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AAMI TIR75:2019
Factors to consider when multi-vendor devices interact via an electronic interface: Practical applications and examples
This document is intended to assist stakeholders in considering risks associated with connectivity when designing, testing, installing, and maintaining devices that interact via an electronic interface. It identifies specific factors that should be considered as part of risk management activities. It also provides examples where these factors are used to identify causes, hazards, and hazardous situations related to interoperability. These factors can be relevant throughout the lifecycle of connected products.
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Association for the Advancement of Medical Instrumentation [aami]
