医用电气设备.第4-5部分:指南和解释.安全相关技术安全规范

[中文适用范围]： 本文件是技术报告，为用于医疗 IT 网络中医疗设备的安全功能提供详细技术规范。本文件涉及的医疗设备包括医疗电气设备、医疗电气系统和医疗设备软件。医疗设备软件虽然不在 IEC 60601（所有部分）的范围内，但也可利用本文件。基于 IEC TS 62443-1-1:2009 [4] 中描述的最新技术状态的七个基础要求，本文件为不同的医疗设备能力安全级别（SL-C）提供了规范。指定的医疗设备安全功能可由医疗界的各种成员用于将设备正确集成到具有适当医疗 IT 网络目标安全级别（SL-T）的医疗 IT 网络的安全区域和通道中。本文件适用于具有外部数据接口的医疗设备，例如连接到医疗 IT 网络或用于处理机密数据（如输入、捕获或查看）的人机接口。本文件不适用于医疗 IT 网络中不符合医疗设备软件定义的其他软件。本文件也不适用于体外诊断设备（IVD）。 [外文原描述]： IEC TR 60601-4-5:2021 provides detailed technical specifications for SECURITY features of MEDICAL DEVICES used in MEDICAL IT-NETWORKS. MEDICAL DEVICES dealt with in this document include MEDICAL ELECTRICAL EQUIPMENT, MEDICAL ELECTRICAL SYSTEMS and MEDICAL DEVICE SOFTWARE. MEDICAL DEVICE SOFTWARE, although not in the scope of IEC 60601 (all parts), can also make use of this document. Based on the seven foundational requirements described in the state-of-the-art document IEC TS 62443 1 1:2009, this document provides specifications for different MEDICAL DEVICE capability SECURITY LEVELS (SL C). The specified SECURITY capabilities of a MEDICAL DEVICE can be used by various members of the medical community to integrate the device correctly into defined SECURITY ZONES and CONDUITS of a MEDICAL IT-NETWORK with an appropriate MEDICAL IT NETWORK's target SECURITY LEVEL (SL T). This document is applicable to MEDICAL DEVICES with external data interface(s), for example when connected to a MEDICAL IT-NETWORK or when a human interface is used for processing – e.g. entering, capturing or viewing – CONFIDENTIAL DATA. This document does not apply to other software used on a MEDICAL IT-NETWORK which does not meet the definition of MEDICAL DEVICE SOFTWARE. This document does not apply to in-vitro diagnostic devices (IVD).