Reaffirmed 2023

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) 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.

2. REFERENCES

2.1 ASTM Standards:

E170 Terminology Relating to Radiation Measurements and Dosimetry

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 Administration6

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, International vocabulary of metrology – Basis and general concepts and associated terms