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AAMI/IEC TIR80001-2-8:2016

AAMI/IEC TIR80001-2-8:2016

Application of risk management for IT networks incorporating medical devices - Part 2-8: Application guidance Guidance on standards for establishing the security capabilities identified in IEC 80001-2-2

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This technical report provides guidance for the application of the framework outlined in AAMI/IEC 80001-2-2. Managing the RISK in connecting MEDICAL DEVICES to IT-networks requires the disclosure of security-related capabilities and RISKS. AAMI/IEC 80001-2-2 presents a framework for this disclosure and the security dialog that surrounds the AAMI/IEC 80001-1 RISK MANAGEMENT of IT-networks. AAMI/IEC 80001-2-2 presents an informative set of common, descriptive security-related capabilities that are useful in terms of gaining an understanding of user needs. This report addresses each of the SECURITY CAPABILITIES and identifies SECURITY CONTROLS for consideration by all stakeholders during RISK MANAGEMENT activities, supplier selection, device selection etc.

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