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Iso Astm 51707 - 2015
Iso Astm 51707 - 2015
1. Scope 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 2.1 ASTM Standards:2
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 ISO/ASTM Standards:2
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
1.4 This document is one of a set of standards that provides for Radiation Processing at Energies Between 300 keV
recommendations for properly implementing dosimetry in and 25 MeV
radiation processing, and provides guidance for achieving 51702 Practice for Dosimetry in a Gamma Facility for
compliance with the requirements of ISO/ASTM 52628 related Radiation Processing
to the evaluation and documentation of the uncertainties 52628 Practice for Dosimetry in Radiation Processing
associated with measurements made with a dosimetry system. 52701 Guide for Performance Characterization of Dosim-
It is intended to be read in conjunction with ISO/ASTM 52628, eters and Dosimetry systems for Use in Radiation Pro-
ISO/ASTM 51261 and ISO/ASTM 52701. cessing
1.5 This guide does not address the establishment of process 2.3 ISO Documents:
specifications or conformity assessment. ISO 11137-1 Sterilization of Health Care Products – Radia-
1.6 This standard does not purport to address all of the tion – Requirements for Development, Validation and
safety concerns, if any, associated with its use. It is the Routine Control of a Sterilization Process3
responsibility of the user of this standard to establish appro- ISO/IEC 17025 General Requirements for the Competence
of Testing and Calibration Laboratories4
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 [email protected]. For
Current edition approved by ASTM Sept. 8, 2014. Published February 2015. Annual Book of ASTM Standards volume information, refer to the standard’s
Originally published as ASTM E 1707–95. Last previous ASTM edition Document Summary page on the ASTM website.
E 1707–95ε1. ASTM E 1707–95ε1 was adopted by ISO in 1998 with the intermediate 3
Available from Association for the Advancement of Medical Instrumentation,
designation ISO 15572:1998(E). The present International Standard ISO/ASTM 1110 North Glebe Road, Suite 220, Arlington, VA 22201-4795, U.S.A.
4
51707:2015(E) is a major revision of the last previous edition ISO/ASTM Available from International Organization for Standardization (ISO), 1, ch. de
51707:2005(E), which replaced ISO/ASTM 51707:2002(E). la Voie-Creuse, CP 56, CH-1211 Geneva 20, Switzerland, http://www.iso.org.
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
Expression of Uncertainty in Measurement5 CV 5
x̄
3 100 % (2)
JCGM 200:2008, VIM, International vocabulary of metrol-
ogy – Basis and general concepts and associated terms6 3.2.5 combined standard measurement uncertainty [VIM,
7 2.31]—standard measurement uncertainty that is obtained us-
2.5 ICRU Reports:
ing the individual standard measurement uncertainties associ-
ICRU Report 80 Dosimetry Systems for Use in Radiation
Processing ated with the input quantities in a measurement model.
ICRU Report 85a Fundamental Quantities and Units for 3.2.5.1 Discussion—
Ionizing Radiation (1) It is also referred to as ‘combined standard uncertainty’.
(2) In case of correlations of input quantities in a measure-
3. Terminology ment model, covariances must also be taken into account when
calculating the combined standard measurement uncertainty.
3.1 Definitions:
3.2.6 coverage factor (k) [VIM, 2.38]—number larger than
NOTE 1—For definitions quoted here from VIM, only the text of the one by which a combined standard measurement uncertainty is
definition is kept here. Any NOTES or EXAMPLES are not included.
They can be reviewed by referring to VIM (JCGM 200:2008). multiplied to obtain an expanded measurement uncertainty.
3.2 Definitions: 3.2.6.1 Discussion—A coverage factor, k, is typically in the
range of 2 to 3 (see 5.2.4).
3.2.1 approved laboratory—laboratory that is a recognized
national metrology institute; or has been formally accredited to 3.2.7 expanded uncertainty [GUM, 2.3.5]—quantity defin-
ISO/IEC 17025; or has a quality system consistent with the ing the interval about the result of a measurement that may be
requirements of ISO/IEC 17025. expected to encompass a large fraction of the distribution of
3.2.1.1 Discussion—A recognized national metrology insti- values that could reasonably be attributed to the measurand.
tute or other calibration laboratory accredited to ISO/IEC 3.2.7.1 Discussion—Expanded uncertainty is obtained by
17025 should be used for irradiation of dosimeters or dose multiplying the combined standard uncertainty by a coverage
measurements for calibration in order to ensure traceability to factor, the value of which determines the magnitude of the
a national or international standard. A calibration certificate ‘fraction’. Expanded uncertainty is also referred to as ‘overall
provided by a laboratory not having formal recognition or uncertainty’.
accreditation will not necessarily be proof of traceability to a
3.2.8 influence quantity [VIM, 2.52]—quantity that, in a
national or international standard.
direct measurement, does not affect the quantity that is actually
3.2.2 arithmetic mean, average [GUM, C.2.19]—sum of measured, but affects the relation between the indication and
values divided by the number of values: the measurement result.
1 3.2.8.1 Discussion—In radiation processing dosimetry, this
x̄ 5
n ( x , i 5 1, 2, 3 … n
i
i (1)
term includes temperature, relative humidity, time intervals,
where: light, radiation energy, absorbed dose rate, and other factors
xi = individual values of parameters with i = 1, 2, 3 ... n. that might affect dosimeter response, as well as quantities
associated with the measurement instrument.
3.2.2.1 Discussion—The term ‘mean’ is used generally 3.2.9 level of confidence—probability that the value of a
when referring to a population parameter and the term ‘aver-
parameter will fall within the given range.
age’ when referring to the result of a calculation on the data
obtained in a sample. 3.2.10 measurand [VIM, 2.3]—quantity intended to be mea-
sured.
3.2.3 calibration curve [VIM, 4.31]—expression of the
relation between indication and corresponding measured quan- 3.2.10.1 Discussion—In radiation processing dosimetry, the
tity value. measurand is the absorbed dose (Gy) or simply ‘dose’.
3.2.3.1 Discussion—In radiation processing standards, the 3.2.11 measurement [VIM, 2.1]—process of experimentally
term “dosimeter response” is generally used for “indication”. obtaining one or more quantity values that can reasonably be
attributed to a quantity.
3.2.12 measurement uncertainty [VIM, 2.26]—non-negative
5
Document produced by Working Group 1 of the Joint Committee for Guides in parameter characterizing the dispersion of the quantity values
Metrology (JCGM/WG 1). Available free of charge at the BIPM website (http://
www.bipm.org).
being attributed to a measurand, based on the information used.
6
Document produced by Working Group 2 of the Joint Committee for Guides in 3.2.12.1 Discussion—
Metrology (JCGM/WG 2). Available free of charge at the BIPM website (http:// (1) Measurement uncertainty includes components arising
www.bipm.org).
7
Available from International Commission on Radiation Units and from systematic effects, such as components associated with
Measurements, 7910 Woodmont Ave., Suite 800 Bethesda, MD 20814, U.S.A. corrections and the assigned quantity values of measurement
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ISO/ASTM 51707:2015(E)
standards, as well as the definitional uncertainty. Sometimes (2) Repeatability conditions include: the same measure-
estimated systematic effects are not corrected for but, instead, ment procedure, the same observer, the same measuring
associated measurement uncertainty components are incorpo- instrument used under the same conditions, the same location,
rated. repetition over a short period of time.
(2) The parameter may be, for example, a standard devia- (3) Repeatability may be expressed quantitatively in terms
tion called standard measurement uncertainty (or a specified of the dispersion characteristics of the results.
multiple of it), or the half-width of an interval, having a stated
3.2.18 reproducibility (of results of measurements) [GUM,
coverage probability.
(3) Measurement uncertainty comprises, in general, many B.2.16]—closeness of the agreement between the results of
components. Some of these may be evaluated by Type A measurements of the same measurand carried out under
evaluation of measurement uncertainty from the statistical changed conditions of measurement.
distribution of the quantity values from series of measurements 3.2.18.1 Discussion—
and can be characterized by standard deviations. The other (1) A valid statement of reproducibility requires specifica-
components, which may be evaluated by Type B evaluation of tion of the conditions changed.
measurement uncertainty, can also be characterized by stan- (2) The changed conditions may include: principle of
dard deviations, evaluated from probability density functions measurements, method of measurement, observer, measuring
based on experience or other information. instrument, reference standard, location, conditions of use and
(4) In general, for a given set of information, it is under- time.
stood that the measurement uncertainty is associated with a (3) Reproducibility may be expressed quantitatively in
stated quantity value attributed to the measurand. A modifica- terms of the dispersion characteristics of the results.
tion of this value results in a modification of the associated
3.2.19 sample standard deviation (S) [adapted from GUM,
uncertainty.
C.2.21]—measure of dispersion of values of the same mea-
3.2.13 metrological traceability [VIM, 2.41]—property of a surand expressed as the positive square root of the sample
measurement result whereby the result can be related to a variance.
reference through a documented unbroken chain of
calibrations, each contributing to the measurement uncertainty. 3.2.20 sample variance [GUM, C.2.20]—measure of
3.2.13.1 Discussion— dispersion, which is the sum of the squared deviations of
(1) The unbroken chain of calibrations is referred to as observations from their average divided by (n –1), given by the
“traceability chain”. expression:
(2) Metrological traceability of a measurement result does
not ensure that the measurement uncertainty is adequate for a S2 5 ( ~ x 2 x̄ !
i
2
(3)
~n 2 1!
given purpose or that there is an absence of mistakes.
(3) The abbreviated term “traceability” is sometimes used where:
to mean ‘metrological traceability’ as well as other concepts, xi = individual value of parameter with i = 1, 2 ... n, and
such as ‘sample traceability’, ‘document traceability’, ‘instru- x̄ = mean of n values of parameter (see 3.2.2).
ment traceability’ or ‘material traceability’, where the history 3.2.21 standard measurement uncertainty [VIM, 2.30]—
(“trace”) of an item is meant. Therefore, the full term of measurement uncertainty expressed as a standard deviation.
“metrological traceability” is preferred if there is any risk of
3.2.21.1 Discussion—Also referred to as ‘standard uncer-
confusion.
tainty of measurement’ or ‘standard uncertainty’.
3.2.14 quadrature—method used in estimating combined
3.2.22 true value [VIM, 2.11]—quantity value consistent
standard uncertainty from independent sources by taking the
positive square root of the sum of the squares of individual with the definition of a quantity.
components of uncertainty, for example, coefficient of varia- 3.2.22.1 Discussion—True value is by its nature indetermi-
tion. nate and only an idealized concept. In this guide the terms “true
3.2.15 quantity [VIM, 1.1]—property of a phenomenon, value of a measurand” and “value of a measurand” are viewed
body, or substance, where the property has a magnitude that as equivalent (see 5.1.1).
can be expressed as a number and a reference. 3.2.23 Type A evaluation of measurement uncertainty [VIM,
3.2.16 quantity value [VIM, 1.19]—number and reference 2.28]—evaluation of a component of measurement uncertainty
together expressing magnitude of a quantity. by a statistical analysis of measured quantity values obtained
under defined measurement conditions.
3.2.16.1 Discussion—For example, absorbed dose of 25
3.2.24 Type B evaluation of measurement uncertainty [VIM,
kGy.
3.2.17 repeatability (of results of measurements) [GUM, 2.29]—evaluation of a component of measurement uncertainty
B.2.15]—closeness of the agreement between the results of determined by means other than a Type A evaluation of
successive measurements of the same measurand carried out measurement uncertainty.
under the same conditions of measurement. 3.2.25 uncertainty budget [VIM, 2.33]—statement of a mea-
3.2.17.1 Discussion— surement uncertainty, of the components of that measurement
(1) These conditions are called ‘repeatability conditions’. uncertainty, and of their calculation and combination.
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ISO/ASTM 51707:2015(E)
3.2.25.1 Discussion—An uncertainty budget should include measurand, the method of measurement, the measurement
the measurement model, estimates, and measurement uncer- system and the measurement procedure.
tainties associated with the quantities in the measurement 5.1.2 In general, the result of a measurement is the approxi-
model, covariances, type of applied probability density mation or best estimate of the true value of the measurand
functions, degrees of freedom, type of evaluation of measure- (dose) and thus is complete only when accompanied by a
ment uncertainty, and any coverage factor. statement of the uncertainty of that estimate.
3.3 Definitions of other terms used in this standard that 5.2 Uncertainty:
pertain to quality and statistics may be found in ASTM 5.2.1 The uncertainty of the measurement result reflects the
Terminology E456. Definitions of other terms used in this inability to know the true value of the measurand. A lower
standard that pertain to radiation measurement and dosimetry value of overall uncertainty reflects a higher degree of confi-
may be found in ASTM Terminology E170. Definitions in dence in the estimate of the value of the measurand.
ASTM Terminology E170 are compatible with ICRU 85a; that NOTE 2—The result of any individual measurement can unknowingly
document, therefore, may be used as an alternative reference. be very close to the value of the measurand even though it may have a
large uncertainty. Thus the uncertainty of a measurement result should not
4. Significance and use be confused as the unknown error.
4.1 All measurements, including dose measurements, have 5.2.2 The uncertainty associated with a measurement can
an associated uncertainty. The magnitude of the measurement arise from a number of different components, examples of
uncertainty is important for assessing the quality of the results some of which are listed in Section 7. In assessing measure-
of the measurement system. ment uncertainty, it is necessary to consider all steps associated
with making a measurement and assign to each step a value for
4.2 Information on the range of achievable uncertainty
the uncertainty introduced. These individual components can
values for specific dosimetry systems is given in the ISO/
then be collected together to produce a combined uncertainty
ASTM standards for the specific dosimetry systems. While the
for the measurement. The results of this type of analysis are
uncertainty values given in specific dosimetry standards are
often presented in the form of a table, referred to as an
achievable, it should be noted that both smaller and larger
uncertainty budget (see Annex A2). Components of uncertainty
uncertainty values might be obtained depending on measure-
are generally classified as Type A or Type B, depending on the
ment conditions and instrumentation. For more information see
method used to evaluate them.
also ISO/ASTM 52628.
5.2.2.1 The purpose of the Type A and Type B classification
4.3 This guide uses the methodology adopted by the GUM is to indicate the two different ways of evaluating uncertainty
for estimating uncertainties in measurements (see 2.4). components. Both types of evaluation are based on probability
Therefore, components of uncertainty are evaluated as either distributions and the uncertainty components resulting from
Type A uncertainty or Type B uncertainty. each type are quantified by a standard deviation or a variance.
4.4 Quantifying individual components of uncertainty may 5.2.2.2 Thus, a Type A standard uncertainty is obtained from
assist the user in identifying actions to reduce the measurement a probability density function derived from a series of repeated
uncertainty. observations (see 8.1), while a Type B standard uncertainty is
obtained from an assumed probability density function based
4.5 Periodically, the uncertainty should be reassessed to on the degree of belief that an event will occur (see 8.2). Both
confirm the existing estimate. Should changes occur that could approaches are valid interpretations of probability.
influence the existing component estimates or result in the 5.2.3 The combined standard uncertainty, denoted by uc, of
addition of new components of uncertainty, a new estimate of the result of a measurement is obtained by combining all the
uncertainty should be established. components of uncertainty of both categories (see 9.1.1).
4.6 Although this guide provides a framework for assessing 5.2.4 Typically, an expanded uncertainty U is calculated to
uncertainty, it cannot substitute for critical thinking, intellec- provide an interval about the result of a measurement within
tual honesty, and professional skill. The evaluation of uncer- which the true value is expected to lie. The value of U is
tainty is neither a routine task nor a purely mathematical one; obtained by multiplying the combined standard uncertainty uc
it depends on detailed knowledge of the nature of the mea- by a coverage factor k (see 9.2).
surand and of the measurement method and procedure used.
NOTE 3—The coverage factor k is always to be stated when reporting
The quality and utility of the uncertainty quoted for the result expanded uncertainty, so that the combined standard uncertainty of the
of a measurement therefore ultimately depends on the measured quantity can be recovered.
understanding, critical analysis, and integrity of those who
contribute to the assignment of its value (JCGM 100:2008). 6. Evaluation of Type A and Type B standard
uncertainty
5. Basic concepts—components of uncertainty 6.1 Measurement Procedure:
5.1 Measurement: 6.1.1 The measurand Y (absorbed dose) is generally not
5.1.1 The objective of a measurement is to determine the measurable directly, but depends on N other quantities X1, X2,
value of the measurand (for example, dose), that is, the value ..., XN through a functional relationship: Y5f ~ X 1 , X 2 , …, X N ! .
of the specific quantity to be measured (dose). A measurement 6.1.1.1 The input quantities X1, X2, ... XN and their associ-
therefore begins with an appropriate specification of the ated uncertainties may be determined directly in the current
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ISO/ASTM 51707:2015(E)
measurement process by means of repeated observations (such humidity have significant effects on measured absorbance. Controlling
as Type A); these input quantities may include influence these influence quantities during calibration and routine dosimetry will
reduce the uncertainty in dose estimates.
quantities such as temperature or humidity. They may also
involve input quantities related to activities such as calibration 6.3 Type B Evaluation of Standard Uncertainty:
of routine dosimetry systems under conditions that differ from 6.3.1 The Type B component of uncertainty is evaluated by
those during use (different dose rates, temperature cycle, etc.). using all relevant information on the possible variability of the
Other quantities that may be involved are those due to use of input quantities Xi. For the input value Xi that has not been
reference or transfer standard dosimeters. obtained from repeated measurements, the estimated variance,
6.1.1.2 The input quantities X1, X2, X3 ... XN and associated uB2, or standard uncertainty, uB, is evaluated by judgment using
uncertainties may be treated either individually, for example, all relevant information on the possible variability of Xi. This
X1 or X2 or as aggregates, for example, (X1 ... Xp) where p < N. pool of information may include previous measurement data or
6.1.1.3 Grouping of input quantities is determined by the documented performance characteristics of the dosimetry sys-
characteristics of the selected dosimetry system, method of tem. The uncertainty estimated in this way is referred to as a
calibration, measurement application environment, and the Type B standard uncertainty, uB.
ability within these sets of conditions to generate experimental 6.3.2 Several methods may be used to develop estimates of
measurements either for individual or aggregate input quanti- the magnitude of Type B standard uncertainty. One method
ties. estimates the maximum magnitude likely to be observed for
6.1.1.4 Both individual and aggregate input quantities may each input quantity. For example, if the dosimeter response is
be used to estimate the combined standard uncertainty. known to vary with irradiation temperature, then the tempera-
6.2 Type A Evaluation of Standard Uncertainty: ture range routinely seen in operation should be used to
estimate this component of uncertainty. If there is no specific
6.2.1 Type A evaluations of uncertainty are made by statis-
knowledge about the possible values of Xi within its estimated
tical analysis of a series of measurement results of a quantity
bounds of a– to a+, it is assumed that it is equally probable for
value.
Xi to take on any value within those bounds (that is a
6.2.2 In most cases, the best estimate of the expected value
rectangular distribution, see Fig. 2). As stated in JCGM
of a quantity is obtained by n independent measurements made
100:2008 (GUM), the sample standard deviation is a/√3 for
under repeatability conditions and is given by the arithmetic
such a distribution. In some cases it is more realistic to expect
mean, x̄, or average of those measurement results. The sample
that values near the bounds are less likely than those near the
standard deviation, s, of these observations characterizes the
midpoint. It may then be reasonable to replace the rectangular
variability of the observed values or their dispersion about their
distribution with a symmetric triangular distribution with a
mean. The standard uncertainty of the mean value is given by
base width of a+ – a– = 2a, see Fig. 2. Assuming such a
s/√n. Therefore, for Type A components of uncertainty, increas-
triangular distribution for Xi, the expectation value of Xi is (a–
ing the number of measurements will reduce the standard
+ a+)/2 and its variance is a2/6. Thus, the Type B standard
uncertainty of the mean.
uncertainty, uB = a/√6 (see JCGM 100:2008 (GUM)).
6.2.3 In cases where only a single, or very few, measure-
6.3.3 It is important not to “double-count” uncertainty
ments are made, the estimate of the sample standard deviation
components. For example, if a component of uncertainty
has to be taken from prior measurements made using the same
arising from a particular effect is obtained from a Type B
dosimetry system. The sample standard deviation could be
evaluation, it should be included as an independent component
determined from a single set of prior measurements, or derived
of uncertainty in the calculation of the combined standard
as a pooled standard deviation from several sets of prior
uncertainty of the measurement result only to the extent that
measurements.
the effect does not contribute to the observed variability of the
NOTE 4—See GUM H.3.6 for further information on pooled variance observations. This is because the uncertainty due to that
and pooled standard deviation. portion of the effect that contributes to the observed variability
NOTE 5—Repeatability of dosimeter response is an example of a Type is already included in the component of uncertainty obtained
A component of uncertainty that is usually determined from a set, or sets,
of prior measurements. from the statistical analysis of the observations (GUM 4.3.10).
6.2.4 The Type A standard uncertainties are determined by 7. Examples of uncertainty budget components
the experimental design that is used to collect the observations associated with absorbed dose measurements
for the uncertainty estimate. If the estimated Type A uncer-
NOTE 7— See also ISO/ASTM 51261 and ISO/ASTM 52701 for
tainty is unacceptably large, the individual components of additional details.
uncertainty may be estimated by a more refined experimental
design. Knowledge of the components contributing to the 7.1 Components of the combined uncertainty in the mea-
estimated uncertainty might allow identification of components sured values of absorbed dose which are identified and
that can be controlled so as to reduce uncertainty. characterized during the dosimetry system calibration include
the following:
NOTE 6—For example, if optical absorbance of a film dosimeter is 7.1.1 Uncertainty in the absorbed dose reported by the
measured during calibration without controlling film thickness, relative
humidity, or temperature, the uncertainty of dose estimates from this approved laboratory. During calibration irradiations, the dose
calibration may be unacceptably large. An experimental design that to dosimeters that was delivered or measured by an approved
controls these factors may indicate the film thickness and relative laboratory is subject to uncertainty. The uncertainty of this dose
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ISO/ASTM 51707:2015(E)
value is obtained from the certificate from the approved 7.2.4 Time of Response Measurement after Irradiation—
laboratory. This component of uncertainty estimate may in- The response of some dosimeters might not be stable with time
clude: after irradiation. The time of measurement is usually specified
7.1.1.1 Response of primary or reference standard, to be within a given range. Variation in time within this range
7.1.1.2 Irradiation time of the calibration dosimeters, may give rise to uncertainty of dosimeter response. This
7.1.1.3 Gamma source decay corrections, component of uncertainty may be evaluated as Type B uncer-
7.1.1.4 Non-uniformities in the reference standard irradia- tainty.
tion field, 7.2.5 Instrument Stability—Information about stability of
7.1.1.5 Corrections for attenuation and irradiation geometry. measurement instruments can be obtained from characteriza-
7.1.2 Uncertainty in dosimeter response measurements. The tion measurement using standard reference materials, such as
uncertainty of the response of the dosimeters is obtained from optical filters in case of spectrophotometers. This component
the measurement of dosimeters irradiated during calibration to of uncertainty may be evaluated as either a Type A or Type B
the same doses. This component of uncertainty is evaluated as uncertainty.
a Type A uncertainty from the statistical analysis of repeated 7.3 Each example of uncertainty may consist of several
dosimeter response measurements. This component of uncer- components of both Type A and Type B. The Type A contri-
tainty estimate may include: butions are combined with the Type B contributions to give a
7.1.2.1 Intrinsic variation in dosimeter response, combined standard uncertainty.
7.1.2.2 Variation in thickness/mass of individual
dosimeters, 8. Characterization of uncertainty components based on
7.1.2.3 Measurement of thickness/mass of individual probability distributions
dosimeters,
7.1.2.4 Variations in performance of measurement equip- 8.1 Normal Distribution:
ment (including dosimeter positioning). 8.1.1 The normal (or Gaussian) distribution, shown in Fig.
7.1.3 Uncertainty in fitting a calibration curve. The uncer- 1, is a continuous probability distribution that has a bell-shaped
tainty arising from fitting the measurement results to a calibra- probability density function, known as the Gaussian function
tion curve can be obtained from the residuals, i.e. the difference or informally as the bell curve:
between doses calculated using the calibration curve and doses
actually applied during calibration. This component of uncer- f ~ x ; µ , σ 2! 5
1
e2 2 σS
1 x2µ
D 2
(4)
σ =2π
tainty may be evaluated as a Type A uncertainty. This compo-
nent of uncertainty estimate may include: The parameter µ is the mean or expected value; a value
7.1.3.1 Variation in response of dosimeters, within the range with the highest likelihood or frequency of
7.1.3.2 Analytical function used in fit. observation (location of the peak) and σ2 represents the
expected variation about the mean value. σ is known as the
7.2 Contributions to the combined uncertainty in the mea-
standard deviation. The standard deviation in the normal
sured values of absorbed dose that arise from influence
quantities relevant during routine use of dosimeters that are distribution characterizes a range of values about the mean that
different from the calibration conditions may include the represents approximately 68 % of the population values. The
following: distribution with µ=0 and σ2=1 is called the standard normal
distribution or the unit normal distribution. A normal distribu-
7.2.1 Dosimeter Storage Conditions (temperature and
tion is often used as a first approximation to describe real-
humidity)—The temperature and humidity at which dosimeters
valued random variables that cluster around a single mean
are stored will usually be defined as a range. Dispersion of
value (JCGM 100:2008).
dosimeter response values caused by variation in temperature
and humidity within this range may give rise to uncertainty of 8.1.2 Examples of individual components of uncertainty
dosimeter response. This component of uncertainty may be arising from assumed normal distributions are:
evaluated as Type B uncertainty. 8.1.2.1 Uncertainty of Dosimeter Response Values—Dose
7.2.2 Dosimeter Temperature and Humidity during measurement uncertainty from variation of the dosimeter
Irradiation—The temperature and humidity at which dosim- response for repeated measurements at given dose level results
eters are irradiated will usually be known within a given range. in a corresponding uncertainty in calculated dose (see A1.1).
Uncertainties in response caused by variation in temperature Dosimeters irradiated to the same dose will exhibit intrinsic
and humidity within this range may give rise to uncertainty of variability in their response that can be characterized and
dosimeter response. This component of uncertainty may be statistically analyzed, and therefore this component of uncer-
evaluated as Type B uncertainty. tainty may be evaluated as a Type A uncertainty based on a
7.2.3 Dosimeter Thickness or Mass—The thickness or mass normal distribution.
of dosimeters might be determined by measurement, in which 8.1.2.2 Uncertainty Arising from Instrument Instability—
case this component of uncertainty is evaluated as a Type A Variation of repeated measurements of the same dosimeter for
uncertainty. Dosimeter thickness or mass might also be con- the same instrument results in a corresponding uncertainty in
sidered to be within a range, in which case this component of calculated dose. The ability of measurement equipment to
uncertainty may be evaluated as Type B uncertainty. deliver repeated values can be characterized and statistically
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FIG. 1 Normal distribution, also called Gaussian or “bell curve”, the most important continuous random distribution (JCGM 100:2008)
analyzed, and therefore this component of uncertainty may be 8.2.2 Examples of approaches to evaluating the contribu-
evaluated as a Type A uncertainty based on a normal distribu- tion of an individual component of uncertainty using assumed
tion. rectangular probability distributions:
8.1.2.3 Uncertainty of Dosimeter Thickness or Mass 8.2.2.1 Temperature (storage or irradiation)—Temperature
Values—Measurement uncertainty arising from the variation of at which dosimeters are stored or the temperature at which
an assumed value of dosimeter thickness or mass that results in dosimeters are irradiated is usually defined as a range. Each
a corresponding uncertainty in calculated dose. Dosimeter value in the range is assumed to have the same probability of
batches are usually comprised of a range of thicknesses or occurrence and thus, this component of uncertainty is evalu-
masses and are identified by the average for that range. The ated as a Type B uncertainty based on a rectangular distribu-
variability within the range can be characterized and statisti- tion.
cally analyzed, and therefore this component of uncertainty 8.2.2.2 Humidity (storage or irradiation)—Humidity at
may be evaluated as a Type A uncertainty based on a normal which dosimeters are stored or the humidity at which dosim-
distribution. eters are irradiated is usually defined as a range. Each humidity
8.2 Rectangular Distribution: level in the range is assumed to have the same probability of
8.2.1 The continuous uniform distribution or rectangular occurring and thus, this component of uncertainty is evaluated
distribution is a probability distribution where all values are at a Type B uncertainty based on a rectangular distribution.
equally probable within specified limits; a– and a+, which are 8.2.2.3 Dosimeter Thickness or Mass—Unless the batch of
its minimum and maximum values (JCGM 100:2008). dosimeters is assessed with a sampling of the thickness or mass
FIG. 2 Rectangular distribution, also called continuous uniform distribution (JCGM 100:2008)
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distribution, each value of thickness or mass within the batch 9.2.2.1 The level of confidence is an estimate of the prob-
range should be assumed to have the same probability of ability that the true value will fall within the given range of the
occurrence and therefore the component of uncertainty is expanded uncertainty about the measured value.
evaluated as a Type B uncertainty based on a rectangular
9.3 Statement of Uncertainty for the Measurement Result:
distribution.
9.3.1 It is typical to form a statement of uncertainty based
NOTE 8—These are two of many different types of probability distri- on the expanded uncertainty estimate for k=2. This statement is
butions that can be used. The choice of distribution is dependent on the to be used in conjunction with all measurements associated
ability to quantify the influence quantity.
with the validated measurement system, including well char-
8.3 In order to combine different uncertainty components, acterized test methods.
all components should be in the same form, for example, EXAMPLE: An example of a statement of uncertainty for
relative standard uncertainty. measurements using a PMMA dosimetry system is as follows:
8.4 Examples of uncertainty calculations can be found in “The reported doses are based on measurements using a
Annex A1. calibrated dosimetry system operated in compliance with
ISO/ASTM 52628, ISO/ASTM 52701, ISO/ASTM 51261 and
9. Statement of uncertainty ISO/ASTM 51276. The expanded uncertainty associated with
these measurements is X.Y % at a level of confidence approxi-
9.1 Combined Standard Uncertainty:
mately 95 %.”
9.1.1 For sources of uncertainty that are independent (not
correlated), the combined standard uncertainty is obtained by 9.3.2 The summary statement should be supported by an
combining all components (Type A and Type B) of standard uncertainty assessment practice or document containing com-
uncertainties in quadrature ~ u c 5= ~ u 21 1 u 22 1 u 23 1 ...!! . If ab- prehensive uncertainty assessment detail. The JCGM 100
solute values are used for the standard uncertainties, the (GUM) recommends the documentation should include the
components of uncertainty must be weighted by appropriate following information:
sensitivity coefficients. This combined standard uncertainty is (a) Describe clearly the methods used to derive the mea-
designated as uc. surement result and its uncertainty from the experimental
observations and input data;
9.1.2 For sources of uncertainty that are correlated, the (b) List all uncertainty components and document fully
effects of those correlations must be taken into account in how they were evaluated (that is, uncertainty budget);
determining the combined standard uncertainty. Full treatment (c) Present the data analysis in such a way that each of its
of correlation effects is beyond the scope of this guide. important steps can be readily followed and the calculation of
Guidance is given in GUM. the reported result can be independently repeated, if necessary;
NOTE 9—In the special case where input quantities are perfectly (d) Give all corrections and constants used in the analysis
correlated, the combined standard uncertainty is the linear sum of all the and their sources.
standard uncertainty components (1).8 This has the effect of giving a
maximum limit to the estimate of the combined standard uncertainty. 10. Uses of measurement uncertainty estimates
9.2 Expanded Uncertainty:
10.1 The estimated value of expanded uncertainty serves as
9.2.1 Although uc can be used as the expression of uncer- a guide for determining if the measurement system is appro-
tainty of a measurement result, it is often necessary to give the priate for the intended use.
uncertainty in terms of an interval about the measurement
NOTE 11—Adherence to industry standards, such as ISO/ASTM 52628,
result within which the dose values that could reasonably be ISO/ASTM 52701, ISO/ASTM 51261 and applicable dosimetry system
attributed to the measurand (dose estimate) are expected to lie practices, will help ensure the dosimetry system measurements are of
with a high level of confidence. This additional measure of good metrological quality.
uncertainty is termed expanded uncertainty and denoted as U. 10.2 Performance of the detailed analysis of the components
The expanded uncertainty U is obtained by multiplying the contributing to the expanded uncertainty through the develop-
combined standard uncertainty uc by a coverage factor k: ment of an uncertainty budget has the following benefits.
U 5 ku c (5) 10.2.1 Identification of possible sources of uncertainty and
9.2.2 Dose measurement uncertainty is commonly ex- assessment of the effects of these lessen the chance that the
pressed for a coverage factor k=2 (two standard deviations) measurement will be influenced in an unknown way.
providing about 95 % level of confidence. 10.2.2 Components of uncertainty that may be unacceptably
large can be identified, which may help identify improvements
NOTE 10—The choice of a coverage factor that corresponds to an exact in the measurement techniques.
level of confidence is difficult to make in practice. This is true because it
requires the full knowledge of the probability distribution of the estimate 10.2.3 Variability in measured dose values may be caused
of the measurements. In practice, coverage factors of 2 and 3 approximate by uncertainty related to the dosimetry system and by variabil-
a 95 % and 99 % level of confidence, respectively. ity in the irradiation process. Without knowledge of the
components of uncertainty related to the measurement system
it is not possible to differentiate between the two potential
8
The boldface numbers in parentheses refer to the corresponding reference in the sources of variability. Knowledge of the components of uncer-
bibliogrpahy at the end of this guide. tainty in measurements of absorbed dose has practical value
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ANNEXES
Informative
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A2.1 An example of an uncertainty budget listing the uncertainty budget represents the uncertainty associated with
components of uncertainty is given below, and it should be measurements using a calibrated traceable dosimetry system,
taken only as a guide to forming an uncertainty budget. This based on an in-plant calibration. See Table A2.1.
TABLE A2.1
Probability Relative standard uncertainty
Component of uncertainty Value
distribution Type A Type B
Calibration doses from laboratory certificate 1.3 % Normal 1.3 %
Fit of calibration curve 0.8 % Normal 0.8 %
Dosimeter response variability due to irradiation temperature 1.0 % Rectangular 0.6 %
Difference in dose to reference and calibration dosimeters 1.0 % Rectangular 0.6 %
Dosimeter-to-dosimeter scatter (repeatability) 1.4 % Normal 1.4 %
Combined uncertainty 2.2 %
Expanded uncertainty (k=2) 4.4 %
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TABLE A2.2
Relative uncertainties. Values at 1 s.d. (k = 1) except as noted.
Measurement instrument: EPR spectrometer EMS-104
Calibration of alanine pellet dosimeters at gamma facility
Probability distribution Type A Type B
Doses given during calibration Normal 1.41
EPR spectrometer stability Normal 0.25
Homogeneity of pellets Rectangular 0.05
Alanine pellet mass measurement Normal 0.15
Response measurement
reproducibility Normal 0.25
angle Normal 0.10
height Normal 0.15
Irradiation geometry Rectangular 0.15
Establish calibration function Normal 0.25
Combined uncertainty of calibration 1.50
Measurement with alanine pellet dosimeters at gamma
Probability distribution Type A Type B
Response measurement Normal 0.31
EPR spectrometer stability Normal 0.25
Alanine pellet mass measurement Normal 0.15
Temperature correction Rectangular 0.15
Reproducibility of measurement (combined) 0.45
BIBLIOGRAPHY
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