医疗电气设备 - 第2-93部分：中子俘获治疗设备基本安全和基本性能的特殊要求

[中文适用范围]： 本终稿国际标准为官方出版物发布前约6周的预发行版本，其投票期（2026年6月5日至2026年7月17日）内可供销售。若此时购买此FDIS，将自动获赠最终出版物。 IEC 60601-2-93:2026适用于用于患者治疗的加速器中子俘获治疗（NCT）医用设备（以下简称“医用设备”）的基本安全性和关键性能。 若某条款或子条款明确仅适用于医用设备或仅适用于医用系统，则该条款或子条款的标题及内容将予以说明；否则，该条款或子条款应同时适用于医用设备和医用系统（视具体情况而定）。 本文档（含型式试验和现场试验）分别适用于以下方面： - 在人类医学实践中用于放射治疗的NCT医用设备的制造及部分安装环节； - 该类设备中，操作参数的选择与显示可由可编程电子子系统（PESS）自动控制； - 设备在正常使用条件下，通过带电粒子加速器产生的中子进行治疗； - 设备在正常使用中，须由具备相应专业技能的操作人员，在持有相应资质或经合格人员授权下，用于特定的临床目的，且相关操作应遵照《使用说明书》中的建议执行； - 设备需定期接受合格人员开展的质量保证性能评估与校准核查。 [外文原描述]： This Final Draft International Standard is an up to 6 weeks' pre-release of the official publication. It is available for sale during its voting period: 2026-06-05 to 2026-07-17. By purchasing this FDIS now, you will automatically receive, in addition, the final publication. IEC 60601-2-93:2026 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of accelerator-based NCT ME EQUIPMENT, hereafter referred to as ME EQUIPMENT, used for TREATMENT of PATIENTS. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. This document, with the inclusion of TYPE TESTS and SITE TESTS, applies respectively to the manufacture and some installation aspects of NCT ME EQUIPMENT – intended for RADIOTHERAPY in human medical practice, including those in which the selection and DISPLAY of operating parameters can be controlled automatically by PROGRAMMABLE ELECTRONIC SUBSYSTEMS (PESS), – that, in NORMAL USE, deliver NEUTRONS produced by charged particles accelerated by a particle accelerator, and – intended to be • for NORMAL USE, operated under the authority of appropriately licensed or QUALIFIED PERSONS by OPERATORS having the required skills for a particular medical application, for particular SPECIFIED clinical purposes maintained in accordance with the recommendations given in the INSTRUCTIONS FOR USE, • subject to regular QUALITY ASSURANCE performance and calibration checks by a QUALIFIED PERSON.