1.1 本文件提供了操作资格（OQ）测试指南，以满足ISO 11137-1、ISO 14470、ISO/ASTM中定义的操作资格要求 51702 和ISO/ASTM 52303 对于γ辐照器。 1.1.1 讨论了OQ测试的类型，以帮助用户更好地了解其辐射器的操作方面，并确定哪些OQ测试适合评估辐射器的变化。 1.1.2 工厂应评估所选运行确认测试和被认为不必要的测试的理由。 1.2 OQ的具体要求取决于辐照工艺的应用，不在本指南的范围内。例如，在对医疗保健产品进行消毒时，OQ的要求可以在ISO 11137中找到- 1. 1.3 辐照器的变更是变更控制过程的一个组成部分。辐照器变更后的运行确认测试作为变更控制文件的一部分确定，并应包括支持需要完成哪些测试的决策的理由。 1.4 对于辐照器更换后的OQ研究，所需的OQ测试按照既定的验收标准按程序定义。（附录中的OQ测试有定义的验收标准示例，以及验收的理由。）当在变更评估中使用多个测试时，不应仅依赖单个OQ测试；相反，应使用OQ测试结果的组合来帮助提供有关辐照器变化的结论的明确理由。 1.5 本指南中的许多计算是使用Microsoft Excel完成的（例如，ANOVA， t -测试， p -但市面上还有许多其他软件工具。 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 操作鉴定（OQ）将用于证明安装的辐照器能够通过剂量映射练习确定剂量分布和大小，并将这些分布与工艺参数相关联，从而按照规定的验收标准操作和向被辐照产品输送剂量。 4.2 OQ的主要目标是: 4.2.1 建立剂量分布并创建基线PQ网格，用于绘制实际产品， 4.2.2 建立剂量均匀率（DUR）与密度的关系， 4.2.3 建立循环时间（CT）与密度和源活度的关系，以及 4.2.4 建立最小剂量（kGy）与密度、循环时间和源放射性的关系。 4.3 OQ练习可以增强或取代PQ练习。当出于PQ目的使用OQ数据时，工厂有责任记录基本原理。 4.4 实验设计方法可能有助于合理化所需的OQ测试类型。对于某些辐照器变化，根据剂量分布的预期变化程度，最小密度数可能不同。这些决策应通过记录在案的变更控制过程来涵盖。见ISO/ASTM 52701 . 4.5 本指南无意解决研究或实验辐照器中的OQ要求。 4. 6. 辐照设施能够处理不同的工艺负荷配置。例如，辐照容器可设计为容纳箱子、袋子和圆桶。重要的是考虑OQ研究，以表征不同辐照几何形状的辐照器。 4.7 体积密度、尺寸和原子组成是剂量映射中的重要属性。看见 附录X2 有关可能用于OQ研究的材料示例。

1.1 This document provides guidance on operational qualification (OQ) tests to meet the OQ requirements defined in ISO 11137-1, ISO 14470, ISO/ASTM 51702 , and ISO/ASTM 52303 for gamma irradiators. 1.1.1 The types of OQ tests are discussed to help the user gain an increased understanding of operational aspects of their irradiator and determine which OQ tests are appropriate for the assessment of irradiator change. 1.1.2 The facility should assess the rationale for the OQ tests chosen and for the ones that have been deemed to be unnecessary. 1.2 Specific requirements for OQ are dependent on the application of the irradiation process and are not within the scope of this guide. For example, requirements for OQ when sterilizing healthcare products can be found in ISO 11137-1. 1.3 A change to the irradiator is a component of the change control process. The OQ testing following the irradiator change is determined as part of the change control documentation and should include rationale to support decision(s) on which tests are required to be completed. 1.4 For an OQ study following an irradiator change, the required OQ tests are defined procedurally with established acceptance criteria. (The OQ tests in the appendixes have examples of defined acceptance criteria with a rationale for the acceptance.) When multiple tests are used in the assessment of change, no individual OQ test should be solely relied upon; rather, the composite of OQ test results should be used to help provide a clear justification for the conclusion regarding irradiator change. 1.5 Many calculations in this guide were completed using Microsoft Excel (for example, ANOVA, t -test, p -value), but numerous other software tools are commercially available. 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 Operational qualification (OQ) will be used to demonstrate that the irradiator, as installed, is capable of operating and delivering dose to product being irradiated with defined acceptance criteria by determining dose distribution and magnitude through dose mapping exercises and relating these distributions to process parameters. 4.2 The principle objectives of OQ are to: 4.2.1 Establish the dose distribution and create a baseline PQ grid for mapping actual product, 4.2.2 Establish the relationship for dose uniformity ratio (DUR) as a function of density, 4.2.3 Establish the relationship for cycle time (CT) as a function of density and source activity, and 4.2.4 Establish the relationship for minimum dose (kGy) as a function of density, cycle time and source activity. 4.3 OQ exercises could augment or replace PQ exercises. It is the facility’s responsibility to document the rationale when using OQ data for PQ purposes. 4.4 A design of experiments approach may help rationalize the types of OQ tests needed. For some irradiator changes, the minimum number of densities may be different depending on the degree of anticipated change in dose distribution. These decisions should be covered through a documented change control process. See ISO/ASTM 52701 . 4.5 This guide is not intended to address OQ requirements in research or experimental irradiators. 4.6 An irradiation facility is able to process different process load configurations. For example, an irradiation container may be designed to accommodate boxes, sacks and drums. It is important to consider OQ studies that characterize the irradiator for different irradiation geometries. 4.7 The bulk density, dimensions and atomic composition are important properties in dose mapping. See Appendix X2 for examples of materials for potential use in OQ studies.