医疗器械 第2-64部分：光子束医疗电气设备基本安全和基本性能的特殊要求

[中文适用范围]： IEC 60601-2-64:2025适用于轻离子束医疗设备（以下简称“医疗设备”）的基本安全和基本性能，该设备用于患者的治疗。如果某一条款或子条款仅适用于医疗设备或仅适用于医疗系统，该条款或子条款的标题和内容将明确说明这一点。如果未作如此说明，则该条款或子条款适用于医疗设备和医疗系统，视情况而定。 本文件，包括型式试验和现场试验，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，设备应发射能量每核子在10 MeV/n至500 MeV/n范围内的轻离子辐射束。该设备应： • 在正常使用情况下，由具备相应资质或资格的人员授权操作人员操作，操作人员应具备特定医疗应用所需的技能，按照《使用说明书》中的建议进行特定临床目的的维护； • 由具备资格的人员定期进行质量保证性能和校准检查。 IEC 60601-2-64:2025取代并替代了2014年首次发布的版本。本版为技术修订版。与前一版相比，本版包含以下重大技术更改： 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在定义术语和定义方面协调一致； c) 针对照射区域外的中子进行修订。 [外文原描述]： 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.