ISO/TR 80001-2-6:2014 信息技术网络包含医疗器械的风险管理应用 第2-6部分：应用指南 责任协议指南

标准编号：ISO/TR 80001-2-6:2014

中文名称：信息技术网络包含医疗器械的风险管理应用 第2-6部分：应用指南 责任协议指南

英文名称：Application of risk management for IT-networks incorporating medical devices — Part 2-6: Application guidance — Guidance for responsibility agreements

发布日期：2014-12

标准范围

1.1PurposeThis Technical Report provides guidance on implementing RESPONSIBILITY AGREEMENTS, which are described in IEC 80001-1 as used to establish the roles and responsibilities among the stakeholders engaged in the incorporation of a MEDICAL DEVICE into an IT-NETWORK in order to support compliance to IEC 80001-1. Stakeholders may include RESPONSIBLE ORGANIZATIONS, IT suppliers, MEDICAL DEVICE manufacturers and others. The goal of the RESPONSIBILITY AGREEMENT is that these roles and responsibilities should cover the complete lifecycle of the resulting MEDICAL IT-NETWORK.1.2PrerequisitesThe RESPONSIBLE ORGANIZATION’S (ROs) TOP MANAGEMENT has accepted responsibility for the successful implementation of IEC 80001-1. As required by IEC 80001-1, the RO has created and approved policies for the RISK MANAGEMENT PROCESS and RISK acceptability criteria while balancing the three KEY PROPERTIES with the mission of the RO. The RO has identified and provisioned adequate resources and assigned qualified personnel to perform tasks related to the standard. The RO has appointed a MEDICAL IT-NETWORK RISK MANAGER and is prepared to establish the RESPONSIBILITY AGREEMENT.

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