1.1 本规程概述了辐照器安装鉴定程序和辐照器操作鉴定和性能鉴定期间应遵循的剂量测定程序。还提供了血液制品（血液和血液成分）的常规辐射处理程序。如果遵循这些程序，将有助于确保暴露于伽玛射线或X射线（轫致辐射）的血液产品将接受指定范围的吸收剂量。 1.2 本规程涵盖了自给式辐照器（独立式辐照器）血液制品辐照的剂量测定 放射性核素，如 137 Cs和 60 钴或X射线（轫致辐射）。血液辐照的吸收剂量范围通常为15 Gy至50 Gy。 1.3 用于血液辐照的X射线的光子能量范围通常为40 keV至300 keV。 1.4 本规程还包括使用辐射敏感指示器，以目视和定性指示产品已受到辐射（见ISO/ASTM指南 51539 ). 1.5 本文件是一套标准之一，为辐射处理中正确实施剂量测定提供了建议，并描述了实现符合ISO/ASTM规程要求的方法 52628 用于血液辐照的剂量测定。本标准旨在与ISO/ASTM规程结合阅读 52628 . 1.6 本标准并不旨在解决与其使用相关的所有安全问题（如有）。本标准的使用者有责任在使用前制定适当的安全、健康和环境实践，并确定监管限制的适用性。 1.7 本国际标准是根据世界贸易组织技术性贸易壁垒（TBT）委员会发布的《关于制定国际标准、指南和建议的原则的决定》中确立的国际公认标准化原则制定的。 =====意义和用途====== 4.1 血液和血液成分被照射到预定的吸收剂量，以使活淋巴细胞失活，从而有助于在某些免疫功能低下患者和接受相关供体产品的患者中预防输血诱导的移植物抗宿主病（GVHD） ( 1. , 2. ) . 9 4.2 确保血液和血液成分得到适当辐照对患者健康至关重要。应通过对产品或模拟产品进行准确的吸收剂量测量来证明这一点。 4.3 血液和血液成分通常使用来自 137 Cs或 60 钴源，或X射线装置的X射线。 4.4 血液辐照规范包括吸收剂量的下限，也可能包括上限或中心靶剂量。对于给定的应用，这些值中的任何一个都可以由根据现有科学数据制定的法规规定（参见 2.6 ). 4.5 对于每个血液辐照器，作为辐照器验收测试的一部分，使用参考标准剂量测定系统测量容器内参考位置处的吸收剂量率。该参考标准测量用于确定操作参数，以便向血液和血液成分输送规定剂量。 4.6 吸收剂量测量在血液或血液等效体积内进行，以确定吸收剂量分布。此类测量通常使用模拟产品进行（例如，聚苯乙烯被视为血液等效物 137 Cs光子能量）。 4.7 剂量测定是测量管理系统的一部分，用于确保辐射过程符合预定规范（见ISO/ASTM规程 52628 ). 4.8 血液和血液成分通常在冷冻或冷冻条件下进行辐照。因此，应注意确保剂量计和辐射敏感指示器可以在这种温度条件下使用。 4.9 适当的文件和记录保存是辐射过程的关键组成部分。文件和记录保存要求可以由监管机构规定，也可以在公司的质量政策中给出。 4.10 大多数剂量计的响应在光子能量小于100 keV时具有显著的能量依赖性，因此在测量该能量范围内的吸收剂量时必须谨慎。

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 137 Cs and 60 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. ====== 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 137 Cs or 60 Co 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 137 Cs 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 documentation and record keeping are critical components of a radiation process. Documentation and record keeping requirements may be specified by regulatory authorities or may be given in the corporation’s quality policy. 4.10 Response of most dosimeters has significant energy dependence at photon energies of less than 100 keV, so proper care must be exercised when measuring absorbed dose in that energy range.