1.1本规程概述了辐照器的安装鉴定程序，以及在使用放射性核素γ源电离辐射加工食品的设施中进行操作鉴定、性能鉴定和常规加工时应遵循的剂量学程序，以确保产品在预定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。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指南F 1355、F 1356、F 1736和F 1885）。 注1:剂量测定只是全面质量保证计划的一个组成部分，以遵守安全卫生食品生产中使用的良好生产规范。 注2-ISO/ASTM规程51431描述了食品加工用电子束和X射线（韧致辐射）辐照设施的剂量学程序。 1.2有关剂量测定系统的选择和校准以及产品中测量吸收剂量的解释，请参阅ISO/ASTM指南51261和ASTM实施规程E 666。有关特定剂量测定系统的使用，请参阅ASTM规程E 1026和E 2304，以及ISO/ASTM规程51205、51275、51276、51310、51401、51538、51540、51607、51650和51956。γ射线辐射剂量测定的讨论- 射线和X射线也见ICRU报告14。 1.3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，并确定监管限制的适用性。 ====意义和用途====== 4.1食品可以用电离辐射处理，例如来自 60 Co或 137 Cs来源，用于多种目的，包括控制寄生虫和病原微生物、杀虫、抑制生长和成熟以及延长保质期。食品辐照规范几乎总是包括吸收剂量的最小或最大限制，有时两者都包括: 设定最低限度是为了确保达到预期的有益效果，设定最高限度是为了避免产品或包装降解。对于给定的应用，根据科学数据制定的政府法规可能会规定其中一个或两个值。因此，在辐照食品之前，有必要确定辐照设施在任何规定限值内传递吸收剂量的能力。此外，有必要在每次生产运行期间监测和记录吸收剂量，以在预定置信水平下验证是否符合工艺规范。 注3:食品法典委员会制定了一项国际通用标准和实施规程，解决了电离辐射在食品处理中的应用问题，并大力强调了剂量测定在确保正确进行辐照方面的作用（1）。 4.2一些食品是在冷冻或冷冻状态下加工的。因此，应根据其在这些条件下的功能选择用于常规处理的剂量计。此外，辐射期间剂量计的温度应足够稳定，以允许校正温度对剂量计响应的影响。为了避免温度梯度对剂量计响应的影响以及随后需要纠正这些影响，可以采用将剂量计与温度梯度隔离的方法。 注4:有关各种食品辐射加工的更详细讨论，请参阅ASTM指南F 1355、F 1356、F 1736和F 1885以及参考文献（1-11）。 4.3确保产品在规定的吸收剂量内辐照- 剂量范围、常规过程控制要求常规产品剂量测定、记录的产品处理程序（辐照之前、期间和之后）、辐照期间产品的一致方向、关键过程参数的监测以及所有相关活动和功能的记录。

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 food 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. Information about effective or regulatory dose limits for food products is not within the scope of this practice (see ASTM Guides F 1355, F 1356, F 1736, and F 1885). Note 1—Dosimetry is only one component of a total quality assurance program for adherence to good manufacturing practices used in the production of safe and wholesome food. Note 2—ISO/ASTM Practice 51431 describes dosimetric procedures for electron beam and X-ray (bremsstrahlung) irradiation facilities for food processing. 1.2 For guidance in the selection and calibration of dosimetry systems, and interpretation of measured absorbed dose in the product, see ISO/ASTM Guide 51261 and ASTM Practice E 666. For the use of specific dosimetry systems, see ASTM Practices E 1026 and E 2304, and ISO/ASTM Practices 51205, 51275, 51276, 51310, 51401, 51538, 51540, 51607, 51650, and 51956. For discussion of radiation dosimetry for gamma-rays and X-rays also see ICRU Report 14. 1.3 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 Food products may be treated with ionizing radiation, such as gamma-rays from 60 Co or 137 Cs sources, for numerous purposes, including control of parasites and pathogenic microorganisms, insect disinfestation, growth and maturation inhibition, and shelf-life extension. Food irradiation specifications almost always include a minimum or maximum limit of absorbed dose, sometimes both: a minimum limit is set to ensure that the intended beneficial effect is achieved and a maximum limit is set for the purpose of avoiding product or packaging degradation. For a given application, one or both of these values may be prescribed by government regulations that have been established on the basis of scientific data. Therefore, prior to the irradiation of the food product, it is necessary to determine the capability of an irradiation facility to deliver the absorbed dose within any prescribed limits. Also, it is necessary to monitor and document the absorbed dose during each production run to verify compliance with the process specifications at a predetermined level of confidence. NOTE 3 - The Codex Alimentarius Commission has developed an international General Standard and a Code of Practice that address the application of ionizing radiation to the treatment of foods and that strongly emphasize the role of dosimetry for ensuring that irradiation will be properly performed (1). 4.2 Some food products are processed in the chilled or frozen state. Therefore, dosimeters used for routine processing should be selected for their functionality under those conditions. Moreover, the temperature of a dosimeter during irradiation should be sufficiently stable to allow correction for temperature effects on the dosimeter response. To avoid the influence of temperature gradients on dosimeter response and the subsequent need to correct for these effects, methods that isolate the dosimeter from temperature gradients may be employed. NOTE 4 - For more detailed discussions of radiation processing of various foods, see ASTM Guides F 1355, F 1356, F 1736, and F 1885 and Refs (1-11). 4.3 To ensure that products are irradiated within a specified absorbed-dose range, routine process control requires routine product dosimetry, documented product handling procedures (before, during, and after irradiation), consistent orientation of the products during irradiation, monitoring of critical process parameters, and documentation of all relevant activities and functions.