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Access guidance documents for methods to perform information security risk management and assessment procedures for medical devices. AAMI TIR57 / ANSI/AAMI HE75 / ISO 10993-10 – Medical Devices Package also includes general human factors engineering (HFE) principles and HFE principles geared towards certain user-interface attributes.
AAMI TIR57 / ANSI/AAMI HE75 / ISO 10993-10 – Medical Devices Package includes:
AAMI TIR57:2016 (R2023)
ANSI/AAMI HE75:2009 (R2018)
ISO 10993-10:2021
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