放射性核素校准仪使用中的校准与质量控制

[中文适用范围]： IEC 63465:2026 规定了用于放射性源活度测量的加压井型电离室的校准和使用技术。此类仪器用于测定光子及部分中高能β射线发射体的活度，单位为贝克勒尔（Bq）。本文件针对设备制造商、国家计量院、指定机构、放射性核素生产商、供应商、分销商及最终用户（如核医学设施、工业或医院（放射）药房、研究实验室和核电站）使用的电离室和放射性核素校准仪的校准程序。本文件提供了建立设备可接受性以及保持仪器性能符合要求的方法和测试。由于性能基准因应用不同而异，因此文件中针对最终用户的现场类别仪器和标准实验室及仪器制造商使用的参考类别仪器，分别给出了特定信息。电离室或放射性核素校准仪可作为独立设备使用，也可集成到更大设备中，如层流洁净工作台、通风橱、热室或分装单元。仪器还可以配备一些对设备预期用途至关重要的附件，这些附件的正确使用对放射性核素校准仪的正确使用非常重要，因此也是本文件的适用范围之一。用于控制放射性核素校准仪硬件和运行的软件和计算机系统被视为设备的组成部分，因此也在本文件的适用范围内。IEC 63465:2026 取代并废止了 IEC TR 61948-4:2019、IEC 61303:1994 和 IEC 61145:1992。本版为技术修订版，相对于 IEC TR 61948-4:2019、IEC 61303:1994 和 IEC 61145:1992，主要技术变化包括：a) 技术规范和质量控制程序已更新以适用于现代仪器；b) 对参考类别和现场类别设备的测试验收标准进行了定义；c) 提供了测试数据记录和日志的建议，包括控制图的使用；d) 包括具体的校准指导，其中包括针对最终用户定义的源几何形状的辅助校准指导。 [外文原描述]： IEC 63465:2026 specifies the techniques for calibration and usage of pressurised, well-type ionisation chambers for activity measurements of radioactive sources. Such instruments are used to determine the activity, expressed in becquerel (Bq), of photon and some medium to high-energy beta-emitters. This document addresses calibration procedures of ionisation chambers and radionuclide calibrators to be used by equipment manufacturers, national metrology institutes and designated institutes, radionuclide producers, suppliers, distributors, and end users, like nuclear medicine facilities, industrial or hospital (radio)pharmacies, research laboratories, and nuclear power plants. This document provides the methods and tests for establishing conformity of device acceptability and maintaining acceptable instrument performance. Performance benchmarks vary depending on the application, so information is given specific to field class instruments for end users and reference class instruments for standards laboratories and instrument manufacturers. The ionisation chamber or radionuclide calibrator can be an instrument that is used as a standalone device, but it can also be integrated in a much larger appliance, such as a laminar air flow cabinet, a fume hood, a hot cell, or a dispensing unit. The instrument can also be equipped with accessories that are essential for the intended use of the appliance that surrounds and incorporates the radionuclide calibrator. The proper use of each of the accessories can be important for the correct use of the radionuclide calibrator and therefore is part of the scope of this document. The software and computer system(s) that can be used to control the radionuclide calibrator hardware and functioning are considered an integral part of the device and therefore are also considered part of the scope of this document. IEC 63465:2026 cancels and replaces IEC TR 61948-4:2019, IEC 61303:1994, IEC 61145:1992. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to IEC TR 61948-4:2019, IEC 61303:1994 and IEC 61145:1992: a) technical specifications and quality control procedures are updated to apply to modern instruments; b) test acceptance criteria are defined for reference class and field class devices; c) recommendations are given on recording and logging of test data, including the use of control charts; d) specific calibration guidance is included, including guidance for subsidiary calibrations with end-user-defined source geometries.