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AAMI TIR105:2020

M00010990

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AAMI TIR105:2020 Risk management guidance for combination products

standard by Association for the Advancement of Medical Instrumentation, 09/10/2020

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This technical information report provides recommendations and processes to assist manufacturers of combination products in identifying hazards associated with the combination product, assessing associated risks, selecting options for controlling these risks, and monitoring the effectiveness of the implemented controls.