1. Scope
This standard establishes the general principles for the design, verification, and validation of the Integrated Clinical Environment (ICE), where ICE is a medical system designed to safely provide data acquisition, and integration and control of a heterogeneous combination of medical devices and other equipment in a high-acuity patient environment. ICE is intended to enable the creation of systems for innovation in patient safety, treatment efficacy, and workflow efficiency.
There is no complete suite of standards, technologies, or solutions available to seamlessly integrate medical devices to produce error-resistant systems. Systems of integrated medical devices will support improvements in workflow and reductions in medical errors and healthcare costs to the benefit of patients throughout the continuum of care: from the home, to pre-hospital transport, and to clinical areas as diverse as the OR, ICU, ED, and general hospital ward. The standard is expected to be adopted by medical equipment manufacturers, healthcare organizations, and governmental agencies.
Keywords
functional safety; interoperability;essential performance; medical device interoperability; medical device integration
The title and scope are in draft form and are under development within this ASTM Committee.
Citing ASTM Standards
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