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AAMI 2800-1:2019
M00011004
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AAMI 2800-1:2019 Standard for Safety for Medical Device Interoperability (ANSI/AAMI/UL 2800-1:2019)
standard by Association for the Advancement of Medical Instrumentation, 02/25/2019
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This standard specifies a baseline set of requirements for assuring safe and secure interoperability for Interoperable Medical Systems.The standard employs a life cycle process approach to organizing requirements, providing a set of interoperability planning, realization, deployment, and monitoring activities that incorporate cross-cutting requirements for security and risk management. AAMI/UL 2800-1 also provides supplementary guidance on key clinical and engineering properties essential for ensuring effective interoperability.