1.1 本规程涵盖了在电子束设施的安装鉴定、操作鉴定和性能鉴定（IQ、OQ、PQ）以及常规处理中应遵循的剂量学程序，以确保产品已在可接受的吸收剂量范围内处理。还讨论了与IQ、OQ、PQ和常规产品处理相关的其他程序，这些程序可能会影响产品中的吸收剂量。 1.2 本实践中涵盖的电子束能量范围在80到300 keV之间，通常称为低能。 1.3 剂量测定只是辐照设施全面质量保证计划的一个组成部分。特定应用可能需要其他措施，如医疗器械灭菌和食品保存。 1.4 其他特定的ISO和ASTM标准适用于食品辐照和医疗保健产品的辐射灭菌。 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。食品辐照见ISO 14470。有关食品有效或监管剂量限制的信息不在本规程范围内（见ASTM） F1355 和 F1356 ). 1.5 本文件是一套标准之一，为在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要求的方法 52628 . 本标准旨在与ISO/ASTM一起阅读 52628 . 1.6 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、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 各种辐照工艺使用低能电子束设备来改变产品特性。剂量测定要求、测量次数和频率以及记录保存要求将因所加工产品的类型和最终用途而异。剂量学通常与产品的物理、化学或生物测试结合使用，以帮助验证特定的治疗参数。 注2: 在许多情况下，剂量测定结果可能与其他定量产品特性有关； 例如，凝胶分数、熔体流动、弹性模量、分子量分布或固化程度。 4.2 辐射处理规范通常包括最小或最大吸收剂量限制，或两者兼有。对于给定的应用，这些限制可以由政府法规或产品本身固有的限制设定。 4.3 必须控制关键操作参数，以在加工材料中获得可再现的剂量分布。电子束能量、束流、束宽和处理线速度（传输速度）影响吸收剂量。 4.4 在常规使用任何电子束设备之前，必须对其进行表征，以确定剂量与产品和主要操作参数之间的关系。这包括测试工艺设备、校准测量仪器和剂量测定系统，并证明能够在预定规格内始终如一地提供所需剂量。 4.5 为了建立剂量学系统的计量溯源性，并以已知的不确定度测量剂量，有必要在与常规使用中遇到的辐照条件一致的辐照条件下校准剂量学系统。例如，当剂量测定系统用于低能电子束设施时，使用穿透γ辐射或高能电子进行的剂量测定系统校准可能会导致显著的剂量测量误差。第节讨论了校准的细节 5. .

1.1 This practice covers dosimetric procedures to be followed in installation qualification, operational qualification and performance qualification (IQ, OQ, PQ), and routine processing at electron beam facilities to ensure that the product has been treated with an acceptable range of absorbed doses. Other procedures related to IQ, OQ, PQ, and routine product processing that may influence absorbed dose in the product are also discussed. 1.2 The electron beam energy range covered in this practice is between 80 and 300 keV, generally referred to as low energy. 1.3 Dosimetry is only one component of a total quality assurance program for an irradiation facility. Other measures may be required for specific applications such as medical device sterilization and food preservation. 1.4 Other specific ISO and ASTM standards exist for the irradiation of food and the radiation sterilization of health care products. For the radiation sterilization of health care products, see ISO 11137-1. In those areas covered by ISO 11137-1, that standard takes precedence. For food irradiation, see ISO 14470. Information about effective or regulatory dose limits for food products is not within the scope of this practice (see ASTM F1355 and F1356 ). 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 52628 . It is intended to be read in conjunction with ISO/ASTM 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 A variety of irradiation processes use low energy electron beam facilities to modify product characteristics. Dosimetry requirements, the number and frequency of measurements, and record keeping requirements will vary depending on the type and end use of the products being processed. Dosimetry is often used in conjunction with physical, chemical, or biological testing of the product, to help verify specific treatment parameters. Note 2: In many cases dosimetry results can be related to other quantitative product properties; for example, gel fraction, melt flow, elastic modulus, molecular weight distribution, or degree of cure. 4.2 Radiation processing specifications usually include a minimum or maximum absorbed dose limit, or both. For a given application these limits may be set by government regulation or by limits inherent to the product itself. 4.3 Critical operating parameters must be controlled to obtain reproducible dose distribution in processed materials. The electron beam energy, beam current, beam width and process line speed (conveying speed) affect absorbed dose. 4.4 Before any electron beam facility can be routinely utilized, it must be characterized to determine the relationship between dose to product and the main operating parameters. This involves testing of the process equipment, calibrating the measuring instruments and the dosimetry system, and demonstrating the ability to consistently deliver the required dose within predetermined specifications. 4.5 In order to establish metrological traceability for a dosimetry system and to measure doses with a known level of uncertainty, it is necessary to calibrate the dosimetry system under irradiation conditions that are consistent with those encountered in routine use. For example, a dosimetry system calibration conducted using penetrating gamma radiation or high energy electrons may result in significant dose measurement errors when the dosimetry system is used at low energy electron beam facilities. Details of calibration are discussed in Section 5 .