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AAMI 2700-1 – Medical Devices and Medical Systems – Essential safety and performance requirements for equipment comprising the patient-centric integrated clinical environment (ICE) – Part 1: General requirements and conceptual model

This standard specifies general requirements, a model, and framework for integrating equipment to create an INTEGRATED CLINICAL ENVIRONMENT (ICE), as defined in 3.6. This standard specifies the characteristics necessary for the safe integration of MEDICAL DEVICES and other equipment, via an electronic interface, from different MANUFACTURERS into a single medical system for the care of a single high acuity PATIENT. This standard establishes requirements for a medical system that is intended to have greater error resistance and improved PATIENT safety, treatment efficacy, and workflow efficiency than can be achieved with independently used MEDICAL DEVICES. This series of standards establishes requirements for design, verification, and validation processes of a model-based integration system for an INTEGRATED CLINICAL ENVIRONMENT. This series of standards is intended to define the requirements essential for safety and thereby facilitate regulatory acceptance.