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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]


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As the voice of the U.S. standards and conformity assessment system, the American National Standards Institute (ANSI) empowers its members and constituents to strengthen the U.S. marketplace position in the global economy while helping to assure the safety and health of consumers and the protection of the environment.

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