This standard specifies general requirements, a model andframework for integrating equipment to create a INTEGRATED CLINICALENVIRONMENT (ICE), as defined in 3.6. This standard specifies thecharacteristics necessary for the safe integration of MEDICALDEVICES and other equipment, via an electronic interface, fromdifferent MANUFACTURERS into a single medical system for the careof a single high acuity PATIENT. This standard establishesrequirements for a medical system that is intended to have greatererror resistance and improved PATIENT safety, treatment efficacyand workflow efficiency than can be achieved with independentlyused MEDICAL DEVICES.

This series of standards establishes requirements for design,verification, and validation processes of a modelbased integrationsystem for an INTEGRATED CLINICAL ENVIRONMENT.

This series of standards is intended to define the requirementsessential for safety and thereby facilitate regulatory acceptance.NOTE These requirements were derived to support the clinicalscenarios or clinical concepts of operations described in AnnexB.