2 Scope

2.1 This Standard is applicable to interoperable medical products, including assembled systems of interoperable medical products that comprise or are intended to be incorporated into interoperable medical systems within an interoperable environment.

2.2 This Standard specifies a baseline set of integration lifecycle requirements for assuring safe and secure interoperability of interoperable items assembled or otherwise integrated into interoperable medical systems.

Summary of Topics

This is the First Edition of ANSI/AAMI/UL 2800-1-3, the Standard for Interoperable Item Integration Life Cycle.