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Medical Device Information Model

A foundational information component of our medical device testing efforts consists of a standards-based schema developed by NIST researchers to assist medical device domain experts. Central to our approach is a standards-based information model written in XML. The electronic equivalant of the ISO/IEEE 11073 Domain Information Model (DIM) enables the representation of medical devices and Implementation Conformance Statements (ICSs). The abstract representation is used to capture medical device implementation details by specifying exactly which features are implemented by a medical device.

Conformance statements, produced by device manufactures and implementers, provide an effective way to increase the likelihood of communicating data correctly. Data must be consistently represented syntactically and semantically for the successful interpretation of medical devices over varying makes and models. A common representation of the base information model is also essential for two or more devices to achieve any level of interoperability.

The NIST developed XML Schema has been accepted by the IEEE to become a normative addition to the ISO/IEEE 11073 Domain Information Model as part 10202. Work on the XSchema is on-going within the X73 working group. Participation and contributions to the working group is welcomed and encouraged to provide a comprehensive and industry vetted information source.

Download NIST developed freely available (disclaimer) XML Schema file(s) here.

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Date created: September 18, 2007
Last updated: September 21, 2007

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