Тезис
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.
Жизненный цикл
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Ранее
ОтозваноISO/ASTM 51939:2013
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Сейчас
ОпубликованоISO/ASTM 51939:2017
Стандарт, который пересматривается каждые 5 лет
Этап: 90.93 (Подтверждено)-
00
Предварительная стадия
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10
Стадия, связанная с внесением предложения
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20
Подготовительная стадия
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30
Стадия, связанная с подготовкой проекта комитета
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40
Стадия, связанная с рассмотрением проекта международного стандарта
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50
Стадия, на которой осуществляется принятие стандарта
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60
Стадия, на которой осуществляется публикация
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90
Стадия пересмотра
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95
Стадия, на которой осуществляется отмена стандарта
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00