1.1本实施规程概述了辐照器的安装鉴定程序以及在使用高能电子和X射线（韧致辐射）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测定程序，以确保产品在预定的吸收剂量范围内进行处理。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有关的其他程序。 有关食品的有效或监管剂量限制，以及直接使用或产生X射线的电子束的适当能量限制的信息不在本规程的范围内（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。 注释2 ISO/ASTM实施规程51204描述了食品加工用γ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。关于电子和X射线辐射剂量测定的讨论，另见ICRU报告35和14。有关脉冲辐射的辐射剂量测定的讨论，请参阅ICRU报告34。 1.3虽然放射性核素的γ辐射具有离散能量，但来自机器源的X射线（韧致辐射）涵盖了广泛的能量范围，从低值（约35 keV）到入射电子束的能量。有关电子束辐照技术和剂量测定的信息，请参阅ISO/ASTM规程51649。有关X射线辐照技术和剂量测定的信息，请参阅ISO/ASTM规程51608。 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食品可使用加速器产生的辐射（电子和X射线）进行处理，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: 可以设定最低限度以确保达到预期的有益效果，也可以设定最高限度以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制内始终如一地提供吸收剂量的能力。 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. 4.2有关各种食品辐射加工的更详细讨论，请参阅指南F 1355、F 1356、F 1736和F 1885以及参考文献（2- 15). 4.3加速器产生的辐射可以是电子或电子产生的X射线。辐射穿透产品以达到预期效果是影响决定使用电子或X射线的因素之一。 4.4为确保产品在规定剂量范围内辐照，常规过程控制需要常规产品剂量测定、记录的产品处理程序（辐照前、辐照中和辐照后）、辐照期间产品的一致方向、关键操作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 high-energy electrons and X-rays (bremsstrahlung) 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, and appropriate energy limits for electron beams used directly or to generate X-rays 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 51204 describes dosimetric procedures for gamma 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 electrons and X-rays also see ICRU Reports 35 and 14. For discussion of radiation dosimetry for pulsed radiation, see ICRU Report 34. 1.3 While gamma radiation from radioactive nuclides has discrete energies, X-rays (bremsstrahlung) from machine sources cover a wide range of energies, from low values (about 35 keV) to the energy of the incident electron beam. For information concerning electron beam irradiation technology and dosimetry, see ISO/ASTM Practice 51649. For information concerning X-ray irradiation technology and dosimetry, see ISO/ASTM Practice 51608. 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 acceleratorgenerated radiation (electrons and X-rays) 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 a maximum limit of absorbed dose, sometimes both: a minimum limit may be set to ensure that the intended beneficial effect is achieved and a maximum limit may be 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 consistently 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 4.2 For more detailed discussions of radiation processing of various foods, see Guides F 1355, F 1356, F 1736, and F 1885 and Refs (2-15). 4.3 Accelerator-generated radiation can be in the form of electrons or X-rays produced by the electrons. Penetration of radiation into the product required to accomplish the intended effect is one of the factors affecting the decision to use electrons or X-rays. 4.4 To ensure that products are irradiated within a specified dose range, routine process control requires routine product dosimetry, documented product handling procedures (before, during and after the irradiation), consistent orientation of the products during irradiation, monitoring of critical operating parameters, and documentation of all relevant activities and functions .