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AAMI TIR57

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AAMI TIR57 2016 Edition, January 1, 2016 Technical Information Report: Principles for medical device security-Risk management

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$139.60

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$349.00

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Description / Abstract: Provides guidance on methods to perform information security risk management for a medical device in the context of the Safety Risk Management process required by ISO 14971. The TIR incorporates the expanded view of risk management from IEC 80001-1 by incorporating the same key properties of Safety, Effectiveness and Data Systems Security with Annexes that provide process details and illustrative examples.