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AAMI/IEC TIR80001-2-4:2012

AAMI/IEC TIR80001-2-4:2012

Application of risk management for IT-networks incorporating medical devices -- Part 2-4: General implementation guidance for healthcare delivery organizations

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This helps a RESPONSIBLE ORGANIZATION through the key decisions and steps required to
establish a RISK MANAGEMENT framework, before the organization embarks on a detailed RISK
ASSESSMENT of an individual instance of a MEDICAL IT-NETWORK. This Technical Report is
addressed to all Healthcare Delivery Organizations. A Healthcare Delivery Organization includes
hospitals, doctors? offices, community care homes and clinics. It identifies a series of decision points
to steer the RESPONSIBLE ORGANIZATION through the process of understanding the MEDICAL
IT-NETWORK context and identifying any organizational changes required before undertaking the
RISK MANAGEMENT PROCESS identified in IEC 80001-1.

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