1.1本规程概述了血库社区在辐照血液和血液成分时应遵循的辐照器安装鉴定、操作鉴定、性能鉴定和常规产品处理剂量学程序。如果遵循这些程序，将有助于确保使用γ、X射线（韧致辐射）或电子源电离辐射处理的产品在预定范围内收到吸收剂量。1.2本规程涵盖了这些类型辐照器的血液辐照剂量测定:利用137Cs、60Co或X射线（韧致辐射）的独立式辐照器（独立式辐照器）、远程治疗装置和电子加速器。血液辐照的吸收剂量范围通常为15 Gy至50 Gy。在某些管辖区，血液辐照的吸收剂量范围为25 Gy至50 Gy。 1.3光子的能量范围通常约为40 keV至5 MeV，电子的能量范围高达10 MeV。1.4本规程还包括使用辐射敏感指示器对产品进行视觉和定性指示。1.5本标准无意解决与其使用相关的所有安全问题（如有）。本标准的用户有责任在使用前制定适当的安全和健康实践，并确定适用性或监管限制。 ====意义和用途====== 4.1确保血液和血液成分已正确辐照对患者健康至关重要。辐照器操作员必须通过对产品或模拟产品进行准确的吸收剂量测量，证明整个产品已达到规定的吸收剂量。 4.2以预定剂量照射血液和血液成分，使活淋巴细胞失活，以帮助预防某些免疫功能低下患者和接受相关供体产品的患者发生输血诱导的移植物抗宿主病（GVHD）（1，2）。6. 4.3血液和血液成分可以用电离辐射处理，例如来自 137 Cs或 60 Co源，以及自包含式X射线（韧致辐射）装置和主要用于放射治疗的医用线性X射线（韧致辐射）和电子加速器。 4.3.1术语“伽马射线”和“伽马辐射”可互换使用，术语“X射线”和“X辐射”也可互换使用 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目标剂量。对于给定的应用，这些值中的任何一个都可以由基于可用科学数据制定的法规规定。 见2.4。 4.5对于每个血液辐照器，制造商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，作为验收测试的一部分。该参考标准测量值用于计算将指定吸收剂量输送到装有血液和血液成分的容器中心或其他参考位置所需的计时器设置。在血液或血液当量体积内进行相对或绝对吸收剂量测量，以确定吸收剂量分布。参考位置处的精确辐射剂量测定可以是最大吸收剂量（Dmax）或最小吸收剂量（Dmin）的位置，提供了一种定量、独立的方法来监测辐射过程。 4.6剂量测定是测量质量保证计划的一部分，用于确保辐射过程符合预定规范（3）。 4.7通常使用模拟产品进行吸收剂量映射（例如，聚苯乙烯被视为 137 Cs光子能量）。 4.8血液和血液成分通常冷却或冷冻。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处理的关键组成部分。由于相关管理机构制定了最低要求，因此本标准未解决此问题。 4.10大多数剂量计在光子和电子能量低于100 keV时具有显著的能量依赖性，因此在该能量范围内测量吸收剂量时必须非常小心。

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-rays (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-rays (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. ====== Significance And Use ====== 4.1 The assurance that blood and blood components have been properly irradiated is of crucial importance for patient health. The irradiator operator must demonstrate by means of accurate absorbed-dose measurements on the product, or in simulated product, that the specified absorbed dose has been achieved throughout the product. 4.2 Blood and blood components are irradiated at predetermined 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).6 4.3 Blood and blood components may be treated with ionizing radiation, such as gamma rays from 137 Cs or 60 Co sources, and from self-contained X-ray (bremsstrahlung) units and medical linear X-ray (bremsstrahlung) and electron accelerators used primarily for radiotherapy. 4.3.1 The terms "gamma rays" and "gamma radiation" are used interchangeably, as are the terms "X-ray" and "Xradiation." 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 2.4. 4.5 For each blood irradiator, an absorbed-dose rate at a reference position within the canister is measured by the manufacturer as part of acceptance testing using a referencestandard dosimetry system. That reference-standard measurement is used to calculate the timer setting required to deliver the specified absorbed dose to the center of the canister with blood and blood components, or other reference position. Either relative or absolute absorbed-dose measurements are performed within the blood- or blood-equivalent volume for determining the absorbed-dose distribution. Accurate radiation dosimetry at a reference position which could be the position of the maximum absorbed dose (Dmax) or minimum absorbed dose (Dmin) offers a quantitative, independent method to monitor the radiation process. 4.6 Dosimetry is part of a measurement quality assurance program that is applied to ensure that the radiation process meets predetermined specifications (3). 4.7 Absorbed-dose mapping is often performed using simulated product (for example, polystyrene is considered blood equivalent for 137 Cs photon energies). 4.8 Blood and blood components are usually chilled or frozen. 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 radiation processing. This standard does not address this issue since the pertinent governing bodies set minimum requirements. 4.10 Most dosimeters have significant energy dependence at photon and electron energies less than 100 keV, so great care must be exercised when measuring absorbed dose in that energy range.