ASTM ISO/ASTM51707-15
(Guide)Standard Guide for Estimation of Measurement Uncertainty in Dosimetry for Radiation Processing
Standard Guide for Estimation of Measurement Uncertainty in Dosimetry for Radiation Processing
SIGNIFICANCE AND USE
4.1 All measurements, including dose measurements, have an associated uncertainty. The magnitude of the measurement uncertainty is important for assessing the quality of the results of the measurement system.
4.2 Information on the range of achievable uncertainty values for specific dosimetry systems is given in the ISO/ASTM standards for the specific dosimetry systems. While the uncertainty values given in specific dosimetry standards are achievable, it should be noted that both smaller and larger uncertainty values might be obtained depending on measurement conditions and instrumentation. For more information see also ISO/ASTM 52628.
4.3 This guide uses the methodology adopted by the GUM for estimating uncertainties in measurements (see 2.4). Therefore, components of uncertainty are evaluated as either Type A uncertainty or Type B uncertainty.
4.4 Quantifying individual components of uncertainty may assist the user in identifying actions to reduce the measurement uncertainty.
4.5 Periodically, the uncertainty should be reassessed to confirm the existing estimate. Should changes occur that could influence the existing component estimates or result in the addition of new components of uncertainty, a new estimate of uncertainty should be established.
4.6 Although this guide provides a framework for assessing uncertainty, it cannot substitute for critical thinking, intellectual honesty, and professional skill. The evaluation of uncertainty is neither a routine task nor a purely mathematical one; it depends on detailed knowledge of the nature of the measurand and of the measurement method and procedure used. The quality and utility of the uncertainty quoted for the result of a measurement therefore ultimately depends on the understanding, critical analysis, and integrity of those who contribute to the assignment of its value (JCGM 100:2008).
SCOPE
1.1 This standard provides guidance on the use of concepts described in the JCGM Evaluation of Measurement Data – Guide to the Expression of Uncertainty in Measurement (GUM) to estimate the uncertainties in the measurement of absorbed dose in radiation processing.
1.2 Methods are given for identifying, evaluating and estimating the components of measurement uncertainty associated with the use of dosimetry systems and for calculating combined standard measurement uncertainty and expanded (overall) uncertainty of dose measurements based on the GUM methodology.
1.3 Examples are given on how to develop a measurement uncertainty budget and a statement of uncertainty.
1.4 This document is one of a set of standards that provides recommendations for properly implementing dosimetry in radiation processing, and provides guidance for achieving compliance with the requirements of ISO/ASTM 52628 related to the evaluation and documentation of the uncertainties associated with measurements made with a dosimetry system. It is intended to be read in conjunction with ISO/ASTM 52628, ISO/ASTM 51261 and ISO/ASTM 52701.
1.5 This guide does not address the establishment of process specifications or conformity assessment.
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.
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This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
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ISO/ASTM 51707:2015(E)
Standard Guide for
Estimation of Measurement Uncertainty in Dosimetry for
1
Radiation Processing
This standard is issued under the fixed designation ISO/ASTM 51707; 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 priate safety and health practices and determine the applica-
bility of regulatory limitations prior to use.
1.1 This standard provides guidance on the use of concepts
described in the JCGM Evaluation of Measurement Data –
2. Referenced documents
Guide to the Expression of Uncertainty in Measurement
2
(GUM) to estimate the uncertainties in the measurement of
2.1 ASTM Standards:
absorbed dose in radiation processing.
E170 Terminology Relating to Radiation Measurements and
1.2 Methods are given for identifying, evaluating and esti- Dosimetry
mating the components of measurement uncertainty associated E456 Terminology Relating to Quality and Statistics
with the use of dosimetry systems and for calculating com- 2
2.2 ISO/ASTM Standards:
bined standard measurement uncertainty and expanded (over-
51261 Practice for Calibration of Routine Dosimetry Sys-
all) uncertainty of dose measurements based on the GUM
tems for Radiation Processing
methodology.
51608 Practice for Dosimetry in an X-Ray (Bremsstrahlung)
1.3 Examples are given on how to develop a measurement
Facility for Radiation Processing
uncertainty budget and a statement of uncertainty.
51649 Practice for Dosimetry in an Electron Beam Facility
for Radiation Processing at Energies Between 300 keV
1.4 This document is one of a set of standards that provides
and 25 MeV
recommendations for properly implementing dosimetry in
51702 Practice for Dosimetry in a Gamma Facility for
radiation processing, and provides guidance for achieving
Radiation Processing
compliancewiththerequirementsofISO/ASTM52628related
52628 Practice for Dosimetry in Radiation Processing
to the evaluation and documentation of the uncertainties
52701 Guide for Performance Characterization of Dosim-
associated with measurements made with a dosimetry system.
eters and Dosimetry systems for Use in Radiation Pro-
ItisintendedtobereadinconjunctionwithISO/ASTM52628,
cessing
ISO/ASTM 51261 and ISO/ASTM 52701.
2.3 ISO Documents:
1.5 Thisguidedoesnotaddresstheestablishmentofprocess
ISO 11137-1 Sterilization of Health Care Products – Radia-
specifications or conformity assessment.
tion – Requirements for Development, Validation and
1.6 This standard does not purport to address all of the
3
Routine Control of a Sterilization Process
safety concerns, if any, associated with its use. It is the
ISO/IEC 17025 General Requirements for the Competence
responsibility of the user of this standard to establish appro-
4
of Testing and Calibration Laboratories
1
This guide is under the jurisdiction of ASTM Committee E61 on Radiation
2
Processing and is the direct responsibility of Subcommittee E61.01 on Dosimetry, For referenced ASTM and ISO/ASTM standards, visit the ASTM website,
and is also under the jurisdiction of ISO/TC 85/WG 3. www.astm.org, or contact ASTM Customer Service at service@astm.org. For
Current edition approved Sept. 8, 2014. Published February 2015. Originally Annual Book of ASTM Standards volume information, refer to the standard’s
ε1
published as ASTM E 1707–95. Last previous ASTM edition E 1707–95 . ASTM Document Summary page on the ASTM website.
ε1 3
E 1707–95 was adopted by ISO in 1998 with the intermediate designation ISO Available from Association for the Advancement of Medical Instrumentation,
15572:1998(E). The present International Standard ISO/ASTM 51707:2015(E) is a 1110 North Glebe Road, Suite 220, Arlington, VA 22201-4795, U.S.A.
4
major revision of the last previous edition ISO/ASTM 51707:2005(E), which Available from International Organization for Standardization (ISO), 1, ch. de
replaced ISO/ASTM 51707:2002(E). la Voie-Creuse, CP 56, CH-1211 Geneva 20, Switzerland, http://www.iso.org.
© ISO/ASTM International 2018 – All rights reserved
1
---------------------- Page: 1 ----------------------
ISO/ASTM 51707:2015(E)
2.4 Joint Committee for Guides in Metrology (JCGM) 3.2.4 coeffıcient of variation (CV)—sample standard devia-
Reports: tion expressed as a percentage of sample average value (see
3.2.2 and 3.2.19):
JCGM 100:2008, GUM 1995, with minor correc-
tions, Evaluation of measurement data – Guide to the
S
5
CV 5 3100 % (2)
Expression of Uncertainty in Measurement
x¯
JCGM 200:2008, VIM, International vocabulary of metrol-
6
3.2.5 combined standard measurement uncertainty [VIM,
ogy – Basis and general concepts and associated terms
2
...
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 51707:2005(E)
ISO/ASTM 51707 − 2015(E)
An American National Standard
Standard Guide for
Estimating Uncertainties Estimation of Measurement
1
Uncertainty in Dosimetry for Radiation Processing
This standard is issued under the fixed designation ISO/ASTM 51707; 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
1.1 This standard provides guidance on the use of concepts described in the JCGM Evaluation of Measurement Data – Guide
to the Expression of Uncertainty in Measurement (GUM) to estimate the uncertainties in the measurement of absorbed dose in
radiation processing.
1.2 This guide defines possible sources of uncertainty in dosimetry performed in gamma, X-ray (bremsstrahlung), and electron
irradiation facilities and offers procedures for estimating the resulting magnitude of the uncertainties in the measurement of
absorbed dose using a dosimetry system. Basic concepts of measurement, estimate of the measured value of a quantity, “true
value”, error, and uncertainty are defined and discussed. Components of uncertainty are discussed and methods are given for
Methods are given for identifying, evaluating and estimating their values. How these contribute to the standard uncertainty in the
reported values of absorbed dose are considered and methods are given for calculating the combined standard uncertainty and an
estimate of expanded (overall) uncertainty. The methodology for evaluating components of uncertainty follows ISO procedures
(seethe components of measurement uncertainty associated with the use 2.3). The traditional concepts of precision and bias are not
used in this document. Examples are given in five annexes.of dosimetry systems and for calculating combined standard
measurement uncertainty and expanded (overall) uncertainty of dose measurements based on the GUM methodology.
1.3 Examples are given on how to develop a measurement uncertainty budget and a statement of uncertainty.
1.4 This document is one of a set of standards that provides recommendations for properly implementing dosimetry in radiation
processing, and provides guidance for achieving compliance with the requirements of ISO/ASTM 52628 related to the evaluation
and documentation of the uncertainties associated with measurements made with a dosimetry system. It is intended to be read in
conjunction with ISO/ASTM 52628, ISO/ASTM 51261 and ISO/ASTM 52701.
1.5 This guide assumes a working knowledge of statistics. Several statistical texts are included in the referencesdoes not address
the establishment (of1-4). process specifications or conformity assessment.
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.
2. Referenced documents
2
2.1 ASTM Standards:
E170 Terminology Relating to Radiation Measurements and Dosimetry
E177 Practice for Use of the Terms Precision and Bias in ASTM Test Methods
E178 Practice for Dealing With Outlying Observations
E456 Terminology Relating to Quality and Statistics
4
E876 Practice for Use of Statistics in the Evaluation of Spectrometric Data (Withdrawn 2003)
1
This guide 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 by ASTM June 1, 2004. Sept. 8, 2014. Published May 15, 2005. February 2015. Originally published as ASTM E 1707–95. Last previous ASTM
ε1 ε1
edition E 1707–95 . ASTM E 1707–95 was adopted by ISO in 1998 with the intermediate designation ISO 15572:1998(E). The present International Standard ISO/ASTM
51707:2005(E)51707:2015(E) is a major revision of the last previous edition ISO/ASTM 51707:2002(E),51707:2005(E), which replaced ISO 15572.ISO/ASTM
51707:2002(E).
2
The boldface numbers in parentheses refer to the bibliography at the end of this guide.
2
For referenced ASTM and ISO/ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at service@astm.org. For Annual Book
of ASTM Standards volume information, refer to the standard’s Document Summary page on the ASTM website.
© ISO/ASTM International 2015 – All rights reserved
1
---------------------- Page: 1 ----------------------
ISO/ASTM 51707:2015(E)
E1249 Practice for Minim
...
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 51707:2015(E)
Standard Guide for
Estimation of Measurement Uncertainty in Dosimetry for
1
Radiation Processing
This standard is issued under the fixed designation ISO/ASTM 51707; 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 responsibility of the user of this standard to establish appro-
priate safety and health practices and determine the applica-
1.1 This standard provides guidance on the use of concepts
bility of regulatory limitations prior to use.
described in the JCGM Evaluation of Measurement Data –
Guide to the Expression of Uncertainty in Measurement
2. Referenced documents
(GUM) to estimate the uncertainties in the measurement of
2
2.1 ASTM Standards:
absorbed dose in radiation processing.
E170 Terminology Relating to Radiation Measurements and
1.2 Methods are given for identifying, evaluating and esti-
Dosimetry
mating the components of measurement uncertainty associated
E456 Terminology Relating to Quality and Statistics
2
with the use of dosimetry systems and for calculating com-
2.2 ISO/ASTM Standards:
bined standard measurement uncertainty and expanded (over-
51261 Practice for Calibration of Routine Dosimetry Sys-
all) uncertainty of dose measurements based on the GUM
tems for Radiation Processing
methodology.
51608 Practice for Dosimetry in an X-Ray (Bremsstrahlung)
Facility for Radiation Processing
1.3 Examples are given on how to develop a measurement
51649 Practice for Dosimetry in an Electron Beam Facility
uncertainty budget and a statement of uncertainty.
for Radiation Processing at Energies Between 300 keV
1.4 This document is one of a set of standards that provides
and 25 MeV
recommendations for properly implementing dosimetry in
51702 Practice for Dosimetry in a Gamma Facility for
radiation processing, and provides guidance for achieving
Radiation Processing
compliance with the requirements of ISO/ASTM 52628 related
52628 Practice for Dosimetry in Radiation Processing
to the evaluation and documentation of the uncertainties
52701 Guide for Performance Characterization of Dosim-
associated with measurements made with a dosimetry system.
eters and Dosimetry systems for Use in Radiation Pro-
It is intended to be read in conjunction with ISO/ASTM 52628,
cessing
ISO/ASTM 51261 and ISO/ASTM 52701.
2.3 ISO Documents:
1.5 This guide does not address the establishment of process
ISO 11137-1 Sterilization of Health Care Products – Radia-
specifications or conformity assessment.
tion – Requirements for Development, Validation and
3
Routine Control of a Sterilization Process
1.6 This standard does not purport to address all of the
ISO/IEC 17025 General Requirements for the Competence
safety concerns, if any, associated with its use. It is the
4
of Testing and Calibration Laboratories
1
This guide is under the jurisdiction of ASTM Committee E61 on Radiation
2
Processing and is the direct responsibility of Subcommittee E61.01 on Dosimetry, For referenced ASTM and ISO/ASTM standards, visit the ASTM website,
and is also under the jurisdiction of ISO/TC 85/WG 3. www.astm.org, or contact ASTM Customer Service at service@astm.org. For
Current edition approved Sept. 8, 2014. Published February 2015. Originally Annual Book of ASTM Standards volume information, refer to the standard’s
ε1
published as ASTM E 1707–95. Last previous ASTM edition E 1707–95 . ASTM Document Summary page on the ASTM website.
ε1 3
E 1707–95 was adopted by ISO in 1998 with the intermediate designation ISO Available from Association for the Advancement of Medical Instrumentation,
15572:1998(E). The present International Standard ISO/ASTM 51707:2015(E) is a 1110 North Glebe Road, Suite 220, Arlington, VA 22201-4795, U.S.A.
4
major revision of the last previous edition ISO/ASTM 51707:2005(E), which Available from International Organization for Standardization (ISO), 1, ch. de
replaced ISO/ASTM 51707:2002(E). la Voie-Creuse, CP 56, CH-1211 Geneva 20, Switzerland, http://www.iso.org.
© ISO/ASTM International 2024 – All rights reserved
1
---------------------- Page: 1 ----------------------
ISO/ASTM 51707:2015(E)
2.4 Joint Committee for Guides in Metrology (JCGM) 3.2.4 coeffıcient of variation (CV)—sample standard devia-
Reports:
tion expressed as a percentage of sample average value (see
JCGM 100:2008, GUM 1995, with minor correc- 3.2.2 and 3.2.19):
tions, Evaluation of measurement data – Guide to the
S
5
CV 5 3 100 % (2)
Expression of Uncertainty in Measurement
x¯
JCGM 200:2008, VIM, International vocabulary of metrol-
6
3.2.5 combined standard measurement uncertainty [VIM,
ogy – Basis and general concepts and associated terms
2.31]—standard measurement uncertainty that is obtained us-
7
2.5 ICRU Reports:
ing the individual standard measurement uncertaint
...
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