ISO 51939:2017

Description

1.1 This practice outlines the irradiator installation qualifi-cation program and the dosimetric procedures to be followed during operational qualification and performance qualification of the irradiator. Procedures for the routine radiation process-ing 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 ISO 51939:2017 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 ISO 51939:2017 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 appro-priate safety and health practices and to determine the applicability or regulatory limitations prior to use.