IT & Software

This technical information report provides medical device manufacturers with guidance on developing a cybersecurity risk management process for their products.

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This technical information report applies to medical devices and systems (also known as medical electrical equipment) that incorporate Radio Frequency (RF) wireless technology used to perform or control a medical function or to communicate medical data.

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This technical information report provides a summary of the differences ISO 11135:2014, Sterilization of health care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices and its previous version of this standard, ISO 11135-1:2007, and its accompanying guidance document, ISO 11135-2:2008.

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Application of risk management for IT networks incorporating medical devices - Part 1: Roles, responsibilities and activities.

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Computerized Maintenance Management Systems for Healthcare Technology Management, 3rd Edition

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This handbook seeks to put readers on the right path for applying IEC 80001 — the sweeping new standard on the application of risk management for information technology (IT) networks that incorporate medical devices.

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Focusing on its recent proliferation in hospital systems, Wi-Fi Enabled Healthcare explains how Wi-Fi is transforming clinical work flows and infusing new life into the types of mobile devices being implemented in hospitals.

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