ASTM ISO/ASTM51939-22
(Practice)Standard Practice for Blood Irradiation Dosimetry
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, health, and environmental practices and determine the applicability of 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 ...
General Information
Relations
Buy Standard
Standards Content (Sample)
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.
Designation: 51939 − 22
Standard Practice for
1
Blood Irradiation Dosimetry
This standard is issued under the fixed designation 51939; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope Development of International Standards, Guides and Recom-
mendations issued by the World Trade Organization Technical
1.1 This practice outlines the irradiator installation qualifi-
Barriers to Trade (TBT) Committee.
cation program and the dosimetric procedures to be followed
during operational qualification and performance qualification
2. Referenced documents
of the irradiator. Procedures for the routine radiation process-
ing of blood product (blood and blood components) are also 2
2.1 ASTM Standards:
given. If followed, these procedures will help ensure that blood
E170 Terminology Relating to Radiation Measurements and
product exposed to gamma radiation or X-radiation
Dosimetry
(bremsstrahlung) will receive absorbed doses with a specified
2
2.2 ISO/ASTM Standards:
range.
51026 Practice for Using the Fricke Dosimetry System
1.2 This practice covers dosimetry for the irradiation of
51261 Practice for Calibration of Routine Dosimetry Sys-
blood product for self-contained irradiators (free-standing
tems for Radiation Processing
137 60
irradiators) utilizing radionuclides such as Cs and Co, or
51275 Practice for Use of a Radiochromic Film Dosimetry
X-radiation (bremsstrahlung). The absorbed dose range for
System
blood irradiation is typically 15 Gy to 50 Gy.
51310 Practice for Use of a Radiochromic Optical Wave-
1.3 The photon energy range of X-radiation used for blood
guide Dosimetry System
irradiation is typically from 40 keV to 300 keV.
51539 Guide for the Use of Radiation-Sensitive Indicators
51607 Practice for Use of the Alanine-EPR Dosimetry Sys-
1.4 This practice also covers the use of radiation-sensitive
tem
indicators for the visual and qualitative indication that the
product has been irradiated (see ISO/ASTM Guide 51539). 51707 Guide for Estimating Uncertainties in Dosimetry for
Radiation Processing
1.5 This document is one of a set of standards that provides
51956 Practice for Use of Thermoluminescence-Dosimetry
recommendations for properly implementing dosimetry in
Systems (TLD Systems) for Radiation Processing
radiation processing and describes a means of achieving
52116 Practice for Dosimetry for a Self-Contained Dry-
compliance with the requirements of ISO/ASTM Practice
Storage Gamma-Ray Irradiator
52628 for dosimetry performed for blood irradiation. It is
52628 Practice for Dosimetry in Radiation Processing
intended to be read in conjunction with ISO/ASTM Practice
52701 Guide for Performance Characterization of Dosim-
52628.
eters and Dosimetry Systems for Use in Radiation Pro-
1.6 This standard does not purport to address all of the
cessing
safety concerns, if any, associated with its use. It is the
2.3 International Commission on Radiation Units and Mea-
responsibility of the user of this standard to establish appro-
3
priate safety, health, and environmental practices and deter- surements Reports (ICRU):
ICRU 80 Dosimetry Systems for Use in Radiation Process-
mine the applicability of regulatory limitations prior to use.
1.7 This international standard was developed in accor- ing
dance with internationally recognized principles on standard- ICRU 85a Fundamental Quantities and Units for Ionizing
ization established in the Decision on Principles for the 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. Originally developed as a joint ASTM/ISO standard in conjunction www.astm.org, or contact ASTM Customer Service at service@astm.org. For
with ISO/TC 85/WG 3. Annual Book of ASTM Standards volume information, refer to the standard’s
Current edition approved Dec. 1, 2022. Published May 2024. Originally Document Summary page on the ASTM website.
3
approved in 1998. Last previous edition approved in 2022 as ISO/ASTM Available from the International Commission on Radiation Units and
51939:2017(2022)(E). DOI: 10.1520/51939-22. Measurements, 7910 Woodmont Ave., Suite 800, Bethesda, MD 20814 U.S.A.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------
...
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.
Designation: ISO/ASTM 51939 − 2017 (Reapproved 2022)(E) 51939 − 22
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. A number in parentheses indicates the year of last
reapproval. A superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
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, health, and environmental practices and determine the applicability of
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
2.1 ASTM Standards:
E170 Terminology Relating to Radiation Measurements and Dosimetry
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 . Originally developed as a joint ASTM/ISO standard in conjunction with ISO/TC 85/WG 3.
Current edition approved Dec. 1, 2022June 1, 2022. . Published May 2024September 2022. Originally published as ASTM E 1939–98. Last previous ASTM edition E
1939–98. The present International Standard ISO/ASTM 51939:2017(2022)(E) is a reapproval of the last previous edition ISO/ASTM 51939:2017(E). Originally approved
in 1998. Last previous edition approved in 2022 as ISO/ASTM 51939:2017(2022)(E). DOI: 10.1520/51939-22.
2
For referenced ASTM and ISO/ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at service@astm.org. For Annual Book
of ASTM Standards volume information, refer to the standard’s Document Summary page on the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
51939 − 22
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
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 Gui
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.