ISO/ASTM 51204:2004
(Main)Practice for dosimetry in gamma irradiation facilities for food processing
Practice for dosimetry in gamma irradiation facilities for food processing
ISO/ASTM 51204:2004 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 food 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 operational qualification, performance qualification, and routine processing that may influence absorbed dose in the product are also discussed. Information about effective or regulatory dose limits for food products is not within the scope of ISO/ASTM 51204:2004. ISO/ASTM 51204:2004 does not provide guidance in the selection and calibration of dosimetry systems, and interpretation of measured absorbed dose in the product or the use of specific dosimetry systems. ISO/ASTM 51204:2004 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 des produits alimentaires par irradiation gamma
General Information
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Standards Content (Sample)
INTERNATIONAL ISO/ASTM
STANDARD 51204
Second edition
2004-08-15
Practice for dosimetry in gamma
irradiation facilities for food processing
Pratique de la dosimétrie dans les installations de traitement des
produits alimentaires par irradiation gamma
Reference number
ISO/ASTM 51204:2004(E)
© ISO/ASTM International 2004
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ISO/ASTM 51204:2004(E)
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ISO/ASTM 51204:2004(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 . 3
8 Installation qualification . 4
9 Operational qualification . 5
10 Performance qualification . 6
11 Routine product processing . 7
12 Certification . 8
13 Measurement uncertainty . 9
14 Keywords . 9
Bibliography . 9
Figure 1 An example of the maximum and minimum absorbed-dose locations in a typical process
load . 5
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ISO/ASTM 51204:2004(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 51204 was developed by ASTM Committee E10, Nuclear Technology and
Applications, through Subcommittee E10.01, and by Technical Committee ISO/TC 85, Nuclear energy.
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ISO/ASTM 51204:2004(E)
Standard Practice for
Dosimetry in Gamma Irradiation Facilities for Food
1
Processing
This standard is issued under the fixed designation ISO/ASTM 51204; 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 E 170 Terminology Relating to Radiation Measurements
and Dosimetry
1.1 This practice outlines the installation qualification pro-
E 666 Practice for Calculating Absorbed Dose from Gamma
gram for an irradiator and the dosimetric procedures to be
or X Radiation
followed during operational qualification, performance quali-
E 1026 Practice for Using the Fricke Reference Standard
fication, and routine processing in facilities that process food
Dosimetry System
with ionizing radiation from radionuclide gamma sources to
E 2232 Guide for Selection and Use of Mathematical Mod-
ensure that product has been treated within a predetermined
els for Calculating Absorbed Dose in Radiation-Processing
range of absorbed dose. Other procedures related to operational
Applications
qualification, performance qualification, and routine process-
E 2304 Practice for Use of a LiF Photo-Fluorescent Film
ing that may influence absorbed dose in the product are also
Dosimetry System
discussed. Information about effective or regulatory dose limits
F 1355 Guide for the Irradiation of Fresh Fruits as a
for food products is not within the scope of this practice (see
Phytosanitary Treatment
ASTM Guides F 1355, F 1356, F 1736, and F 1885).
F 1356 Guide for the Irradiation of Fresh and Frozen Red
NOTE 1—Dosimetry is only one component of a total quality assurance
Meats and Poultry to Control Pathogens and Other Micro-
program for adherence to good manufacturing practices used in the
organisms
production of safe and wholesome food.
F 1736 Guide for the Irradiation of Finfish and Shellfish to
NOTE 2—ISO/ASTM Practice 51431 describes dosimetric procedures
Control Pathogens and Spoilage Microorganisms
for electron beam and X-ray (bremsstrahlung) irradiation facilities for
F 1885 Guide for Irradiation of Dried Spices, Herbs, and
food processing.
Vegetable Seasonings to Control Pathogens and Other
1.2 For guidance in the selection and calibration of dosim-
Microorganisms
etry systems, and interpretation of measured absorbed dose in
2
2.2 ISO/ASTM Standards:
the product, see ISO/ASTM Guide 51261 and ASTM Practice
51205 Practice for Use of a Ceric-Cerous Sulfate Dosimetry
E 666. For the use of specific dosimetry systems, see ASTM
System
Practices E 1026 and E 2304, and ISO/ASTM Practices 51205,
51261 Guide for Selection and Calibration of Dosimetry
51275, 51276, 51310, 51401, 51538, 51540, 51607, 51650,
Systems for Radiation Processing
and 51956. For discussion of radiation dosimetry for gamma-
51275 Practice for Use of a Radiochromic Film Dosimetry
rays and X-rays also see ICRU Report 14.
System
1.3 This standard does not purport to address all of the
51276 Practice for Use of a Polymethylmethacrylate Do-
safety concerns, if any, associated with its use. It is the
simetry System
responsibility of the user of this standard to establish appro-
51310 Practice for Use of a Radiochromic Optical
priate safety and health practices and determine the applica-
Waveguide Dosimetry System
bility of regulatory limitations prior to use.
51400 Practice for Characterization and Performance of a
2. Referenced documents High-Dose Radiation Dosimetry Calibration Laboratory
2 51401 Practice for Use of a Dichromate Dosimetry System
2.1 ASTM Standards:
51431 Practice for Dosimetry in Electron Beam and X-ray
bremsstrahlung Irradiation Facilities for Food Processing
1
This practice is under the jurisdiction of ASTM Committee E10 on Nuclear 51538 Practice for Use of an Ethanol-Chlorobenzene Do-
Technology and Applications and is the direct responsibility of Subcommittee
simetry System
E10.01 on Dosimetry for Radiation Processing and is also under the jurisdiction of
51539 Guide for the Use of Radiation-Sensitive Indicators
ISO/TC 85/WG 3.
51540 Practice for the Use of a Radiochromic Liquid
Current edition approved June 30, 2004. Published August 15, 2004. Originally
e1
published as ASTM E 1204 – 87. Last previous edition E 1204–97 . ASTM
Dosimetry System
E 1204 - 93 was adopted by ISO in 1998 with the intermediate designation ISO
51607 Practice for the Use of the Alanine-EPR Dosimetry
15554:1998(E). The present International Standard ISO/ASTM 51204:2004(E)
System
replaces ISO 15554 and is a major revision of the last previous edition ISO/ASTM
51204:2002(E). 51650 Practice for the Use of a Cellulose Acetate Dosimetry
2
For referenced ASTM and ISO/ASTM standards, visit the ASTM website,
System
www.astm.org, or contact ASTM Customer Service at service@astm.org. For
51707 Guide for Estimating Uncertainties in Dosimetry for
Annual Book of ASTM Standards volume information, refer to the standard’s
Radiation Processing
Document Summary page on the ASTM website.
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ISO/ASTM 51204:2004(E)
51956 Practice for Use of Thermoluminescence-Dosimetry 3.1.9 irradiation time—total time during which a process
(TLD) Systems for Radiation Processing load is exposed to radiation.
2.3 International Commission on Radiation Units and
3.1.10 operational qualification—obtaining and document-
3
Measurements (ICRU) Reports:
ing evidence that installed equipment and instrumentation
ICRU Report 14 Radiation Dosimetry: X-Rays and Gamma
operate within predetermined limits when used in accordance
Rays with Maximum Photon Energies Between 0.6 and 50
with operational procedures.
MeV
3.1.11 performance qualification—obtaining and docu-
ICRU Report 60 Fundamental Quantities and Units for
menting evidence that the equipment and instrumentation, as
Ionizing Radiation
installed and operated in accordance with operational proce-
dures, consistently perform according to predetermined criteria
3. Terminology
and thereby yield product that meets specifications.
3.1 Definitions:
3.1.12 primary–standard dosimeter—dosimeter of the high-
3.1.1 absorbed dose, D—quantity of ionizing radiation
est metrological quality, established and maintained as an
energy imparted per unit mass of a specified material. The SI
absorbed-dose standard by a national or international standards
unit of absorbed dose is the gray (Gy), where 1 gray is
organization (see ISO/ASTM Guide 51261).
equivalent to the absorption of 1 joule per kilogram of the
3.1.13 process load—volume of material with a specified
specified material (1 Gy = 1 J/kg). The mathematical relation-
loading configuration irradiated as a single entity.
ship is the quotient of de¯ by dm, where de¯ is the mean
3.1.14 production run (applicable to continuous-flow and
incremental energy imparted by ionizing radiation to matter of
shuffle-dwell irradiations)—a series of process loads consisting
incremental mass dm (see ICRU Report 60).
of materials or products having similar radiation-absorption
D 5 de¯/dm (1)
characteristics that are irradiated sequentially to a specified
3.1.2 absorbed-dose mapping—measurement of absorbed
range of absorbed dose.
dose within a process load using dosimeters placed at specified
3.1.15 reference-standard dosimeter—dosimeter of high
locations to produce a one-, two- or three-dimensional distri-
metrological quality, used as a standard to provide measure-
bution of absorbed dose, thus rendering a map of absorbed-
ments traceable to and consistent with measurements made
dose values.
using primary-standard dosimeters (see ISO/ASTM Guide
3.1.3 calibration facility—combination of an ionizing radia-
51261).
tion source and its associated instrumentation that provides, at
3.1.16 response function—mathematical representation of
a specified location and within a specific material, a uniform
the relationship between dosimeter response and absorbed dose
and reproducible absorbed dose, or absorbed-dose rate, trace-
for a given dosimetry system.
able to national or international standards and that may be used
3.1.17 routine dosimeter—dosimeter calibrated against a
to derive the dosimetry system’s response function or calibra-
primary-, reference-, or transfer-standard dosimeter and used
tion curve.
for routine absorbed-dose measurements (see ISO/ASTM
3.1.4 compensating dummy—simulated product used during
Guide 51261).
routine production runs in process loads that contain less
3.1.18 simulated product—material with attenuation and
product than specified in the product loading configuration, or
scattering properties similar to those of the product, material,
simulated product used at the beginning or end of a production
or substance to be irradiated.
run, to compensate for the absence of product. Also see 3.1.18.
3.1.18.1 Discussion—Simulated product is used during op-
3.1.4.1 Discussion—Simulated product or phantom material
erational qualification as a substitution for the actual product,
may be used during operational qualification as a substitute for
material, or substance to be irradiated. When used in routine
the actual product, material, or substance to be irradiated.
production runs, it is sometimes referred to as “compensating
3.1.5 dosimeter response—reproducible, quantifiable radia-
dummy.” When used for absorbed-dose mapping, simulated
tion effect produced in the dosimeter by a given absorbed dose.
product is sometimes referred to as “phantom material.”
3.1.6 dosimeter set—one or more dosimeters used to mea-
3.1.19 transfer-standard dosimeter—dosimeter, often a
sure the absorbed dose at a location and whose average reading
reference-standard dosimeter, suitable for transport between
is used as the absorbed-dose measurement at that location.
different locations, used to compare absorbed-dose measure-
3.1.7 dosimetry system—system used for determining ab-
ments (see ISO/ASTM Guide 51261).
sorbed dose consisting of dosimeters, measurement instru-
3.2 Definitions of other terms used in this standard that
ments and their associated reference standards, and procedures
pertain to radiation measurement and dosimetry may be found
for the system’s use.
in ASTM Terminology E 170. Definitions in E 170 are com-
3.1.8 installation qualification—obtaining and documenting
patible with ICRU 60; ICRU 60, therefore, may be used as an
evidence that the irradiator, with all its associated equipment
alternative reference.
and instrumentation, has been provided and installed in accor-
dance with specifications.
4. Significance and use
3
4.1 Food products may be treated with ionizing radiation,
Available from the International Commission on Radiation Units and Measure-
60 137
ments, 7910 Woodmont Ave., Suite 800, Bethesda, MD 20814, USA. such as gamma-rays from Co or Cs sources, for numerous
© ISO/ASTM International 2004 – All rights reserved
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ISO/ASTM 51204:2004(E)
purposes, including control of parasites and pathogenic micro- 5.4 Between source replenishments, removals, or redistribu-
organisms, insect disinfestation, growth and maturation inhi- tions, the sole variation in the source output is the steady
bition, and shelf-life extension. Food irradiation specifications reduction in the activity caused by the radioactive decay.
almost always include a minimum or maximum limit of
6. Types of facilities
absorbed dose, sometimes both: a minimum limit is set to
6.1 The design of an irradiator affects the delivery of
ensure that the intended beneficial effect is achieved and a
absorbed dose to a product. Therefore, the irradiator design
maximum limit is set for the purpose of avoiding product or
should be considered when performing the absorbed-dose
packaging degradation. For a given application, one or both of
measurements described in Sections 8-11.
these values may be prescribed by government regulations that
6.2 Food processing facilities may be categorized by oper-
have been established on the basis of scientific data. Therefore,
ating mode (for example, batch or continuous), conveyor
prior to the irradiation of the food product, it is necessary to
system (for example, continuous or shuffle-dwell), and irradia-
determine the capability of an irradiation facility to deliver the
tor type (for example, container or bulk flow).
absorbed dose within any prescribed limits. Also, it is neces-
6.2.1 Food products may be moved to the location in the
sary to monitor and document the absorbed dose during each
facility where the irradiation will take place, either while the
production run to verify compliance with the process specifi-
source is fully shielded (batch operation) or while the source is
cations at a predetermined level of confidence.
exposed (continuous operation).
NOTE 3—The Codex Alimentarius Commission has developed an
6.2.2 Food products may be transported past the source at a
international General Standard and a Code of Practice that address the
uniform and controlled speed (continuous conveyance), or may
application of ionizing radiation to the treatment of foods and that strongly
instead undergo a series of discrete controlled movements
emphasize the role of dosimetry for ensuring that irradiation will be
4
properly performed (1). separated by controlled time periods during which the process
load is stationary (shuffle-dwell).
4.2 Some food products are processed in the chilled or
6.2.3 For most commercial irradiators, the process load
frozen state. Therefore, dosimeters used for routine processing
generally makes one or more passes on each side of the source
should be selected for their functionality under those condi-
array.
tions. Moreover, the temperature of a dosimeter during irradia-
6.2.3.1 Process loads may move past a source array in a
tion should be sufficiently stable to allow correction for
configuration in which the source either extends above and
temperature effects on the dosimeter response. To avoid the
below the process load (source overlap) or the process load
influence of temperature gradients on dosimeter response and
extends above and below the source (product overlap). In the
the subsequent need to correct for these effects, methods that
latter configuration, the process load is usually moved past the
isolate the dosimeter from temperature gradients may be
source at two or more levels.
employed.
6.2.3.2 In bulk-flow irradiators, products such as grain or
NOTE 4—For more detailed discussions of radiation processing of
flour flow in loose form past the source.
various foods, see ASTM Guides F 1355, F 1356, F 1736, and F 1885 and
6.3 Because of mechanical speed limitations, various tech-
Refs (1-11).
niques may be used to reduce the absorbed-dose rates for low
4.3 To ensure that products are irradiated within a specified
absorbed-dose applications. These techniques include using
absorbed-dose range, routine process control requires routine
only a portion of the source (for example, raising only one of
product dosimetry, documented product handling procedures
several source racks to the irradiation position), using attenu-
(before, during, and after irradiation), consistent orientation of
ators, and irradiating at greater distances from the source.
the products during irradiation, monitoring of critical process
7. Dosimetry systems
parameters, and documentation of all relevant activities and
functions.
7.1 Description of Dosimeter Classes—Dosimeters may be
divided into four basic classes according to their relative
5. Radiation source characteristics
quality and areas of application: primary-standard, reference-
5.1 The radiation source used in a facility considered in this standard, transfer-standard, and routine dosimeters. ISO/
60 137
practice consists of sealed elements of Co or Cs which are ASTM Guide 51261 provides information about the selection
typically linear rods or “pencils” arranged in one or more of dosimetry systems for different applications. All classes of
planar or cylindrical arrays. dosimeters, except the primary standards, require calibration
5.2 A cobalt-60 source emits photons with energies of before their use.
approximately 1.17 and 1.33 MeV in nearly equal proportions. 7.1.1 Primary-Standard Dosimeters—Primary-standard do-
A cesium-137 source emits photons with energies of approxi- simeters are established and maintained by national standards
mately 0.662 MeV (12). laboratories for calibration of radiation environments (fields)
60 137
5.3 The half-lives for Co and Cs are approximately and other classes of dosimeters. The two most commonly used
primary-standard dosimeters are ionization chambers and calo-
5.2708 years and 30.07 years, respectively (13, 14).
rimeters.
7.1.2 Reference-Standard Dosimeters—Reference-standard
4
dosimeters are used to calibrate radiation environments and
The boldface numbers in parentheses refer to the bibliography at the end of this
practice. routine dosimeters. Reference-standard dosimeters may also be
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ISO/ASTM 51204:2004(E)
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
calibrated periodically. The calibrations shall be traceable to a
given in ISO/ASTM Guide 51261.
national or international standards laboratory.
7.1.3 Transfer-Standard Dosimeters—Transfer-standard do-
7.3.3.2 A performance check shall be made following any
simeters are specially selected dosimeters used for transferring
modification or servicing of the instruments and prior to their
absorbed-dose information from an accredited or national
use for a dosimetry system calibration. This check can be
standards laboratory to an irradiation facility in order to
accomplished by using standards, such as calibrated optical
establish traceability for that facility. These dosimeters should
density filters, wavelength standards, and thickness gauges,
be carefully used under conditions that are specified by the
supplied by the equipment manufacturer or by national or
issuing laboratory. Transfer-standard dosimeters may be se-
accredited standards laboratories.
lected from either reference-standard dosimeters or routine
7.3.3.3 See ISO/ASTM Guide 51261, the corresponding
dosimeters, taking into consideration the criteria listed in
ISO/ASTM or ASTM standard for the dosimetry system, and
ISO/ASTM Guide 51261.
instrument-specific operating manuals for instrument calibra-
7.1.4 Routine Dosimeters—Routine dosimeters may be
tion and performance verification procedures.
used for radiation process quality control, absorbed-dose moni-
toring, and absorbed-dose mapping. Proper dosimetric tech-
8. Installation qualification
niques, including calibration, shall be employed to ensure that
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
program is to demonstrate that the irradiator and its associated
given in ISO/ASTM Guide 51261. processing equipment and measurement instruments have been
delivered and installed in accordance with their specifications.
7.2 Selection of Dosimetry Systems—Select dosimetry sys-
Installation qualification includes documentation of the irradia-
tems suitable for the expected radiation processing applications
tor and the associated processing equipment and measurement
at the facility using the selection criteria listed in ISO/ASTM
instruments, establishment of the testing, operation, and cali-
Guide 51261. During the selection process, for each dosimetry
bration procedures for their use, and verification that they
system, take into consideration its performance behavior with
operate according to specifications. An effective installation
respect to relevant influence quantities and the uncertainty
qualification program will ensure consistent and correct opera-
associated with it.
tion of the irradiator so as to deliver the required absorbed dose
7.3 Calibration of Dosimetry Systems—Prior to use, a
to a product.
dosimetry system shall be calibrated in accordance with the
8.2 Equipment Documentation—Document descriptions of
user’s documented procedure that specifies details of the
the irradiator and the associated processing equipment and
calibration process and quality assurance requirements. This
measurement instruments installed at the facility. This docu-
calibration process shall be repeated at regular intervals to
mentation shall be retained for the life of the facility. At a
ensure that the accuracy of the absorbed-dose measurement is
minimum, it shall include:
maintained within required limits. Calibration methods are
8.2.1 Description of the location of the irradiator within the
described in ISO/ASTM Guide 51261. Irradiation is a critical
operator’s premises in relation to the areas assigned and the
component of the calibration of a dosimetry system.
means established for ensuring the segregation of un-irradiated
7.3.1 Calibration Irradiation of Reference- or Transfer-
products from irradiated products;
Standard Dosimeters—Calibration irradiations shall be per-
8.2.2 Description of the operating procedure of the irradia-
formed at an accredited calibration laboratory or in-house
tor;
calibration facility meeting the requirements of ISO/ASTM
8.2.3 Description of the construction and operation of the
Practice 51400. The laboratory or facility shall provide an
product handling equipment;
absorbed dose (or absorbed-dose rate) having measurement
8.2.4 Description of the materials and construction of any
traceability to nationally or internationally recognized stan-
dards. containers used to hold food products during irradiation;
8.2.5 Description of the process control system;
7.3.2 Calibration Irradiation of Routine Dosimeters—
8.2.6 Description of any modifications made during and
Calibration irradiations may be performed per 7.3.1 or at a
production or research irradiation facility together with after the irradiator installation.
reference- or transfer-standard dosimeters that have measure-
8.3 Testing, Operation and Calibration Procedures—
ment traceability to nationally or internationally recognized
Establish and implement standard operating procedures for the
standards. This statement also applies when reference-standard
testing, operation and calibration (if necessary) of the installed
dosimeters are used as routine dosimeters.
irradiator and its associated processing equipment and mea-
surement instruments.
7.3.3 Measurement Instrument Calibration and Perfor-
mance Verification—Establish and implement procedures for 8.3.1 Testing Procedures—These procedures describe the
calibrating the measurement instruments and for checking their testing methods used to ensure that the installed irradiator and
performance periodically to ensure that the instruments are its associated processing equipment and measurement instru-
functioning according to performance specifications. ments operate according to specification.
© ISO/ASTM International 2004 – All rights reserved
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