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现行 AAMI/IEC TIR80001-2-1:2012
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Application of risk management for IT-networks incorporating medical devices - Part 2-1: Step by step risk management of medical IT-networks; Practical applications and examples 包含医疗设备的IT网络的风险管理应用.第2-1部分:医疗IT网络的逐步风险管理;实际应用和例子
发布日期: 2012-09-02
IEC/TR 80001-2-1:2012是一份技术报告,是在创建或更改医疗IT网络时帮助应用风险管理的分步指南。它提供了易于应用的步骤、示例和信息,有助于识别和控制风险。解决了IEC 80001-1:2010中的所有相关要求,并在适当情况下解决了与IEC 80001-1其他条款和子条款的链接(例如,移交至发布管理和监控)。本技术报告侧重于实际风险管理。本标准并不打算对IEC 80001中令人满意地涵盖的所有要求进行全面概述或解释- 1.本分步指南遵循IEC 80001-1:2010第4.4款规定的10步流程,该流程专门针对风险分析、风险评估和风险控制。这些活动包含在整个生命周期风险管理过程中。它们永远不可能是第一步,因为风险管理遵循的是将计划置于任何行动之前的一般流程模型。
IEC/TR 80001-2-1:2012, which is a technical report, is a step-by-step guide to help in the application of risk management when creating or changing a medical IT-network. It provides easy to apply steps, examples, and information helping in the identification and control of risks. All relevant requirements in IEC 80001-1:2010 are addressed and links to other clauses and subclauses of IEC 80001-1 are addressed where appropriate (e.g. handover to release management and monitoring). This technical report focuses on practical risk management. It is not intended to provide a full outline or explanation of all requirements that are satisfactorily covered by IEC 80001-1. This step-by-step guidance follows a 10-step process that follows subclause 4.4 of IEC 80001-1:2010, which specifically addresses risk analysis, risk evaluation and risk control. These activities are embedded within the full life cycle risk management process. They can never be the first step, as risk management follows the general process model which sets planning before any action.
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