ASTM ISO/ASTM51939-17(2022)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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 51939:2017 (Reapproved 2022)(E)
Standard Practice for
Blood Irradiation Dosimetry
This standard is issued under the fixed designation ISO/ASTM 51939; 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 mendations issued by the World Trade Organization Technical
Barriers to Trade (TBT) Committee.
1.1 This practice outlines the irradiator installation qualifi-
cation program and the dosimetric procedures to be followed
2. Referenced documents
during operational qualification and performance qualification
2.1 ASTM Standards:
of the irradiator. Procedures for the routine radiation process-
E170 Terminology Relating to Radiation Measurements and
ing of blood product (blood and blood components) are also
Dosimetry
given. If followed, these procedures will help ensure that blood
2.2 ISO/ASTM Standards:
product exposed to gamma radiation or X-radiation
51026 Practice for Using the Fricke Dosimetry System
(bremsstrahlung) will receive absorbed doses with a specified
51261 Practice for Calibration of Routine Dosimetry Sys-
range.
tems for Radiation Processing
1.2 This practice covers dosimetry for the irradiation of
51275 Practice for Use of a Radiochromic Film Dosimetry
blood product for self-contained irradiators (free-standing
System
137 60
irradiators) utilizing radionuclides such as Cs and Co, or
51310 Practice for Use of a Radiochromic Optical Wave-
X-radiation (bremsstrahlung). The absorbed dose range for
guide Dosimetry System
blood irradiation is typically 15 Gy to 50 Gy.
51539 Guide for the Use of Radiation-Sensitive Indicators
51607 Practice for Use of the Alanine-EPR Dosimetry Sys-
1.3 The photon energy range of X-radiation used for blood
tem
irradiation is typically from 40 keV to 300 keV.
51707 Guide for Estimating Uncertainties in Dosimetry for
1.4 This practice also covers the use of radiation-sensitive
Radiation Processing
indicators for the visual and qualitative indication that the
51956 Practice for Use of Thermoluminescence-Dosimetry
product has been irradiated (see ISO/ASTM Guide 51539).
Systems (TLD Systems) for Radiation Processing
1.5 This document is one of a set of standards that provides
52116 Practice for Dosimetry for a Self-Contained Dry-
recommendations for properly implementing dosimetry in
Storage Gamma-Ray Irradiator
radiation processing and describes a means of achieving
52628 Practice for Dosimetry in Radiation Processing
compliance with the requirements of ISO/ASTM Practice
52701 Guide for Performance Characterization of Dosim-
52628 for dosimetry performed for blood irradiation. It is
eters and Dosimetry Systems for Use in Radiation Pro-
intended to be read in conjunction with ISO/ASTM Practice
cessing
52628.
2.3 International Commission on Radiation Units and Mea-
surements Reports (ICRU):
1.6 This standard does not purport to address all of the
ICRU 80 Dosimetry Systems for Use in Radiation Process-
safety concerns, if any, associated with its use. It is the
ing
responsibility of the user of this standard to establish appro-
ICRU 85a Fundamental Quantities and Units for Ionizing
priate safety, health, and environmental practices and deter-
Radiation
mine the applicability of regulatory limitations prior to use.
2.4 ISO Standards:
1.7 This international standard was developed in accor-
12749-4 Nuclear energy – Vocabulary – Part 4: Dosimetry
dance with internationally recognized principles on standard-
for radiation processing
ization established in the Decision on Principles for the
Development of International Standards, Guides and Recom-
For referenced ASTM and ISO/ASTM standards, visit the ASTM website,
www.astm.org, or contact ASTM Customer Service at service@astm.org. For
This practice is under the jurisdiction of ASTM Committee E61 on Radiation Annual Book of ASTM Standards volume information, refer to the standard’s
Processing and is the direct responsibility of Subcommittee E61.04 on Specialty Document Summary page on the ASTM website.
Application, and is also under the jurisdiction of ISO/TC 85/WG 3. Available from the International Commission on Radiation Units and
Current edition approved June 1, 2022. Published September 2022. Originally Measurements, 7910 Woodmont Ave., Suite 800, Bethesda, MD 20814 U.S.A.
published as ASTM E 1939–98. Last previous ASTM edition E 1939–98. The Available from International Organization for Standardization (ISO), ISO
present International Standard ISO/ASTM 51939:2017(2022)(E) is a reapproval of Central Secretariat, BIBC II, Chemin de Blandonnet 8, CP 401, 1214 Vernier,
the last previous edition ISO/ASTM 51939:2017(E). Geneva, Switzerland, http://www.iso.org.
© ISO/ASTM International 2024 – All rights reserved
ISO/ASTM 51939:2017 (2022)(E)
2.5 ISO/IEC Standards: 3.1.4 activity (A) (of an amount of radionuclide in a
17025 General Requirements for the Competence of Testing particular energy state at a given time)—quotient of –dN by dt,
and Calibration Laboratories where dN is the mean change in the number of nuclei in that
energy state due to spontaneous nuclear transitions in the time
2.6 Guidelines on Blood Irradiation:
interval dt (see ICRU 85a).
Guidelines on the Use of Irradiated Blood Components
(2013), Prepared by the BCSH Blood Transfusion Task A 5 2dN/dt (3)
Force
−1
Unit: s
Recommendations Regarding License Amendments and
The special name for the unit of activity is the becquerel
Procedures for Gamma Irradiation of Blood Products,
−1
(Bq). 1 Bq = 1 s .
(1993) US Food and Drug Administration
3.1.4.1 Discussion—
Guidance for Industry, Gamma Irradiation of Blood and
(1) The former special unit of activity was the curie (Ci).
Blood Components: A Pilot Program for Licensing (2000)
10 −1
1 Ci = 3.7 × 10 s (exactly).
US Food and Drug Administration
(2) The ‘particular energy state’ is the ground state of the
2.7 Joint Committee for Guides in Metrology (JCGM)
nuclide unless otherwise specified.
Reports:
(3) The activity of an amount of radionuclide in a particular
JCGM 100:2008 GUM 1995, with minor corrections, Evalu-
energy state is equal to the product of the decay constant, λ, for
ation of measurement data – Guide to the expression of
that state and the number of nuclei in that state (that is, A=Nλ).
uncertainty in measurement
3.1.5 approved laboratory—laboratory that is a recognized
JCGM 200:2012 (JCGM 200:2008 with minor revisions),
national metrology institute; or has been formally accredited to
VIM, International vocabulary of metrology – Basis and
ISO/IEC 17025; or has a quality system consistent with the
general concepts and associated terms
requirements of ISO/IEC 17025.
3.1.5.1 Discussion—A recognized national metrology insti-
3. Terminology
tute or other calibration laboratory accredited to ISO/IEC
3.1 Definitions:
17025 should be used in order to ensure traceability to a
3.1.1 absorbed dose (D)—quotient of dɛ¯ by dm, where dɛ¯ is
national or international standard. A calibration certificate
the mean energy imparted by ionizing radiation to matter of
provided by a laboratory not having formal recognition or
mass dm (see ICRU 85a).
accreditation will not necessarily be proof of traceability to a
D 5 dε¯/dm (1)
national or international standard.
3.1.1.1 Discussion—The SI unit of absorbed dose is the gray
3.1.6 bremsstrahlung—broad-spectrum electromagnetic ra-
(Gy), where 1 gray is equivalent to the absorption of 1 joule per
diation emitted when an energetic charged particle is influ-
kilogram of the specified material (1 Gy = 1 J/kg).
enced by a strong electric or magnetic field, such as that in the
˙
3.1.2 absorbed-dose rate (D)—quotient of dD by dt, where
vicinity of an atomic nucleus.
dD is the increment of absorbed dose in the time interval dt,
3.1.6.1 Discussion—
thus
(1) In radiation processing, bremsstrahlung photons with
˙
D 5 dD/dt (2)
sufficient energy to cause ionization are generated by the
–1
3.1.2.1 Discussion—The SI unit is Gy·s . However, the
deceleration or deflection of energetic electrons in a target
absorbed-dose rate is often specified in terms of its average
material. When an electron passes close to an atomic nucleus,
value over longer time intervals, for example, in units of
the strong coulomb field causes the electron to deviate from its
–1 –1
Gy·min or Gy·h .
original motion. This interaction results in a loss of kinetic
energy by the emission of electromagnetic radiation. Since
3.1.3 absorbed-dose mapping—measurement of absorbed
such encounters are uncontrolled, they produce a continuous
dose within an irradiated product to produce a one, two, or
photon energy distribution that extends up to the maximum
three-dimensional distribution of absorbed dose, thus rendering
kinetic energy of the incident electron.
a map of absorbed-dose values.
(2) The bremsstrahlung spectrum depends on the electron
3.1.3.1 Discussion—For a blood canister, such a dose map is
energy, the composition and thickness of the target, and the
obtained using dosimeters placed at specified locations within
angle of emission with respect to the incident electron.
the canister.
3.1.7 calibration—set of operations that establish under
specified conditions, the relationship between values of quan-
tities indicated by a measuring instrument or measuring
Available from the National Blood Transfusion Service, East Anglian Blood
Transfusion Centre, Long Road, Cambridge, CB2 2PT United Kingdom.
system, or values represented by a material measure or a
Available from the Office of Communication, Training and Manufacturers
reference material, and the corresponding values realized by
Assistance (HFM-40), 1401 Rockville Pike, Rockville, MD 20852-1488, USA.
7 standards.
Document produced by working Group 1 of the Joint Committee for Guides in
Metrology (JCGM WG1). Available free of charage at the BIPM website (http://
3.1.7.1 Discussion—Calibration conditions include environ-
www.bipm.org).
mental and irradiation conditions present during irradiation,
Document produced by working Group 2 of the Joint Committee for Guides in
storage and measurement of the dosimeters that are used for the
Metrology (JCGM WG2). Available free of charge at the BIPM website (http://
www.bipm.org). generation of a calibration curve.
© ISO/ASTM International 2022 – All rights reserved
ISO/ASTM 51939:2017 (2022)(E)
3.1.8 dosimeter—device that, when irradiated, exhibits a (1) Simulated product is used during irradiator character-
quantifiable change that can be related to absorbed dose in a ization as a substitute for the actual product, material or
given material using appropriate measurement instruments and substance to be irradiated.
procedures. (2) When used in routine production runs in order to
compensate for the absence of product, simulated product is
3.1.9 dosimeter batch—quantity of dosimeters made from a
sometimes referred to as compensating dummy.
specific mass of material with uniform composition, fabricated
(3) When used for absorbed-dose mapping, simulated
in a single production run under controlled, consistent condi-
product is sometimes referred to as phantom material.
tions and having a unique identification code.
3.1.21 timer setting—defined time interval during which
3.1.10 dosimetry system—system used for measuring ab-
product is exposed to radiation.
sorbed dose, consisting of dosimeters, measurement instru-
3.1.22 transfer-standard dosimetry system—dosimetry sys-
ments and their associated reference standards, and procedures
tem used as an intermediary to calibrate other dosimetry
for the system’s use.
systems.
3.1.11 installation qualification (IQ)—process of obtaining
3.1.23 transit dose—absorbed dose delivered to a product
and documenting evidence that equipment has been provided
(or a dosimeter) while it travels between the non-irradiation
and installed in accordance with specifications.
position and the irradiation position, or in the case of a
3.1.12 irradiator turntable—device used to rotate the
movable source while the source moves into and out of its
sample during the irradiation process so as to improve dose
irradiation position.
uniformity.
3.1.24 validation—documented procedure for obtaining, re-
3.1.12.1 Discussion—An irradiator turntable is often re-
cording and interpreting the results to establish that a process
ferred to as a turntable. Some irradiator geometries, for
will consistently yield product complying with predetermined
example with a circular array of radiation sources surrounding
specifications.
the product, may not need a turntable.
3.1.25 X-radiation—ionizing electromagnetic radiation
3.1.13 isodose curves—lines or surfaces of constant ab-
which includes both bremsstrahlung and the characteristic
sorbed dose through a specified medium.
radiation emitted when atomic electrons make transitions to
3.1.14 measurement management system—set of interre-
more tightly bound states.
lated or interacting elements necessary to achieve metrological
3.1.25.1 Discussion—In radiation processing applications
confirmation and continual control of measurement processes.
(such as blood product irradiation), the principal X-radiation is
3.1.15 operational qualification (OQ)—process of obtaining
bremmstrahlung.
and documenting evidence that installed equipment operates
3.1.26 X-ray converter—device for generating X-radiation
within predetermined limits when used in accordance with its
(bremsstrahlung) from an electron beam, consisting of a target,
operational procedures.
means for cooling the target, and a supporting structure.
3.1.16 performance qualification (PQ)—process of obtain-
3.2 Definitions of Terms Specific to This Standard:
ing and documenting evidence that the equipment as installed
3.2.1 blood product (blood and blood components)—whole
and operated in accordance with operational procedures, con-
blood, red cells, frozen cells, platelet concentrates, apheresis
sistently performs in accordance with predetermined criteria
platelets, granulocyte concentrates, and fresh or frozen plasma.
and thereby yields product that meeting its specification.
3.2.1.1 Discussion—Enclosure systems for blood and blood
3.1.17 radiation-sensitive indicator—material such as a
components are commonly referred to as “bags.”
coated or impregnated adhesive-backed substrate, ink, coating
3.2.2 canister—container used to house the blood product or
or other material which may be affixed to or printed on the
blood-equivalent product during the irradiation process.
product and which undergoes a visual change when exposed to
3.3 Definitions of other terms used in this standard that
ionizing radiation.
pertain to radiation measurement and dosimetry
...

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 51939:2017(E)
ISO/ASTM 51939 − 2017 (Reapproved 2022)(E)
Standard Practice for
Blood Irradiation Dosimetry
This standard is issued under the fixed designation ISO/ASTM 51939; 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 practice outlines the irradiator installation qualification program and the dosimetric procedures to be followed during
operational qualification and performance qualification of the irradiator. Procedures for the routine radiation processing of blood
product (blood and blood components) are also given. If followed, these procedures will help ensure that blood product exposed
to gamma radiation or X-radiation (bremsstrahlung) will receive absorbed doses with a specified range.
1.2 This practice covers dosimetry for the irradiation of blood product for self-contained irradiators (free-standing irradiators)
137 60
utilizing radionuclides such as Cs and Co, or X-radiation (bremsstrahlung). The absorbed dose range for blood irradiation is
typically 15 Gy to 50 Gy.
1.3 The photon energy range of X-radiation used for blood irradiation is typically from 40 keV to 300 keV.
1.4 This practice also covers the use of radiation-sensitive indicators for the visual and qualitative indication that the product has
been irradiated (see ISO/ASTM Guide 51539).
1.5 This document is one of a set of standards that provides recommendations for properly implementing dosimetry in radiation
processing and describes a means of achieving compliance with the requirements of ISO/ASTM Practice 52628 for dosimetry
performed for blood irradiation. It is intended to be read in conjunction with ISO/ASTM Practice 52628.
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 safety, health, and healthenvironmental practices and to determine the
applicability orof regulatory limitations prior to use.
1.7 This international standard was developed in accordance with internationally recognized principles on standardization
established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued
by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
2. Referenced documents
2.1 ASTM Standards:
E170 Terminology Relating to Radiation Measurements and Dosimetry
This practice is under the jurisdiction of ASTM Committee E61 on Radiation Processing and is the direct responsibility of Subcommittee E61.04 on Specialty Application,
and is also under the jurisdiction of ISO/TC 85/WG 3.
Current edition approved Jan. 16, 2017. Published February 2017.June 1, 2022. Published September 2022. Originally published as ASTM E 1939–98. Last previous
ASTM edition E 1939–98. The present International Standard ISO/ASTM 51939:2017(E)51939:2017(2022)(E) is a revisionreapproval of the last previous edition ISO/ASTM
51939:05(2013)(E).51939:2017(E).
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 2022 – All rights reserved
ISO/ASTM 51939:2017 (2022)(E)
2.2 ISO/ASTM Standards:
51026 Practice for Using the Fricke Dosimetry System
51261 Practice for Calibration of Routine Dosimetry Systems for Radiation Processing
51275 Practice for Use of a Radiochromic Film Dosimetry System
51310 Practice for Use of a Radiochromic Optical Waveguide Dosimetry System
51539 Guide for the Use of Radiation-Sensitive Indicators
51607 Practice for Use of the Alanine-EPR Dosimetry System
51707 Guide for Estimating Uncertainties in Dosimetry for Radiation Processing
51956 Practice for Use of Thermoluminescence-Dosimetry Systems (TLD Systems) for Radiation Processing
52116 Practice for Dosimetry for a Self-Contained Dry-Storage Gamma-Ray Irradiator
52628 Practice for Dosimetry in Radiation Processing
52701 Guide for Performance Characterization of Dosimeters and Dosimetry Systems for Use in Radiation Processing
2.3 International Commission on Radiation Units and Measurements Reports (ICRU):
ICRU 80 Dosimetry Systems for Use in Radiation Processing
ICRU 85a Fundamental Quantities and Units for Ionizing Radiation
2.4 ISO Standards:
12749-4 Nuclear energy – Vocabulary – Part 4: Dosimetry for radiation processing
2.5 ISO/IEC Standards:
17025 General Requirements for the Competence of Testing and Calibration Laboratories
2.6 Guidelines on Blood Irradiation:
Guidelines on the Use of Irradiated Blood Components (2013), Prepared by the BCSH Blood Transfusion Task Force
Recommendations Regarding License Amendments and Procedures for Gamma Irradiation of Blood Products, (1993) US Food
and Drug Administration
Guidance for Industry, Gamma Irradiation of Blood and Blood Components: A Pilot Program for Licensing (2000) US Food and
Drug Administration
2.7 Joint Committee for Guides in Metrology (JCGM) Reports:
JCGM 100:2008 GUM 1995, with minor corrections, Evaluation of measurement data – Guide to the expression of uncertainty
in measurement
JCGM 200:2012 (JCGM 200:2008 with minor revisions),VIM,revisions), VIM, International vocabulary of metrology – Basis
and general concepts and associated terms
3. Terminology
3.1 Definitions:
3.1.1 absorbed dose (D)—quotient of dɛ¯ by dm, where dɛ¯ is the mean energy imparted by ionizing radiation to matter of mass
dm (see ICRU 85a).
D 5 d¯ε/dm (1)
3.1.1.1 Discussion—
The SI unit of absorbed dose is the gray (Gy), where 1 gray is equivalent to the absorption of 1 joule per kilogram of the specified
material (1 Gy = 1 J/kg).
3.1.2 absorbed-dose rate (D˙)—quotient of dD by dt, where dD is the increment of absorbed dose in the time interval dt, thus
˙
D 5 dD/dt (2)
3.1.2.1 Discussion—
–1
The SI unit is Gy·s . However, the absorbed-dose rate is often specified in terms of its average value over longer time intervals,
–1 –1
for example, in units of Gy·min or Gy·h .
Available from the International Commission on Radiation Units and Measurements, 7910 Woodmont Ave., Suite 800, Bethesda, MD 20814 U.S.A.
Available from International Organization for Standardization (ISO), ISO Central Secretariat, BIBC II, Chemin de Blandonnet 8, CP 401, 1214 Vernier, Geneva,
Switzerland, http://www.iso.org.
Available from the National Blood Transfusion Service, East Anglian Blood Transfusion Centre, Long Road, Cambridge, CB2 2PT United Kingdom.
Available from the Office of Communication, Training and Manufacturers Assistance (HFM-40), 1401 Rockville Pike, Rockville, MD 20852-1488, USA.
Document produced by working Group 1 of the Joint Committee for Guides in Metrology (JCGM WG1). Available free of charage at the BIPM website
(http://www.bipm.org).
Document produced by working Group 2 of the Joint Committee for Guides in Metrology (JCGM WG2). Available free of charge at the BIPM website
(http://www.bipm.org).
© ISO/ASTM International 2022 – All rights reserved
ISO/ASTM 51939:2017 (2022)(E)
3.1.3 absorbed-dose mapping—measurement of absorbed dose within an irradiated product to produce a one, two, or
three-dimensional distribution of absorbed dose, thus rendering a map of absorbed-dose values.
3.1.3.1 Discussion—
For a blood canister, such a dose map is obtained using dosimeters placed at specified locations within the canister.
3.1.4 activity (A) (of an amount of radionuclide in a particular energy state at a given time)—quotient of –dN by dt, where dN
is the mean change in the number of nuclei in that energy state due to spontaneous nuclear transitions in the time interval dt (see
ICRU 85a).
A 52dN/dt (3)
−1
Unit: s
−1
The special name for the unit of activity is the becquerel (Bq). 1 Bq = 1 s .
3.1.4.1 Discussion—
10 −1
(1) The former special unit of activity was the curie (Ci). 1 Ci = 3.7 × 10 s (exactly).
(2) The ‘particular energy state’ is the ground state of the nuclide unless otherwise specified.
(3) The activity of an amount of radionuclide in a particular energy state is equal to the product of the decay constant, λ, for
that state and the number of nuclei in that state (that is, A=Nλ).
3.1.5 approved laboratory—laboratory that is a recognized national metrology institute; or has been formally accredited to
ISO/IEC 17025; or has a quality system consistent with the requirements of ISO/IEC 17025.
3.1.5.1 Discussion—
A recognized national metrology institute or other calibration laboratory accredited to ISO/IEC 17025 should be used in order to
ensure traceability to a national or international standard. A calibration certificate provided by a laboratory not having formal
recognition or accreditation will not necessarily be proof of traceability to a national or international standard.
3.1.6 bremsstrahlung—broad-spectrum electromagnetic radiation emitted when an energetic charged particle is influenced by a
strong electric or magnetic field, such as that in the vicinity of an atomic nucleus.
3.1.6.1 Discussion—
(1) In radiation processing, bremsstrahlung photons with sufficient energy to cause ionization are generated by the deceleration
or deflection of energetic electrons in a target material. When an electron passes close to an atomic nucleus, the strong coulomb
field causes the electron to deviate from its original motion. This interaction results in a loss of kinetic energy by the emission of
electromagnetic radiation. Since such encounters are uncontrolled, they produce a continuous photon energy distribution that
extends up to the maximum kinetic energy of the incident electron.
(2) The bremsstrahlung spectrum depends on the electron energy, the composition and thickness of the target, and the angle
of emission with respect to the incident electron.
3.1.7 calibration—set of operations that establish under specified conditions, the relationship between values of quantities
indicated by a measuring instrument or measuring system, or values represented by a material measure or a reference material, and
the corresponding values realized by standards.
3.1.7.1 Discussion—
Calibration conditions include environmental and irradiation conditions present during irradiation, storage and measurement of the
dosimeters that are used for the generation of a calibration curve.
3.1.8 dosimeter—device that, when irradiated, exhibits a quantifiable change that can be related to absorbed dose in a given
material using appropriate measurement instruments and procedures.
3.1.9 dosimeter batch—quantity of dosimeters made from a specific mass of material with uniform composition, fabricated in a
single production run under controlled, consistent conditions and having a unique identification code.
3.1.10 dosimetry system—system used for measuring absorbed dose, consisting of dosimeters, measurement instruments and their
associated reference standards, and procedures for the system’s use.
3.1.11 installation qualification (IQ)—process of obtaining and documenting evidence that equipment has been provided and
installed in accordance with specifications.
© ISO/ASTM International 2022 – All rights reserved
ISO/ASTM 51939:2017 (2022)(E)
3.1.12 irradiator turntable—device used to rotate the sample during the irradiation process so as to improve dose uniformity.
3.1.12.1 Discussion—
An irradiator turntable is often referred to as a turntable. Some irradiator geometries, for example with a circular array of radiation
sources surrounding the product, may not need a turntable.
3.1.13 isodose curves—lines or surfaces of constant absorbed dose through a specified medium.
3.1.14 measurement management system—set of interrelated or interacting elements necessary to achieve metrological
confirmation and continual control of measurement processes.
3.1.15 operational qualification (OQ)—process of obtaining and documenting evidence that installed equipment operates within
predetermined limits when used in accordance with its operational procedures.
3.1.16 performance qualification (PQ)—process of obtaining and documenting evidence that the equipment as installed and
operated in accordance with operational procedures, consistently performs in accordance with predetermined criteria and thereby
yields product that meeting its specification.
3.1.17 radiation-sensitive indicator—material such as a coated or impregnated adhesive-backed substrate, ink, coating or other
material which may be affixed to or printed on the product and which undergoes a visual change when exposed to ionizing
radiation.
3.1.17.1 Discussion—
Radiation-sensitive indicators are often referred to as “indicators.”
3.1.18 reference-standard dosimetry system—dosimetry system, generally having the highest metrological quality available at a
given location or in a given organization, from which measurements made there are derived.
3.1.19 routine dosimetry system—dosimetry system calibrated against a reference standard dosimetry system and used for routine
absorbed-dose measurements, including dose mapping and process monitoring.
3.1.20 simulated product—material with radiation absorption and scattering properties similar to those of the product, material or
substance to be irradiated.
3.1.20.1 Discussion—
(1) Simulated product is used during irradiator characterization as a substitute for the actual product, material or substance to
be irradiated.
(2) When used in routine production runs in order to compensate for the absence of product, simulated product is sometimes
referred to as compensating dummy.
(3) When used for absorbed-dose mapping, simulated product is sometimes referred to as phantom material.
3.1.21 timer setting—defined time interval during which product is exposed to radiation.
3.1.22 transfer-standard dosimetry system—dosimetry system used as an intermediary to calibrate other dosimetry systems.
3.1.23 transit dose—absorbed dose delivered to a product (or a dosimeter) while it travels between the non-irradiation position
and the irradiation position, or in the case of a movable source while the source moves into and out of its irradiation position.
3.1.24 validation—documented procedure for obtaining, recording and interpreting the results to establish that a proce
...