医用电气设备 第2-64部分：轻离子束医用电气设备的基本安全和基本性能专用要求

[中文适用范围]： IEC 60601-2-64:2025 RLV 包含正式的 IEC 国际标准及其红线版本。红线版本仅提供英文版，便于用户快速比较正式 IEC 标准与其前一版本之间的所有修改内容。IEC 60601-2-64:2025 适用于用于患者治疗的轻离子束医疗设备（以下简称“医疗设备”）的基本安全和基本性能。如果某条款或子条款仅适用于医疗设备或仅适用于医疗系统，其标题和内容将明确说明。否则，该条款或子条款将同时适用于医疗设备和医疗系统，视具体情况而定。 本文件通过包含类型测试和现场测试，分别适用于轻离子束医疗设备的制造商和指定安装方面。该设备用于人类医疗实践中的放射治疗，包括那些可由可编程电子子系统（PESS）自动控制操作参数选择和显示的设备。在正常使用情况下，设备应发射能量为每个核子 10 MeV/n 至 500 MeV/n 的轻离子辐射束，并且应由具有特定医学应用技能的操作员，在适当授权或合格人员的监督下，按照使用说明中的建议进行操作和维护，以满足特定的临床用途。该设备应接受合格人员的定期质量保证性能和校准检查。 IEC 60601-2-64:2025 取代并替代了 2014 年发布的首版标准。本版为技术修订版。与前一版相比，本版包括以下重大技术变更：a) 与 IEC 60601-1:2005、IEC 60601-1:2005/AMD1:2011 和 IEC 60601-1:2005/AMD2:2020 协调一致；b) 与 IEC 62667:2017 协调一致，用于定义术语和定义；c) 对照射场外的中子进行修订。 [外文原描述]： IEC 60601-2-64:2025 RLV contains both the official IEC International Standard and its Redline version. The Redline version is available in English only and provides you with a quick and easy way to compare all the changes between the official IEC Standard and its previous edition. IEC 60601-2-64:2025 applies to the BASIC SAFETY and essential performance of LIGHT ION BEAM 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 manufacturer and specified installation aspects of LIGHT ION BEAM 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 a RADIATION BEAM of LIGHT IONS having ENERGY PER NUCLEON in the range 10 MeV/n to 500 MeV/n, 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. IEC 60601-2-64:2025 cancels and replaces the first edition published in 2014. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) harmonization with IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2011 and IEC 60601-1:2005/AMD2:2020; b) harmonization with IEC 62667:2017 for defined terms and definitions; c) address revision to neutrons outside the field of irradiation.