含有高活度密封放射源的医疗电气设备安全要求

[中文适用范围]： IEC 63322:2025 规定了用于医疗治疗及其他临床程序中，直接或间接使用高活度密封放射性源的医用电气设备（ME设备）的安全要求。凡含有国际原子能机构（IAEA）定义为1类、2类或3类放射性源的密封放射性源的医用电气设备，均需遵循本文件。本文件旨在明确对含有高活度密封放射性源的医用电气设备的安全要求，以最大限度降低未经授权访问所含密封放射性源的风险，并作为制定其他标准的基础。本文件分别规定了医用电气设备制造商以及设备使用和储存地点的负责机构在安全方面的相关要求。本文件的要求适用于密封放射性源被包含在医用电气设备中的情况，即从密封放射性源被安装到设备中的时刻起，直至设备停止使用并被废弃，即所有密封放射性源被永久从设备中移除为止。 [外文原描述]： IEC 63322:2025 establishes security requirements of ME EQUIPMENT using high-activity SEALED RADIOACTIVE SOURCES, directly or indirectly, for medical treatment and other clinical procedures. ME EQUIPMENT containing SEALED RADIOACTIVE SOURCES that are defined as Category 1, 2 and 3 RADIOACTIVE SOURCES by IAEA are subject to this document. The object of this document is to specify requirements for the security of ME EQUIPMENT containing high-activity SEALED RADIOACTIVE SOURCES with the aim to minimize the risk of unauthorized access to the contained SEALED RADIOACTIVE SOURCES, and to serve as the basis for other standards. This document contains requirements for the MANUFACTURER of the ME EQUIPMENT and, separately, for the RESPONSIBLE ORGANIZATION regarding security at the location during use and storage. The requirements of this document apply when the SEALED RADIOACTIVE SOURCES are contained in the ME EQUIPMENT, i.e. from the time when the SEALED RADIOACTIVE SOURCES are inserted into the ME EQUIPMENT, during the INTENDED USE and when the ME EQUIPMENT is not being used for its INTENDED USE or taken out of regular use, until the equipment is being decommissioned, i.e. until all SEALED RADIOACTIVE SOURCES are permanently removed from the equipment.