IEC TR 60601-4-5:2021 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

标准编号：IEC TR 60601-4-5:2021

中文名称：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

英文名称：Medical electrical equipment - Part 4-5: Guidance and interpretation - Safety-related technical security specifications

发布日期：2021-01-18

标准范围

IEC TR 60601-4-5:20 21为医疗IT网络中使用的医疗设备的安全特性提供了详细的技术规范。本文件涉及的医疗器械包括医疗电气设备、医疗电气系统和医疗器械软件。医疗器械软件虽然不在IEC 60601（所有部分）的范围内，但也可以利用本文件。基于现有技术文件IEC TS 62443 11:20 09中描述的七个基本要求，本文件提供了不同医疗设备能力安全级别(SL C)的规范。医疗设备的指定安全能力可以被医疗社区的各种成员用于将设备正确地集成到医疗IT的定义的安全区域和管道中。具有适当医疗IT网络目标安全级别（SL T）的网络。本文档适用于具有外部数据接口的医疗设备，例如当连接到医疗IT网络时或当人机界面用于处理（例如输入、捕获或查看）机密数据时。本文件不适用于医疗IT网络上使用的不符合医疗器械软件定义的其他软件。本文件不适用于体外诊断器械（IVD）。

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).

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