Open PCA Pump Artifacts
Open PCA Pump Requirements Document
- Open PCA Pump Requirements (.pdf)
This document presents engineering requirements for the Open PCA Pump based on the methodology presented in the
FAA Requirements Engineering Management Handbook (DOT/FAA/AR-08/32). While the requirements do address aspects of the architecture and hardware, the focus is on functional, safety, and security requirements for the system and the software.
- Open PCA Assurance Case Report (.pdf)
This document presents a draft of a safety case for the Open PCA Pump driven, in large part, by hazards identified in the US FDA Guidance on Infusion Pumps. The safety case is built using the NOR-STA assurance case tool.
The assurance case document can also be viewed directly (read only mode) in the web-based NOR-STA tool.