ASTM ISO/ASTM51939-17

Standard Practice for Blood Irradiation Dosimetry

SIGNIFICANCE AND USE
4.1 Blood and blood components are irradiated to predetermined absorbed 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).9  
4.2 The assurance that blood and blood components have been properly irradiated is of crucial importance for patient health. This shall be demonstrated by means of accurate absorbed-dose measurements on the product, or in simulated product.  
4.3 Blood and blood components are usually irradiated using gamma radiation from 137Cs or 60Co sources, or X-radiation from X-ray units.  
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 2.6).  
4.5 For each blood irradiator, an absorbed-dose rate at a reference position within the canister is measured as part of irradiator acceptance testing using a reference-standard dosimetry system. That reference-standard measurement is used to establish operating parameters so as to deliver specified dose to blood and blood components.  
4.6 Absorbed-dose measurements are performed within the blood or blood-equivalent volume for determining the absorbed-dose distribution. Such measurements are often performed using simulated product (for example, polystyrene is considered blood equivalent for 137Cs photon energies).  
4.7 Dosimetry is part of a measurement management system that is applied to ensure that the radiation process meets predetermined specifications (see ISO/ASTM Practice 52628).  
4.8 Blood and blood components are usually irradiated in chilled or frozen condition. Care should be taken, therefore, to ensure that the dosimeters and radiation-sensitive indicators can be used under such temperature conditions.  
4.9 Proper ...
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) utilizing radionuclides such as 137Cs and  60Co, 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 and health practices and to determine the applicability or regulatory limitations prior to use.

General Information

• Status: Historical
• Publication Date: 31-Dec-2015
• 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 51939:2017(E)
Standard Practice for
1
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 priate safety and health practices and to determine the
applicability or regulatory limitations prior to use.
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
2.1 ASTM Standards:
of the irradiator. Procedures for the routine radiation process-
E170Terminology Relating to Radiation Measurements and
ing of blood product (blood and blood components) are also
Dosimetry
given.Iffollowed,theseprocedureswillhelpensurethatblood
2
2.2 ISO/ASTM Standards:
product exposed to gamma radiation or X-radiation
51026Practice for Using the Fricke Dosimetry System
(bremsstrahlung) will receive absorbed doses with a specified
51261Practice 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) utilizingradionuclides such as Cs and Co, or
51310Practice 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.
51539Guide for the Use of Radiation-Sensitive Indicators
51607Practice 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.
51707Guide 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
51956Practice 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
52116Practice 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
52628Practice for Dosimetry in Radiation Processing
compliance with the requirements of ISO/ASTM Practice
52701Guide 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-
3
surements Reports (ICRU):
1.6 This standard does not purport to address all of the
safety concerns, if any, associated with its use. It is the ICRU 80Dosimetry Systems for Use in Radiation Process-
ing
responsibility of the user of this standard to establish appro-
ICRU 85aFundamental Quantities and Units for Ionizing
Radiation
1
This practice is under the jurisdiction of ASTM Committee E61 on Radiation
2
Processing and is the direct responsibility of Subcommittee E61.04 on Specialty For referenced ASTM and ISO/ASTM standards, visit the ASTM website,
Application, and is also under the jurisdiction of ISO/TC 85/WG 3. www.astm.org, or contact ASTM Customer Service at [e-mail]. For
Current edition approved Jan. 16, 2017. Published February 2017. Originally Annual Book of ASTM Standards volume information, refer to the standard’s
published as ASTM E 1939–98. Last previous ASTM edition E 1939–98. The Document Summary page on the ASTM website.
3
present International Standard ISO/ASTM 51939:2017(E) is a revision of the last Available from the International Commission on Radiation Units and
previous edition ISO/ASTM 51939:05(2013)(E). Measurements, 7910 Woodmont Ave., Suite 800, Bethesda, MD 20814 U.S.A.
© ISO/ASTM International 2022 – All rights reserved
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ISO/ASTM 51939:2017(E)
4
2.4 ISO Standards: three-dimensionaldistributionofabsorbeddose,thusrendering
12749-4Nuclear energy – Vocabulary – Part 4: Dosimetry a map of absorbed-dose values.
for radiation processing 3.1.3.1 Discussion—Forabloodcanister,suchadosemapis
4
obtained using dosimeters placed at specified locations within
2.5 ISO/IEC Standards:
the canister.
17025General Requirements for the Competence ofTesting
and Calibration Laboratories
3.1.4 activity (A) (of an amount of radionuclide in a
particular energy state at a given time)—quotientof–dNbydt,
2.6 Guidelines on Blood Irradiation:
where dN is the mean change in the number of nuclei in that
Guidel
...

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 51939:2005 (2013)(E)
ISO/ASTM 51939 − 2017(E)
Standard Practice for
1
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, operational qualification, performance qualification, and
routine product processing qualification program and the dosimetric procedures to be followed in the irradiation of blood and blood
components by the blood-banking community. 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 to ensure that the products processed with ionizing radiation from gamma, X-radiation (bremsstrahlung), or
electron sources blood product exposed to gamma radiation or X-radiation (bremsstrahlung) will receive absorbed doses
withinwith a predeterminedspecified range.
1.2 This practice covers dosimetry for the irradiation of blood for these types of irradiators: product for self-contained irradiators
137 60
(free-standing irradiators) utilizing utilizing radionuclides such as Cs, Cs and Co, or X-radiation (bremsstrahlung), tele-
therapy units, and electron accelerators.(bremsstrahlung). 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 photon energy range of X-radiation used for blood irradiation is typically from approximately 40 keV to 5 MeV for
photons, and up to 10 MeV for electrons.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.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 and health practices and to determine the applicability or regulatory
limitations prior to use.
2. Referenced Documentsdocuments
2
2.1 ASTM Standards:
E170 Terminology Relating to Radiation Measurements and Dosimetry
E1026 Practice for Using the Fricke Dosimetry System
E2304 Practice for Use of a LiF Photo-Fluorescent Film Dosimetry System
2
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
51400 Practice for Characterization and Performance of a High-Dose Radiation Dosimetry Calibration Laboratory
51538 Practice for Use of the Ethanol-Chlorobenzene Dosimetry System
51539 Guide for the Use of Radiation-Sensitive Indicators
1
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 May 27, 2013Jan. 16, 2017. Published July 2013.February 2017. Originally published as ASTM E 1939–98. Last previous ASTM edition E
1939–98. The present International Standard ISO/ASTM 51939:2005(2013)(E)51939:2017(E) is a reapprovalrevision of the last previous edition ISO/ASTM
51939:2005(E).51939:05(2013)(E).
2
For referenced ASTM and ISO/ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at [e-mail]. For Annual Book
of ASTM Standards volume information, refer to the standard’s Document Summary page on the ASTM website.
© ISO/ASTM International 2017 – All rights reserved
1

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ISO/ASTM 51939:2017(E)
51607 Practice for Use of the Alanine-EPR Dosimetry System
51608 Practice for Dosimetry in an X-ray (Bremsstrahlung) Facility for Radiation Processing
51707 Guide for Estimating Uncertainties in Dosimetry
...