ASTM-ISO/ASTM51939:2013 Edition

ASTM ISO/ASTM51939

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.

Keywords

absorbed dose; absorbed-dose mapping; blood and blood products; blood irradiation; dosimeter; dosimetry system; irradiator; ionizing radiation; measurement quality assurance plan; measurement uncertainty; radiation-sensitive indicators; reference-standard dosimeter; routine dosimeter; transfer-standard dosimeter; ICS 17.240

ICS Code

ICS Number Code 11.040.20 (Transfusion, Infusion)

DOI: 10.1520/ISOASTM51939-05R13