AAMI TIR75:2019

This document provides a discussion of the context for important factors and questions that manufacturers should consider when designing, testing, installing, and maintaining connected medical devices. The scope of this TIR includes:

• Considerations for adding interoperability or connectivity to the function of a device
• Modifying existing functionality of a connected device
• Considerations when developing connections between devices from multiple vendors
• Questions manufacturers should ask themselves when adding/modifying interoperable functionality