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现行 IEC TR 80001-2-2:2012
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Application of risk management for IT-networks incorporating medical devices - Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls 包含医疗器械的IT网络的风险管理应用第2-2部分:医疗器械安全需求、风险和控制的披露和沟通指南
发布日期: 2012-07-10
IEC/TR 80001-2-2:2012(E)是一份技术报告,为披露管理医疗设备与IT网络连接风险所需的安全相关能力和风险,以及围绕IEC 80001-1 IT网络连接风险管理的安全对话创建了一个框架。本安全报告提供了一组信息丰富的通用高级安全相关功能,有助于了解用户需求、需要考虑的安全控制类型以及导致这些控制的风险。预期用途和当地因素决定了哪些确切的功能在关于风险的对话中是有用的。 本报告中的能力描述旨在为医疗服务组织(HDO)、医疗器械制造商(MDM)和IT供应商提供讨论风险及其各自管理角色和责任的基础。 风险合伙人之间的讨论是IEC 80001-1中规定的一项或多项责任协议的基础。
IEC/TR 80001-2-2:2012(E), which is a technical report, creates a framework for the disclosure of security-related capabilities and risks necessary for managing the risk in connecting medical devices to IT-networks and for the security dialog that surrounds the IEC 80001-1 risk management of IT-network connection. This security report presents an informative set of common, high-level security-related capabilities useful in understanding the user needs, the type of security controls to be considered and the risks that lead to the controls. Intended use and local factors determine which exact capabilities will be useful in the dialog about risk. The capability descriptions in this report are intended to supply health delivery organizations (HDOs), medical device manufacturers (MDMs), and IT vendors with a basis for discussing risk and their respective roles and responsibilities toward its management. This discussion among the risk partners serves as the basis for one or more responsibility agreements as specified in IEC 80001-1.
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归口单位: TC 62/SC 62A
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