or calibra-
tion curve. 3.1.17 routine dosimeter—dosimeter calibrated against a
3.1.4 compensating dummy—simulated product used during primary-, reference-, or transfer-standard dosimeter and used
routine production runs in process loads that contain less for routine absorbed-dose measurements (see ISO/ASTM
product than specified in the product loading configuration, or Guide 51261).
simulated product used at the beginning or end of a production
3.1.18 simulated product—mass of material with attenua-
run, to compensate for the absence of product. Also see 3.1.18. tion and scattering properties similar to those of the product,
3.1.4.1 Discussion—Simulated product or phantom material
material, or substance to be irradiated.
may be used during operational qualification as a substitute for
3.1.18.1 Discussion—Simulated product is used during op-
the actual product, material, or substance to be irradiated.
erational qualification as a substitution for the actual product,
3.1.5 dosimeter response—reproducible, quantifiable radia-
material, or substance to be irradiated. When used in routine
tion effect produced by a given absorbed dose.
production runs, it is sometimes referred to as “compensating
3.1.6 dosimeter set—one or more dosimeters used to mea-
dummy.” When used for absorbed-dose mapping, simulated
sure the absorbed dose at a location and whose average reading
product is sometimes referred to as “phantom material.”
is used as the absorbed-dose measurement at that location.
3.1.19 transfer-standard dosimeter—dosimeter, often a
reference-standard dosimeter, suitable for transport between
different locations, used to compare absorbed-dose measure-
3
Available from the International Commission on Radiation Units and Measure-
ments (see ISO/ASTM Guide 51261).
ments, 7910 Woodmont Ave., Suite 800, Bethesda, MD 20814, USA.
4
3.2 Definitions of other terms used in this standard that
Available from International Organization for Standardization (ISO), 1 rue de
Varembé, Case postale 56, CH-1211, Geneva 20, Switzerland. pertain to radiation measurement and dosimetry may be found
© ISO/ASTM International 2004 – All rights reserved
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ISO/ASTM 51702:2004(E)
in ASTM Terminology E 170. Definitions in E 170 are com- dosimetry. For these applications, it may be necessary to
patible with ICRU 60; ICRU 60, therefore, may be used as an perform dosimetry at ambient room temperatures and rely on
alternative reference. process control to ensure that the absorbed dose is within the
desired limits. In some cases it may be possible to use
4. Significance and use
dosimeters for routine monitoring at the temperature used for
4.1 Various products and materials may be treated with
the irradiation application if the dosimeter temperature during
60 137
ionizing radiation, such as gamma rays from Co or Cs
irradiation is sufficiently stable to allow correction for tempera-
sources, for numerous purposes, including microbial reduction
ture effects on the dosimeter response.
and material modification. Dosimetry requirements may vary
5. Radiation source characteristics
depending upon the irradiation application and the end use of
the product.
5.1 The radiation source used in a facility considered in this
60 137
4.2 For many products, the irradiation specifications include
practice consists of sealed elements of Co or Cs which are
a minimum or maximum limit of absorbed dose, sometimes
typically linear rods or “pencils” arranged in one or more
both: a minimum is set to ensure that the intended beneficial
planar or cylindrical arrays.
effect is achieved and a maximum limit is set for the purpose
5.2 Cobalt-60 emits photons with energies of approximately
of avoiding product degradation.
1.17 and 1.33 MeV in nearly equal proportions. Cesium-137
5
4.2.1 For a given application, one or both of these values
emits photons with energies of approximately 0.662 MeV (1).
60 137
may be prescribed by regulations that have been established on
5.3 The half-lives for Co and Cs are approximately
the basis of available scientific data. Therefore, it is necessary
5.2708 years and 30.07 years, respectively (2, 3).
to determine the capability of an irradiation facility to deliver
5.4 Between source replenishments, removals, or redistribu-
the absorbed dose within prescribed limits prior to the irradia-
tions, the sole variation in the source output is the steady
tion of the product. Also, it is necessary to monitor and
reduction in the activity caused by the radioactive decay.
document the absorbed dose during each production run to
verify compliance with the process specifications within a 6. Types of facilities
predetermined level of confidence.
6.1 The design of an irradiator affects the delivery of
4.2.2 Some examples of irradiation applications where do-
absorbed dose to a product. Therefore, the irradiator design
simetry requirements are similar to those required for food
should be considered when performing the absorbed-dose
irradiation or for radiation sterilization of health care products
measurements described in Sections 8-11.
are:
6.2 Radiation processing facilities may be categorized by
4.2.2.1 Disinfection of consumer product;
operating mode (for example, batch or continuous), conveyor
4.2.2.2 Control of pathogens in liquids or solids; and
system (for example, continuous or shuffle-dwell), and irradia-
4.2.2.3 Research on material effects.
tor type (for example, container or bulk flow).
4.3 For other products, the irradiation specifications may
6.2.1 Product may be moved to the location in the facility
depend on the evaluation of changes in the physical and
where the irradiation will take place, either while the source is
chemical properties of the irradiated materials.
fully shielded (batch operation) or while the source is exposed
4.3.1 For these products, the requirements for dosimetry
(continuous operation).
may be less stringent, but dosimetry data may be useful for
6.2.2 Product may be transported past the source at a
quality control, transfer of the process to another facility or for
uniform and controlled speed (continuous conveyance), or may
comparison with data from other facilities.
instead undergo a series of discrete controlled movements
4.3.2 Some examples of radiation applications where all of
separated by controlled time periods during which the process
the dosimetry requirements stated in this practice may not be
load is stationary (shuffle-dwell).
required are:
6.2.3 For most commercial irradiators, the process load
4.3.2.1 Cross-linking or degradation of polymers and elas-
generally makes one or more passes on each side of the source
tomers;
array.
4.3.2.2 Polymerization of monomers and grafting of mono-
6.2.3.1 Process loads may move past a source array in a
mers onto polymers; and
configuration in which the source either extends above and
4.3.2.3 Enhancement of color in gemstones and other ma-
below the process load (source overlap) or the process load
terials.
extends above and below the source (product overlap). In the
4.4 For some products, the requirements for dosimetry may
latter configuration, the process load is usually moved past the
be different.
source at two or more levels.
4.4.1 An example of a radiation application with different
6.2.3.2 In bulk-flow irradiators, product flows in loose form
requirements is:
past the source.
4.4.1.1 The requirement to determine the absorbed dose in
6.3 Because of mechanical speed limitations, various tech-
silicon or other materials different from water in radiation
niques may be used to reduce the absorbed-dose rates for low
hardness testing of semiconductors or the modification of
characteristics of semiconductor devices.
5
4.5 For some radiation applications, the irradiations may be
The boldface numbers in parentheses refer to the bibliography at the end of this
practice.
performed at low or high temperatures, causing difficulties in
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ISO/ASTM 51702:2004(E)
absorbed-dose applications. These techniques include using bration methods are described in ISO/ASTM Guide 51261.
only a portion of the source (for example, raising only one of Irradiation is a critical component of the calibration of a
several source racks to the irradiation position), using attenu- dosimetry system.
ators, and irradiating at greater distances from the source.
7.3.1 Calibration Irradiation of Reference- or Transfer-
Standard Dosimeters—Calibration irradiations shall be per-
7. Dosimetry systems
formed at an accredited calibration laboratory or in-house
7.1 Description of Dosimeter Classes—Dosimeters may be
calibration facility meeting the requirements of ISO/ASTM
divided into four basic classes according to their relative
Practice 51400. The laboratory or facility shall provide an
quality and areas of application: primary-standard, reference-
absorbed dose (or absorbed-dose rate) having measurement
standard, transfer-standard, and routine dosimeters. ISO/
traceability to nationally or internationally recognized stan-
ASTM Guide 51261 provides information about the selection
dards.
of dosimetry systems for different applications. All classes of
7.3.2 Calibration Irradiation of Routine Dosimeters—
dosimeters, except the primary standards, require calibration
Calibration irradiations may be performed per 7.3.1 or at a
before their use.
production or research irradiation facility together with
7.1.1 Primary-Standard Dosimeters—Primary-standard do-
reference- or transfer-standard dosimeters that have measure-
simeters are established and maintained by national standards
ment traceability to nationally or internationally recognized
laboratories for calibration of radiation environments (fields)
standards. This statement also applies when reference-standard
and other classes of dosimeters. The two most commonly used
dosimeters are used as routine dosimeters.
primary-standard dosimeters are ionization chambers and calo-
7.3.3 Measurement Instrument Calibration and Perfor-
rimeters.
mance Verification—Establish and implement procedures for
7.1.2 Reference-Standard Dosimeters—Reference-standard
calibrating the measurement instruments and for checking their
dosimeters are used to calibrate radiation environments and
performance periodically to ensure that the instruments are
routine dosimeters. Reference-standard dosimeters may also be
functioning according to performance specifications.
used as routine dosimeters. Examples of reference-standard
7.3.3.1 Document a calibration program to ensure that all
dosimeters, along with their useful absorbed-dose ranges, are
measurement instruments used in the analysis of dosimeters are
given in ISO/ASTM Guide 51261.
calibrated periodically. The calibrations shall be traceable to a
7.1.3 Transfer-Standard Dosimeters—Transfer-standard do-
national or international standards laboratory.
simeters are specially selected dosimeters used for transferring
7.3.3.2 A performance check shall be made following any
absorbed-dose information from an accredited or national
modification or servicing of the instruments and prior to their
standards laboratory to an irradiation facility in order to
use for a dosimetry system calibration. This check can be
establish traceability for that facility. These dosimeters should
accomplished by using standards, such as calibrated optical
be carefully used under conditions that are specified by the
density filters, wavelength standards, and calibrated thickness
issuing laboratory. Transfer-standard dosimeters may be se-
gauges, supplied by the equipment manufacturer or by national
lected from either reference-standard dosimeters or routine
or accredited standards laboratories.
dosimeters, taking into consideration the criteria listed in
7.3.3.3 See ISO/ASTM Guide 51261, the corresponding
ISO/ASTM Guide 51261.
ISO/ASTM or ASTM standard for the dosimetry system, and
7.1.4 Routine Dosimeters—Routine dosimeters may be
instrument-specific operating manuals for instrument calibra-
used for radiation process quality control, absorbed-dose moni-
tion and performance verification procedures.
toring, and absorbed-dose mapping. Proper dosimetric tech-
niques, including calibration, shall be employed to ensure that
8. Installation qualification
measurements are reliable and accurate. Examples of routine
8.1 Objective—The purpose of an installation qualification
dosimeters, along with their useful absorbed-dose ranges, are
given in ISO/ASTM Guide 51261. program is to demonstrate that the irradiator with its associated
processing equipment and measurement instruments have been
7.2 Selection of Dosimetry Systems—Select dosimetry sys-
tems suitable for the expected radiation processing applications delivered and installed in accordance with their specifications.
Installation qualification includes documentation of the irradia-
at the facility using the selection criteria listed in ISO/ASTM
tor and the associated processing equipment and measurement
Guide 51261. During the selection process, for each dosimetry
instruments, establishment of the testing, operation and cali-
system, take into consideration its performance behavior with
bration procedures for their use, and verification that they
respect to relevant influence quantities and the uncertainty
operate according to specifications. An effective installation
associated with it.
qualification program will ensure consistent and correct opera-
7.3 Calibration of Dosimetry Systems—Prior to use, a
tion of the irradiator so as to deliver the required absorbed dose
dosimetry system (consisting of a specific batch of dosimeters
to a product.
and specific measurement instruments) shall be calibrated in
accordance with the user’s documented procedure that speci- 8.2 Equipment Documentation—Establish and document
fies details of the calibration process and quality assurance descriptions of the irradiator and the associated processing
requirements. This calibration process shall be repeated at equipment and measurement instruments installed at the facil-
regular intervals to ensure that the accuracy of the absorbed- ity. This documentation shall be retained for the life of the
facility. At a minimum, it shall include:
dose measurement is maintained within required limits. Cali-
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ISO/ASTM 51702:2004(E)
8.2.1 Description of the location of the irradiator within the any portion of product in a process
...
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