ASTM ISO/ASTM51939-05(2013)

Standard Practice for Blood Irradiation Dosimetry

SIGNIFICANCE AND USE
4.1 The assurance that blood and blood components have been properly irradiated is of crucial importance for patient health. The irradiator operator must demonstrate by means of accurate absorbed-dose measurements on the product, or in simulated product, that the specified absorbed dose has been achieved throughout the product.
4.2 Blood and blood components are irradiated at predetermined doses to inactivate viable lymphocytes to help prevent transfusion-induced graft-versus-host disease (GVHD) in certain immunocompromised patients and those receiving related-donor products (1, 2).6
4.3 Blood and blood components may be treated with ionizing radiation, such as gamma radiation from 137Cs or 60Co sources, and from self-contained X-ray (bremsstrahlung) units and medical linear X-ray (bremsstrahlung) and electron accelerators used primarily for radiotherapy.
4.3.1 The terms “gamma rays” and “gamma radiation” are used interchangeably, as are the terms “X-ray” and “Xradiation.”
4.4 Blood irradiation specifications include a lower limit of absorbed dose, and may include an upper limit or central target dose. For a given application, any of these values may be prescribed by regulations that have been established on the basis of available scientific data. See 2.4.
4.5 For each blood irradiator, an absorbed-dose rate at a reference position within the canister is measured by the manufacturer as part of acceptance testing using a reference-standard dosimetry system. That reference-standard measurement is used to calculate the timer setting required to deliver the specified absorbed dose to the center of the canister with blood and blood components, or other reference position. Either relative or absolute absorbed-dose measurements are performed within the blood- or blood-equivalent volume for determining the absorbed-dose distribution. Accurate radiation dosimetry at a reference position which could be the position of the maximum absorbed dose (Dmax) or minimum absorbed ...
SCOPE
1.1 This practice outlines irradiator installation qualification, operational qualification, performance qualification, and routine product processing dosimetric procedures to be followed in the irradiation of blood and blood components by the blood-banking community. If followed, these procedures will help to ensure that the products processed with ionizing radiation from gamma, X-radiation (bremsstrahlung), or electron sources receive absorbed doses within a predetermined range.
1.2 This practice covers dosimetry for the irradiation of blood for these types of irradiators: self-contained irradiators (free-standing irradiators) utilizing 137Cs, 60Co or X-radiation (bremsstrahlung), teletherapy units, and electron accelerators. The absorbed dose range for blood irradiation is typically 15 Gy to 50 Gy. In some jurisdictions, the absorbed dose range for blood irradiation is 25 Gy to 50 Gy.
1.3 The energy range is typically from approximately 40 keV to 5 MeV for photons, and up to 10 MeV for electrons.
1.4 This practice also covers the use of radiation-sensitive indicators for the visual and qualitative indication that the product has been irradiated.
1.5 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 to determine the applicability or regulatory limitations prior to use.

General Information

• Status: Historical
• Publication Date: 07-Aug-2013
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• ICS: 17.240 - Radiation measurements
• Technical Committee: E61 - Radiation Processing
• Drafting Committee: E61.04 - Specialty Application

Standards Content (Sample)

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 51939:2005 (2013)(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 E2304Practice for Use of a LiF Photo-Fluorescent Film
Dosimetry System
1.1 This practice outlines irradiator installation
2.2 ISO/ASTM Standards:
qualification, operational qualification, performance
51261Practice for Calibration of Routine Dosimetry Sys-
qualification,androutineproductprocessingdosimetricproce-
tems for Radiation Processing
dures to be followed in the irradiation of blood and blood
51275 Practice for Use of a Radiochromic Film Dosimetry
components by the blood-banking community. If followed,
System
theseprocedureswillhelptoensurethattheproductsprocessed
51310Practice for Use of a Radiochromic Optical Wave-
with ionizing radiation from gamma, X-radiation
guide Dosimetry System
(bremsstrahlung), or electron sources receive absorbed doses
51400Practice for Characterization and Performance of a
within a predetermined range.
High-Dose Radiation Dosimetry Calibration Laboratory
1.2 This practice covers dosimetry for the irradiation of
51538Practice for Use of the Ethanol-Chlorobenzene Do-
blood for these types of irradiators: self-contained irradiators
simetry System
137 60
(free-standing irradiators) utilizing Cs, Co or X-radiation
51539Guide for the Use of Radiation-Sensitive Indicators
(bremsstrahlung), teletherapy units, and electron accelerators.
51607Practice for Use of the Alanine-EPR Dosimetry Sys-
The absorbed dose range for blood irradiation is typically 15
tem
Gyto50Gy.Insomejurisdictions,theabsorbeddoserangefor
51608Practice for Dosimetry in an X-ray (Bremsstrahlung)
blood irradiation is 25 Gy to 50 Gy.
Facility for Radiation Processing
1.3 The energy range is typically from approximately 40 51707Guide for Estimating Uncertainties in Dosimetry for
Radiation Processing
keV to 5 MeV for photons, and up to 10 MeV for electrons.
51956PracticeforThermoluminescentDosimetry(TLD)for
1.4 This practice also covers the use of radiation-sensitive
Radiation Processing
indicators for the visual and qualitative indication that the
52116Practice for Dosimetry for a Self-Contained Dry-
product has been irradiated.
Storage Gamma-Ray Irradiator
1.5 This standard does not purport to address all of the
2.3 International Commission on Radiation Units and Mea-
safety concerns, if any, associated with its use. It is the 3
surements Reports (ICRU):
responsibility of the user of this standard to establish appro-
ICRU 85Fundamental Quantities and Units for Ionizing
priate safety and health practices and to determine the
Radiation
applicability or regulatory limitations prior to use.
2.4 Guidelines on Blood Irradiation:
Guidelines on Gamma Irradiation of Blood Components for
2. Referenced Documents
the Prevention of Transfusion-associated Graft-versus-
2.1 ASTM Standards:
host Disease, Prepared by the BCSH Blood Transfusion
E170Terminology Relating to Radiation Measurements and
Task Force
Dosimetry
Recommendations Regarding License Amendments and
E1026Practice for Using the Fricke Dosimetry System
Procedures for Gamma Irradiation of Blood Products,
(1993)US Food and Drug Administration
Guidance for Industry,Gamma Irradiation of Blood and
This practice is under the jurisdiction of ASTM Committee E61 on Radiation
BloodComponents:APilotProgramforLicensing(2000)
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. US Food and Drug Administration
Current edition approved May 27, 2013. Published July 2013. Originally
published as ASTM E 1939–98. Last previous ASTM edition E 1939–98. The
present International Standard ISO/ASTM 51939:2005(2013)(E) is a reapproval of Available from the International Commission on Radiation Units and
the last previous edition ISO/ASTM 51939:2005(E). Measurements, 7910 Woodmont Ave., Suite 800, Bethesda, MD 20814 U.S.A.
2 4
For referenced ASTM and ISO/ASTM standards, visit the ASTM website, Available from the National Blood Transfusion Service, East Anglian Blood
www.astm.org, or contact ASTM Customer Service at [e-mail]. For Transfusion Centre, Long Road, Cambridge, CB2 2PT United Kingdom.
Annual Book of ASTM Standards volume information, refer to the standard’s Available from the Office of Communication, Training and Manufacturers
Document Summary page on the ASTM website. Assistance (HFM-40), 1401 Rockville Pike, Rockville, MD 20852-1488, USA.
© ISO/ASTM International 2017 – All rights reserved
ISO/ASTM 51939:2005 (2013)(E)
3. Terminology be related to absorbed dose in a given material using appro-
priate analytical instrumentation and techniques.
3.1 Definitions:
3.1.9.1 Discussion—Adosimetermustexhibitthereproduc-
3.1.1 absorbed dose (D)—quantity of ionizing radiation
ible and quantifiable properties that allow it to be calibrated
energy imparted per unit mass of a specified material. The SI
and compared to national standards.
unit of absorbed dose is the gray (Gy), where 1 gray is
equivalent to the absorption of 1 joule per kilogram of the
3.1.10 dosimeter batch—quantity of dosimeters made from
specified material (1 Gy = 1 J/kg). The mathematical relation-
a specific mass of material with uniform composition, fabri-
ship is the quotient of dε¯ by dm, where dε¯ is the mean
cated in a single production run under controlled, consistent
incremental energy imparted by ionizing radiation to matter of
conditions and having a unique identification code.
incremental mass dm (see ICRU 85).
3.1.11 dosimetry system—system used for determining ab-
D 5dε¯/dm (1)
sorbed dose, consisting of dosimeters, measurement instru-
3.1.1.1 Discussion—The discontinued unit for absorbed
ments and their associated reference standards, and procedures
dose is the rad (1 rad = 100 erg/g = 0.01 Gy). Absorbed dose
for the system’s use.
is sometimes referred to simply as dose.
3.1.12 installation qualification (IQ)—obtaining and docu-
˙
3.1.2 absorbed-dose rate (D)—absorbed dose in a material
menting evidence that the irradiator, with all its associated
per incremental time interval, that is, the quotient of dD by dt.
equipment and instrumentation, has been provided and in-
˙
stalled in accordance with specifications.
D 5 dD/dt (2)
–1
3.1.13 instrument traceability—abilitytodemonstratethata
Unit: Gy·s .
measurementinstrumenthasbeencalibratedatacceptabletime
3.1.3 absorbed-dose mapping—measurement of absorbed
intervals against a national or international standard or against
dose within product using dosimeters placed at specified
asecondarystandardthathasbeencalibratedagainstanational
locations to produce a one, two, or three-dimensional distribu-
or international standard.
tion of absorbed dose, thus rendering a map of absorbed-dose
3.1.14 irradiator sample chamber—accessible enclosed
values.
volume in which a sample or sample holder may be placed in
3.1.4 activity (A) (of an amount of radioactive nuclide in a
the loading/unloading position of the irradiator (typically a
particular energy state at a given time)—quotient of dN by dt,
gamma cell) prior to irradiation, and which can be transported
where dN is the expectation value of the number of spontane-
by the sample positioning system to the irradiation position.
ous nuclear transitions from that energy state in the time
interval dt (see ICRU 85).
3.1.15 irradiator turntable—device used to rotate the irra-
diated sample during the irradiation process so as to improve
A 5dN/dt (3)
dose uniformity ratio.
−1
Unit: s
3.1.15.1 Discussion—An irradiator turntable is often re-
The special name for the unit of activity is the becquerel
ferred to as a turntable. Some irradiator geometries, for
−1
(Bq). 1 Bq=1s .
example with a circular array of radiation sources surrounding
3.1.4.1 Discussion—The former special unit of activity was
the product, may not need a turntable.
10 −1
the curie (Ci). 1 Ci = 3.7 × 10 s (exactly).
3.1.16 isodose curve—linesorsurfacesofconstantabsorbed
3.1.5 blood and blood components—include whole blood,
dose through a specified medium.
redcells,frozencells,plateletconcentrates,apheresisplatelets,
3.1.17 measurement quality assurance plan—documented
granulocyte concentrates, and fresh or frozen plasma.
program for the measurement process that ensures on a
3.1.5.1 Discussion—Enclosure systems for blood and blood
continuing basis that the overall uncertainty meets the require-
components are commonly referred to as “bags.” The volume
mentsofthespecificapplication.Thisplanrequirestraceability
of a typical blood bag is less than 0.5 L. Blood and blood
to, and consistency with, nationally or internationally recog-
components are often referred to as blood product.
nized standards.
3.1.6 calibration—set of operations under specified
conditions, which establishes the relationship between values 3.1.18 measurement traceability—ability to demonstrate by
indicated by a measuring instrument or measuring system, and
means of an unbroken chain of comparisons that a measure-
the corresponding values realised by standards traceable to a ment is in agreement within acceptable limits of uncertainty
nationally or internationally recognized laboratory.
with comparable nationally or internationally recognized stan-
dards.
3.1.7 canister—container, usually an aluminum or steel
cylinder, used to house the blood product, or blood-equivalent
3.1.19 operational qualification (OQ)—obtaininganddocu-
product during the irradiation process.
mentingevidencethatinstalledequipmentandinstrumentation
operate within predetermined limits when used in accordance
3.1.8 dose uniformity ratio—ratioofmaximumtominimum
with its operational procedures.
absorbed dose within the irradiated blood or blood product.
This concept is also referred to as the “max/min ratio.”
3.1.20 performance qualification (PQ)—obtaining and
3.1.9 dosimeter—device that, when irradiated, exhibits a documentingevidencethattheequipmentandinstrumentation,
quantifiable change in some property of the device which can as installed and operated in accordance with operational
© ISO/ASTM International 2017 – All rights reserved
ISO/ASTM 51939:2005 (2013)(E)
procedures, consistently perform according to predetermined 3.2 Definitions of other terms used in this standard that
criteria and thereby yield product that meets specifications. pertain to radiation measurement and dosimetry may be found
in ASTM Terminology E170. Definitions in ASTM Terminol-
3.1.21 radiation-sensitive indicator—material such as a
ogy E170 are compatible with ICRU 85; that document,
coated or impregnated adhesive-backed substrate, ink, coating
therefore, may be used as an alternative reference.
or other material which may be affixed to or printed on the
productandwhichundergoesavisualchangewhenexposedto
4. Significance and use
ionizing radiation.
4.1 The assurance that blood and blood components have
3.1.21.1 Discussion—Radiation-sensitive indicators are of-
been properly irradiated is of crucial importance for patient
ten referred to as “indicators.” Radiation-sensitive indicators
health. The irradiator operator must demonstrate by means of
cannot be classified as a “label” under the U.S. FDA “Guide-
accurate absorbed-dose measurements on the product, or in
lines for the Uniform Labeling of Blood and Blood Products”
simulated product, that the specified absorbed dose has been
(August, 1985). Indicators may be used to show that products
achieved throughout the product.
have been exposed to ionizing radiation. They can be used to
provide a visual and qualitative indication of radiation expo-
4.2 Blood and blood components are irradiated at pre-
sure and can be used to distinguish between irradiated blood
determined doses to inactivate viable lymphocytes to help
and blood components and non-irradiated blood and blood
preventtransfusion-inducedgraft-versus-hostdisease(GVHD)
components. Indicators cannot be used as a substitute for
in certain immunocompromised patients and those receiving
proper dosimetry.
related-donor products (1, 2).
3.1.22 reference-standard dosimeter—dosimeter of high
4.3 Blood and blood components may be treated with
metrological quality used as a standard to provide measure- 137 60
ionizingradiation,suchasgammaradiationfrom Csor Co
ments traceable to measurements made with primary-standard
sources, and from self-contained X-ray (bremsstrahlung) units
dosimeters.
and medical linear X-ray (bremsstrahlung) and electron accel-
3.1.23 routine dosimeter—dosimeter calibrated against a
erators used primarily for radiotherapy.
primary-, reference-, or transfer-standard dosimeter and used
4.3.1 The terms “gamma rays” and “gamma radiation” are
for routine absorbed-dose measurement.
used interchangeably, as are the terms “X-ray” and “X-
radiation.”
3.1.24 simulated product—material with radiation attenua-
tion and scattering properties similar to those of the product,
4.4 Blood irradiation specifications include a lower limit of
material or substance to be irradiated.
absorbeddose,andmayincludeanupperlimitorcentraltarget
3.1.24.1 Discussion—Simulatedproductisusedduringirra-
dose. For a given application, any of these values may be
diator characterization as a substitute for the actual product,
prescribed by regulations that have been established on the
materialorsubstancetobeirradiated.Whenusedforabsorbed-
basis of available scientific data. See 2.4.
dose mapping, simulated product is sometimes referred to as
4.5 For each blood irradiator, an absorbed-dose rate at a
phantom material.
reference position within the canister is measured by the
3.1.25 transfer-standard dosimeter—dosimeter, often a
manufacturer as part of acceptance testing using a reference-
reference-standard dosimeter, suitable for transport between
standard dosimetry system. That reference-standard measure-
different locations, used to compare absorbed-dose measure-
ment is used to calculate the timer setting required to deliver
ments.
the specified absorbed dose to the center of the canister with
3.1.26 transit dose—absorbed dose delivered to a product
blood and blood components, or other reference position.
(or a dosimeter) while it travels between the non-irradiation
Either relative or absolute absorbed-dose measurements are
position and the irradiation position, or in the case of a
performed within the blood- or blood-equivalent volume for
movable source while the source moves into and out of its
determining the absorbed-dose distribution.Accurate radiation
irradiation position.
dosimetryatareferencepositionwhichcou
...