医疗器械软件 - 放射治疗计划系统的安全要求

[中文适用范围]： IEC 62083:2025（包含型式试验和现场试验）适用于放射治疗计划系统的**设计、制造、安装和维护**。本文件适用于放射治疗计划系统与其他设备之间的通信，这些设备用于医疗实践，其数据通过操作人员输入或其他设备导入，也可将数据输出至其他设备，并且该系统应在以下条件下使用：由具备适当资质的人员在正常情况下使用，由具有必要技能和培训的操作人员操作和维护，按照使用说明中的建议进行使用和维护，并在技术说明中规定的环境条件下使用。本文件适用于任何用于治疗计划的开发、评估或批准的软件应用程序，无论其是独立软件还是其他系统的一部分。 IEC 62083:2025 取代并替代了2009年发布的第二版。本版为技术性修订版，与前一版相比，包含以下重大技术变更：– 将标题由“医用电气系统 – 放射治疗计划系统的安全性要求”修改为“医疗器械软件 – 放射治疗计划系统的安全性要求”；– 增加第16条，内容涉及自适应放射治疗；– 标题反映了放射治疗计划系统的不同实现方式。 [外文原描述]： IEC 62083:2025, with the inclusion of type tests and site tests, applies to the design, manufacture, installation, and maintenance of the radiotherapy treatment planning system. This document applies to the communication of the radiotherapy treatment planning system with other devices – used in medical practice, – that imports data either through input by the operator or from other devices, – that outputs data to other devices, and – that is intended to be - for normal use, under the authority of appropriately qualified persons, by operators having the required skills and training, - used and maintained in accordance with the recommendations given in the instructions for use, and – used within the environmental conditions specified in the technical description. This document applies to any software application that is used for the development, evaluation, or approval of a treatment plan, whether stand-alone or part of another system. IEC 62083:2025 cancels and replaces the second edition published in 2009. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: – modification of the title from Medical electrical system - Requirements for the safety of radiotherapy treatment planning systems, to Medical device software - Requirements for the safety of radiotherapy treatment planning systems; – Adaptive radiotherapy is added with Clause 16; – The title reflects different implementations of radiotherapy treatment planning systems.