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
Document identifier
AAMI TIR75:2019
Title
Factors to consider when multi-vendor devices interact via an electronic interface: Practical applications and examples
AAMI Category
Electromedical Equipment, Diagnostic and Monitoring
Publication date
2019-06-01
International Relationship
Price |
200 vnd |