1.1本规程概述了辐照器的安装鉴定程序，以及在处理具有放射性核素γ源电离辐射的产品的设施中进行操作鉴定、性能鉴定和常规处理时应遵循的剂量学程序，以确保产品在预定的吸收剂量范围内处理。还讨论了可能影响产品吸收剂量的与操作鉴定、性能鉴定和常规处理相关的其他程序。 注1:剂量测定只是全面质量保证计划的一个组成部分，用于遵守辐射处理应用中使用的良好制造规范。 注2-ISO/ASTM实施规程51818和51649描述了用于辐射处理的低能和高能电子束设施的剂量学程序，ISO/ASTM实施规程51608描述了X射线的程序- 用于辐射处理的射线（韧致辐射）设施。 1.2保健品的辐射灭菌见ISO 11137-1。在ISO 11137-1涵盖的领域中，该标准优先。 1.3本文件是一套标准之一，提供了在辐射处理中正确实施和使用剂量测定的建议。本标准旨在结合ASTM规程E2628阅读。 1.4 本标准并非旨在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，并确定监管限制的适用性。 ====意义和用途====== 4.1各种产品和材料在γ辐照设施中以预定剂量进行常规辐照，以减少其微生物数量或改变其特性。 剂量测定要求可能因辐照应用和产品的最终用途而异。可使用剂量测定法的辐照应用示例如下: 4.1.1医疗器械的灭菌， 4.1.2为控制寄生虫和病原体、杀虫和延长保质期而进行的食品处理， 4.1.3消费品的消毒， 4.1.4聚合物和弹性体的交联或降解， 4.1.5单体聚合和单体接枝到聚合物上， 4.1.6宝石和其他材料的颜色增强， 4.1.7半导体器件特性的修改，以及 4.1.8材料效应研究。 注3-规定的辐照过程（如医疗器械的灭菌和食品处理）需要剂量测定。它对于其他工业过程可能不那么重要，例如聚合物改性，可以通过辐照材料的物理和化学性质的变化来评估。 4.2辐照过程通常需要最小吸收剂量才能达到预期效果。也可能存在产品可以耐受且仍符合其功能或监管规范的最大吸收剂量。剂量测定对辐照过程至关重要，因为它用于确定这两个极限，并确认产品在这些极限内常规辐照。 4.3产品内的吸收剂量分布取决于产品的总体尺寸和质量、辐照几何形状和源放射性分布。 4.4在使用辐照设施之前，必须有资格确定其在可重复提供已知可控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，以及表征辐照器在一系列产品密度下所传递的吸收剂量的大小、分布和再现性。 4.5为确保合格工艺中剂量传递的一致性和可再现性，常规工艺控制要求在辐照前后记录产品处理程序、一致的产品装载配置、关键工艺参数的控制和监测、常规产品剂量测定和所需活动的记录。

1.1 This practice outlines the installation qualification program for an irradiator and the dosimetric procedures to be followed during operational qualification, performance qualification, and routine processing in facilities that process products with ionizing radiation from radionuclide gamma sources to ensure that product has been treated within a predetermined range of absorbed dose. 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 51818 and 51649 describe dosimetric procedures for low and high enery electron beam facilities for radiation processing and ISO/ASTM Practice 51608 describes procedures for X-ray (bremsstrahlung) facilities for radiation processing. 1.2 For the radiation sterilization of health care products, see ISO 11137-1. In those areas covered by ISO 11137-1, that standard takes precedence. 1.3 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 ASTM Practice E2628. 1.4 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 Various products and materials routinely are irradiated at predetermined doses in gamma irradiation facilities to reduce their microbial population or to modify their characteristics. Dosimetry requirements may vary depending upon the irradiation application and end use of the product. Some examples of irradiation applications where dosimetry may be used are: 4.1.1 Sterilization of medical devices, 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 Polymerization of monomers and grafting of monomers onto polymers, 4.1.6 Enhancement of color in gemstones and other materials, 4.1.7 Modification of characteristics of semiconductor devices, and 4.1.8 Research on materials effects. NOTE 3—Dosimetry is required for regulated irradiation processes such as sterilization of medical devices and the treatment of food. It may be less important for other industrial processes, for example, polymer modification, which can be evaluated by changes in the physical and chemical properties of the irradiated materials. 4.2 An irradiation process usually requires a minimum absorbed dose to achieve the intended effect. There also may be a maximum absorbed dose that the product can tolerate and still meet its functional or regulatory specifications. Dosimetry is essential to the irradiation 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 The absorbed-dose distribution within the product depends on the overall product dimensions and mass, irradiation geometry, and source activity distribution. 4.4 Before an irradiation facility can be used, it must be qualified 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 and reproducible dose delivery in a qualified process, routine process control requires documented product handling procedures before and after irradiation, consistent product loading configuration, control and monitoring of critical process parameters, routine product dosimetry and documentation of the required activities.