1.1 本规程概述了在X射线（轫致辐射）辐照器的安装鉴定、操作鉴定、性能鉴定和常规处理过程中应遵循的剂量学程序。还讨论了可能影响产品吸收剂量的与操作确认、性能确认和常规处理相关的其他程序。 注1: 剂量测定只是遵守辐射处理应用中使用的良好制造规范的总体质量保证计划的一个组成部分。 注2: ISO/ASTM规程 51649 , 51818 和 51702 描述用于辐射处理的电子束和伽马设施的剂量学程序。 1.2 关于保健产品的辐射灭菌，参见ISO 11137-1， 医疗保健产品灭菌——辐射——第1部分:医疗器械灭菌过程的开发、验证和常规控制要求 。在ISO 11137涵盖的区域- 1，该标准优先。 1.3 食品辐照见ISO 14470， 食品辐照——使用电离辐射处理食品的辐照过程的开发、验证和常规控制要求 在ISO 14470涵盖的领域中，该标准优先。 1.4 本文件是为辐射处理中正确实施和利用剂量测定提供建议的一系列标准之一。本规范旨在与ISO/ASTM规程一起阅读 52628 ，“辐射处理剂量测定规程”。 1.5 与单能伽马辐射相比，X射线能谱从低值（约35keV）延伸到入射到X射线靶上的电子的最大能量（参见第节 5. 和 附件A1 ). 1.6 关于X射线应用的有效或监管剂量限值和能量限值的信息不在本规程的范围内。 1.7 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建立适当的安全和健康实践，并确定监管限制的适用性。 =====意义和用途====== 4.1 对各种产品和材料进行X射线照射，以改变其特性，提高经济价值，或减少其微生物数量，以实现健康相关目的。剂量测定要求可能因产品类型和最终用途而异。可以使用剂量测定的辐射应用的一些例子是: 4.1.1 保健品灭菌； 4.1.2 以寄生虫和病原体控制、杀虫和延长保质期为目的的食品处理； 4.1.3 消费品消毒； 4.1.4 聚合物和弹性体的交联或降解； 4.1.5 固化复合材料； 4.1.6 单体和低聚物的聚合以及单体在聚合物上的接枝； 4.1.7 增强宝石和其他材料的颜色； 4.1.8 半导体器件特性的修改；和 4.1.9 材料辐照效应研究。 注3: 规定的辐照过程，如保健产品的灭菌和食品的处理，需要具有测量可追溯性和已知测量不确定度的剂量测定法。剂量测定法对其他工业过程（如聚合物改性）可能不太重要，可以通过辐照材料物理性质的变化来评估。然而，常规剂量测定可用于监测辐射过程的再现性。 4.2 辐射处理规范通常包括一对吸收剂量限值:确保预期有益效果的最小值和产品在满足其功能或监管规范的情况下可耐受的最大值。对于给定的应用，这些值中的一个或两个可由工艺规范或法规规定。 了解辐照材料内的剂量分布对满足这些要求至关重要。剂量测定法对辐射过程至关重要，因为它用于确定这两个限值，并确认产品在这些限值内进行常规辐射。 4.3 必须控制几个关键参数，以获得工艺负荷中可再现的剂量分布。产品内的吸收剂量分布取决于产品的总体尺寸、质量和辐照几何结构。处理速率和剂量分布取决于X射线强度、光子能谱、辐射场的空间分布和传送带速度。 4.4 在使用辐照器之前，它必须经过鉴定（IQ、OQ），以确定其在可重复地输送已知的、可控的吸收剂量方面的有效性。这包括测试工艺设备、校准设备和剂量测定系统，以及在一定范围的产品密度下表征辐照器输送的吸收剂量的大小、分布和再现性。 4.5 为了确保在合格的辐照过程中的剂量输送一致，常规过程控制需要常规产品剂量测定程序和处理前后的产品处理程序、一致的产品装载配置、关键过程参数的控制和监控以及所需活动和功能的文件记录。

1.1 This practice outlines the dosimetric procedures to be followed during installation qualification, operational qualification, performance qualification and routine processing at an X-ray (bremsstrahlung) irradiator. Other procedures related to operational qualification, performance qualification and routine processing that may influence absorbed dose in the product are also discussed. Note 1: Dosimetry is only one component of a total quality assurance program for adherence to good manufacturing practices used in radiation processing applications. Note 2: ISO/ASTM Practices 51649 , 51818 and 51702 describe dosimetric procedures for electron beam and gamma facilities for radiation processing. 1.2 For radiation sterilization of health care products, see ISO 11137-1, Sterilization of health care products – Radiation – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices . In those areas covered by ISO 11137-1, that standard takes precedence. 1.3 For irradiation of food, see ISO 14470, Food irradiation – Requirements for development, validation and routine control of the process of irradiation using ionizing radiation for the treatment of food . In those areas covered by ISO 14470, that standard takes precedence. 1.4 This document is one of a set of standards that provides recommendations for properly implementing and utilizing dosimetry in radiation processing. It is intended to be read in conjunction with ISO/ASTM Practice 52628 , “Practice for Dosimetry in Radiation Processing”. 1.5 In contrast to monoenergetic gamma radiation, the X-ray energy spectrum extends from low values (about 35 keV) up to the maximum energy of the electrons incident on the X-ray target (see Section 5 and Annex A1 ). 1.6 Information about effective or regulatory dose limits and energy limits for X-ray applications is not within the scope of this practice. 1.7 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 determine the applicability of regulatory limitations prior to use. ====== Significance And Use ====== 4.1 A variety of products and materials are irradiated with X-radiation to modify their characteristics and improve the economic value or to reduce their microbial population for health-related purposes. Dosimetry requirements might vary depending on the type and end use of the product. Some examples of irradiation applications where dosimetry may be used are: 4.1.1 Sterilization of health care products; 4.1.2 Treatment of food for the purpose of parasite and pathogen control, insect disinfestation, and shelf life extension; 4.1.3 Disinfection of consumer products; 4.1.4 Cross-linking or degradation of polymers and elastomers; 4.1.5 Curing composite material; 4.1.6 Polymerization of monomers and oligomer and grafting of monomers onto polymers; 4.1.7 Enhancement of color in gemstones and other materials; 4.1.8 Modification of characteristics of semiconductor devices; and 4.1.9 Research on materials effects of irradiation. Note 3: Dosimetry with measurement traceability and with known measurement uncertainty is required for regulated irradiation processes, such as the sterilization of health care products and treatment of food. Dosimetry may be less important for other industrial processes, such as polymer modification, which can be evaluated by changes in the physical properties of the irradiated materials. Nevertheless, routine dosimetry may be used to monitor the reproducibility of the radiation process. 4.2 Radiation processing specifications usually include a pair of absorbed-dose limits: a minimum value to ensure the intended beneficial effect and a maximum value that the product can tolerate while still meeting its functional or regulatory specifications. For a given application, one or both of these values may be prescribed by process specifications or regulations. Knowledge of the dose distribution within irradiated material is essential to help meet these requirements. Dosimetry is essential to the radiation process since it is used to determine both of these limits and to confirm that the product is routinely irradiated within these limits. 4.3 Several critical parameters must be controlled to obtain reproducible dose distributions in the process load. The absorbed-dose distribution within the product depends on the overall product dimensions and mass and irradiation geometry. The processing rate and dose distribution depend on the X-ray intensity, photon energy spectrum, and spatial distribution of the radiation field and conveyor speed. 4.4 Before an irradiator can be used, it must be qualified (IQ, OQ) to determine its effectiveness in reproducibly delivering known, controllable absorbed doses. This involves testing the process equipment, calibrating the equipment and dosimetry system, and characterizing the magnitude, distribution and reproducibility of the absorbed dose delivered by the irradiator for a range of product densities. 4.5 To ensure consistent dose delivery in a qualified irradiation process, routine process control requires procedures for routine product dosimetry and for product handling before and after the treatment, consistent product loading configuration, control and monitoring of critical process parameters, and documentation of the required activities and functions.