Practice for characterization and performance of a high-dose radiation dosimetry calibration laboratory

ISO/ASTM 51400:2003 addresses the specific requirements for laboratories engaged in dosimetry calibrations involving ionizing radiation, namely, gamma-radiation, electron beams or X-radiation (bremsstrahlung) beams. It specifically describes the requirements for the characterization and performance criteria to be met by a high-dose radiation dosimetry calibration laboratory.

Pratique de caractérisation et d'exploitation d'un laboratoire d'étalonnage de dosimétrie d'irradiations à hautes doses

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Status
Withdrawn
Publication Date
17-Aug-2003
Withdrawal Date
17-Aug-2003
Current Stage
9599 - Withdrawal of International Standard
Completion Date
18-Nov-2013
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INTERNATIONAL ISO/ASTM
STANDARD 51400
Second edition
2003-07-15
Practice for characterization and
performance of a high-dose radiation
dosimetry calibration laboratory
Pratique de caractérisation et d’exploitation d’un laboratoire
d’étalonnage de dosimétrie d’irradiations à hautes doses
Reference number
ISO/ASTM 51400:2003(E)
© ISO/ASTM International 2003

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ISO/ASTM 51400:2003(E)
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ii © ISO/ASTM International 2003 – All rights reserved

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ISO/ASTM 51400:2003(E)
Contents Page
1 Scope . 1
2 Referenced documents . 1
3 Terminology . 1
4 Significance and use . 2
5 Specific criteria for ionizing radiation . 2
6 Measurement uncertainty . 4
7 Keywords . 4
ANNEX . 5
© ISO/ASTM International 2003 – All rights reserved iii

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ISO/ASTM 51400:2003(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 51400 was developed by ASTM Committee E10, Nuclear Technology and
Applications, through Subcommittee E10.01, and by Technical Committee ISO/TC 85, Nuclear Energy.
Annex A1 of this International Standard is for information only.
iv © ISO/ASTM International 2003 – All rights reserved

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ISO/ASTM 51400 – 2003(E)
Standard Practice for
Characterization and Performance of a High-Dose Radiation
1
Dosimetry Calibration Laboratory
This standard is issued under the fixed designation ISO/ASTM 51400; 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 2116 Practice for Dosimetry for a Self-Contained Dry-
2
Storage Gamma-Ray Irradiator
1.1 This practice addresses the specific requirements for
2.2 ISO/ASTM Standards:
laboratories engaged in dosimetry calibrations involving ion-
51261 Guide for Selection and Calibration of Dosimetry
izing radiation, namely, gamma-radiation, electron beams or
2
Systems for Radiation Processing
X-radiation (bremsstrahlung) beams. It specifically describes
51707 Guide for Estimating Uncertainties in Dosimetry for
the requirements for the characterization and performance
2
Radiation Processing
criteria to be met by a high-dose radiation dosimetry calibra-
2.3 International Organization for Standardization Docu-
tion laboratory.
ments:
1.2 The absorbed-dose range is typically between 10 and
5
ISO/IEC 17025 (1999) General Requirements for the Com-
10 Gy.
3
petence of Calibration and Testing Laboratories
1.3 This practice addresses criteria for laboratories seeking
2.4 International Commission on Radiation Units and
accreditation for performing high-dose dosimetry calibrations,
Measurements (ICRU) Reports:
and is a supplement to the general requirements described in
ICRU Report 60, Fundamental Quantities and Units for
ISO/IEC 17025.
4
Ionizing Radiation
1.3.1 By meeting these criteria and those in ISO/IEC 17025,
the laboratory may be accredited by a recognized accreditation
3. Terminology
organization.
3.1 Definitions:
1.3.2 Adherence to these criteria will help to ensure high
3.1.1 accredited dosimetry calibration laboratory—
standards of performance and instill confidence regarding the
dosimetry laboratory that has formal recognition that it is
competency of the accredited laboratory with respect to the
competent to carry out specific calibrations in accordance with
services it offers.
documented requirements of a recognized accreditation orga-
1.4 This standard does not purport to address all of the
nization.
safety concerns, if any, associated with its use. It is the
3.1.2 calibration—process whereby the response of a do-
responsibility of the user of this standard to establish appro-
simeter or measuring instrument is characterized through
priate safety and health practices and determine the applica-
comparison with an appropriate standard that is traceable to,
bility of regulatory limitations prior to use.
and consistent with, a nationally or internationally recognized
2. Referenced documents standard.
3.1.3 dosimetry system—system used for determining ab-
2.1 ASTM Standards:
sorbed dose, consisting of dosimeters, measurement instru-
E 170 Terminology Relating to Radiation Measurements
2
ments and their associated reference standards, and procedures
and Dosimetry
for the system’s use.
E 1249 Practice for Minimizing Dosimetry Errors in Radia-
3.1.4 measurement quality assurance plan—documented
tion Hardness Testing of Silicon Electronic Devices Using
2
program for the measurement process that ensures, on a
Co-60 Sources
continuing basis, that the overall uncertainty meets the require-
E 1250 Test Method for Application of Ionization Cham-
ments of the specific application. This plan requires traceability
bers to Assess the Low Energy Gamma Component of
to, and consistency with, nationally or internationally recog-
Cobalt-60 Irradiators Used in Radiation-Hardness Testing
2 nized standards.
of Silicon Electronic Devices
3.1.5 measurement traceability—ability to demonstrate by
means of an unbroken chain of comparisons that a measure-
1
This practice is under the jurisdiction of ASTM Committee E10 on Nuclear ment is in agreement within acceptable limits of uncertainty
Technology and Applications and is the direct responsibility of Subcommittee
with comparable nationally or internationally recognized stan-
E10.01 on Dosimetry for Radiation Processing, and is also under the jurisdiction of
dards.
ISO/TC 85/WG 3.
Current edition approved May 28, 2003. Published July 15, 2003. Originally
e1
published as ASTM E 1400 – 91. ASTM E 1400 – 95a was adopted by ISO in
3
1998 with the intermediate designation ISO 15560:1998(E). The present Interna- Available from International Organization for Standardization (ISO), 1 Rue de
tional Standard ISO/ASTM 51400:2003(E) replaces ISO 15560 and is a major
Varembé, Case Postale 56, CH-1211, Geneva 20, Switzerland.
4
revision of the last previous edition ISO/ASTM 51400:2002(E).
Available from International Commission on Radiation Units and Measure-
2
Annual Book of ASTM Standards, Vol 12.02.
ments, 7910 Woodmont Ave., Suite 800, Bethesda, MD 20814, USA.
© ISO/ASTM International 2003 – All rights reserved
1

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ISO/ASTM 51400 – 2003(E)
3.1.6 primary-standard dosimeter—dosimeter of the high- 4.2.3 periodic performance evaluations, including profi-
5
est metrological quality, established and maintained as an ciency tests and on-site expert assessments.
absorbed-dose standard by a national or international standards 4.3 When a calibration laboratory applies for accreditation,
organization. the accreditation organization (see Annex A1) determines
3.1.7 proficiency testing—evaluation of the measurement whether the laboratory’s quality documentation is satisfactory,
capability of a calibration laboratory and demonstration of performs proficiency tests for each calibration category for
consistency with appropriate national standards. which accreditation is requested, and provides technical ex-
3.1.8 quality assurance—all systematic actions necessary to perts for on-site assessments to determine whether the labora-
provide adequate confidence that a calibration, measurement or
tory meets the criteria of this practice, the accreditation
process is performed to a predefined level of quality. organization and those of ISO/IEC 17025.
3.1.9 quality control—operational techniques and proce-
4.4 Section 5 sets forth specific criteria for laboratories
dures that are employed routinely to achieve and sustain a
engaged in dosimetry calibrations involving ionizing radiation,
predefined level of quality.
that is, gamma-radiation, electron beams and X-radiation
3.1.10 quality manual—document stating the quality policy, (bremsstrahlung) beams. This section amplifies and interprets
quality system, and quality practices of an organization.
the general requirements of ISO/IEC 17025.
3.1.11 quality system—documented organizational struc-
ture, responsibilities, procedures, processes, and resources for
5. Specific criteria for ionizing radiation
implementing quality management.
5.1 This section sets specific requirements to which a
3.1.12 radiation processing—intentional irradiation of
laboratory shall adhere if it is to be accredited for dosimetry
products or materials to preserve, modify, or improve their
calibrations involving ionizing radiation, specifically gamma-
characteristics.
radiation, electron beams and X-radiation (bremsstrahlung)
3.1.13 recognized accreditation organization— organiza-
beams. This section amplifies and interprets certain general
tion, operating in conformance with national regulations or
requirements set forth in ISO/IEC 17025.
requirements, that conducts and administers a laboratory ac-
5.2 This section is to be used in conjunction with ISO/IEC
creditation program and grants accreditation to calibration
17025 to assess ionizing radiation dosimetry calibration labo-
laboratories.
ratories for the purpose of accreditation by an appropriate
3.1.14 reference-standard dosimeter—dosimeter of high
accreditation organization.
metrological quality used as a standard to provide measure-
5.3 This section may also be used with ISO/IEC 17025 as a
ments traceable to, and consistent with, measurements made
guide by ionizing radiation dosimetry calibration laboratories
using primary-standard dosimeters.
in the development and implementation of their quality sys-
3.1.15 transfer-standard dosimeter—dosimeter, often a
tems.
reference-standard dosimeter suitable for transport between
5.4 Quality System, Assessment and Review:
different locations, used to compare absorbed-dose measure-
5.4.1 The quality manual and related quality documentation
ments.
shall contain:
3.2 Definitions of other terms used in this standard that
5.4.1.1 A statement of the scope of the laboratory’s work for
pertain to radiation measurement and dosimetry may be found
which accreditation is sought, including the radiation types,
in ASTM Terminology E 170. Definitions in E 170 are com-
energies, and dose rates, and
patible with ICRU 60; that document, therefore, may be used
5.4.1.2 Documentation of the model and serial numbers of
as an alternative reference.
each critical piece of equipment used in a particular calibration.
4. Significance and use
5.4.2 The laboratory’s proficiency shall be tested at a
frequency specified by the accreditation organization.
4.1 The radiation industry needs reliable, prompt dosimetry
5.4.2.1 The proficiency tests of the calibration laboratory
ca
...

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