医用电气设备 第2-68部分：与电子加速器、轻离子束治疗设备和放射性核素束一起使用的X射线图像引导放射治疗设备的基本安全和基本性能的特殊要求

[中文适用范围]： IEC 60601-2-68:2025 红色线版本（RLV）包含官方的国际电工委员会（IEC）国际标准及其红色线修订版。红色线版本仅提供英文版本，为您提供了一种快速简便的方式比较官方IEC标准与其前一版本之间的所有更改。IEC 60601-2-68:2025适用于基于X射线的图像引导放射治疗（IGRT）设备的基本安全性和固有性能，这些设备与外部束设备（EBE）一起使用。本文件涵盖了千伏（kV）和兆伏特（MV）X射线成像装置的安全方面，这些装置以特定几何关系集成到EBE中，用于IGRT目的。它涉及外部束设备与X射线成像装置之间的通信和关系，无论是否直接连接，但位于同一辐射屏蔽区域内，并且仅用于与外部束设备一起使用。 本文件涵盖了离线、在线和实时X-IGRT设备。它包括了减少对X-IGRT EBE系统过度依赖风险的程序。例如，在线X-IGRT的情况下，制造商将提供一个交互式界面供用户与系统建议的校正进行互动。本文件不适用于CT扫描仪、用于放射摄影或荧光透视的X射线设备，因为这些设备并非用于IGRT用途。 如果根据另一标准正在测试要求，制造商可以识别并确认其等效性，则无需重复测试，而是可以通过CT扫描仪、放射摄影X射线设备或荧光透视X射线设备制造商提供的符合声明或测试报告作为证据。如果X-IGRT设备与医疗电子设备（MEE）结合使用，任何在X-IGRT设备和MEE之间相同的通用要求，例如患者定位器，则无需重复测试，而可以接受由MEE进行的测试。 本文件适用于用于放射摄影、荧光透视和计算机断层成像（CT）的X射线设备，这些设备用于IGRT。如果某一条款或子条款明确仅适用于X-IGRT EBE系统，则该条款或子条款的内容会说明这一点。否则，该条款或子条款仅适用于X-IGRT设备。 本文件包含类型测试和现场测试，分别适用于计划用于以下目的的X-IGRT EBE系统的制造商及相关安装方面： • 正常使用：由合格人员在负责任组织的授权下操作，为特定医学应用和特定指定临床目标（例如固定束放射治疗或移动束放射治疗）而设计。 • 按照使用说明中的建议进行维护。 • 定期接受合格人员的质量保证性能检查和校准检验。 IEC 60601-2-68:2024取代了2014年发布的第1版。本版本构成技术修订。与前一版本相比，本版本引入了以下重大技术变化： a) 与相关标准的新版本对齐： – IEC 60601-2-1:2020； – IEC 60601-2-44:2009，IEC 60601-2-44:2009/AMD1:2012和IEC 60601-2-44:2009/AMD2:2016； – IEC 60601-2-64:2014； b) 对CT扫描仪、放射摄影X射线设备和荧光透视X射线设备的使用范围进行了澄清，这些设备与外部束设备（EBE）位于同一房间内。 c) 引入了与机械危害、辐射危害、可编程电子医疗系统（PEMS）、ME系统随附文件以及远程操作相关的更新要求。 [外文原描述]： IEC 60601-2-68:2025 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 60601-2-68:2025 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of X-ray based IMAGE-GUIDED RADIOTHERAPY equipment for use with EXTERNAL BEAM EQUIPMENT (EBE). This document covers safety aspects of kilovoltage (kV) and megavoltage (MV) X-ray imaging devices integrated in a specified geometrical relationship with EBE for the purpose of IGRT. It covers aspects of communication and relationships between the EXTERNAL BEAM EQUIPMENT and X-ray imaging devices, attached or not directly attached to, but in the same RADIATION shielded area as, and dedicated for use only with, the EXTERNAL BEAM EQUIPMENT. This document deals with equipment for OFFLINE X-IGRT, ONLINE X-IGRT and REAL-TIME X-IGRT. It covers procedures to reduce the risk of over-reliance on the X-IGRT EBE SYSTEM. For example, in the case of ONLINE X-IGRT, the MANUFACTURER will provide an interactive interface for user interaction with the correction suggested by the system. This document does not apply to CT SCANNERS, X-RAY EQUIPMENT for RADIOGRAPHY, and X-RAY EQUIPMENT for RADIOSCOPY, which are not intended for use for IGRT. Requirements that are being tested according to another standard can be identified by the manufacturer and if equivalent do not require retesting, instead evidence can refer to the CT SCANNER, X-RAY EQUIPMENT for RADIOGRAPHY, or X-RAY EQUIPMENT for RADIOSCOPY EQUIPMENT manufacturer's providing compliance statements or test reports. If the X-IGRT EQUIPMENT is combined with an MEE, any requirement that is the same for the X-IGRT EQUIPMENT and the MEE, such as a PATIENT POSITIONER, is not required to be tested twice, but can be accepted as tested by the MEE. This document applies for X-ray equipment for radiography, radioscopy, and COMPUTER tomography used for IGRT. If a clause or subclause is specifically intended to be applicable to X-IGRT EBE SYSTEMS, the content of that clause or subclause will say so. Where that is not the case, the clause or subclause applies only to X-IGRT EQUIPMENT. This document, with the inclusion of TYPE TESTS and SITE TESTS, applies respectively to the MANUFACTURER and some installation aspects of X-IGRT EBE SYSTEMS intended to be: • for NORMAL USE, operated under the authority of the RESPONSIBLE ORGANIZATION by QUALIFIED PERSONS having the required skills for a particular medical application, for particular specified clinical purposes, e.g., STATIONARY RADIOTHERAPY or MOVING BEAM RADIOTHERAPY, • maintained in accordance with the recommendations given in the INSTRUCTIONS FOR USE, and • subject to regular quality assurance performance and calibration checks by a QUALIFIED PERSON. IEC 80601-2-68:2024 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) alignment with the new editions of the relevant standards: – IEC 60601-2-1:2020; – IEC 60601-2-44:2009, IEC 60601-2-44:2009/AMD1:2012 and IEC 60601-2-44:2009/AMD2:2016; – IEC 60601-2-64:2014; b) clarification of the use of IEC 60601-2-68 for CT SCANNERS, X-RAY EQUIPMENT for RADIOGRAPHY and RADIOSCOPY used in the same room with an EXTERNAL BEAM EQUIPMENT (EBE); c) introduction of updated requirements related to MECHANICAL HAZARDS, RADIATION HAZARDS, PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS), ACCOMPANYING DOCUMENTATION of an ME SYSTEM, and REMOTE OPERATION.