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ANSI/AAMI/IEC 80001-1:2010

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

Defines the roles, responsibilities and activities that are necessary for RISK MANAGEMENT of IT-NETWORKS incorporating MEDICAL DEVICES to address SAFETY, EFFECTIVENESS and DATA AND SYSTEM SECURITY(the KEY PROPERTIES).


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Association for the Advancement of Medical Instrumentation [AAMI]


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As the voice of the U.S. standards and conformity assessment system, the American National Standards Institute (ANSI) empowers its members and constituents to strengthen the U.S. marketplace position in the global economy while helping to assure the safety and health of consumers and the protection of the environment.

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