-
Notifications
You must be signed in to change notification settings - Fork 4
Home
This working group started as a group that wanted to analyse the usage of Linux as a component in an actual, safety relevant device. That activity started with using the openAPS project which lead to having a deeper look into safety relevant and open source projects in the medical world. So mainly our goals are:
- Analysing an actual use case of Linux used in a safety critical device to identify how it is exactly used (and use this as a starting point of qualification)
- Identification of kernel components used by the analysed medical system
- Create input that the architecture work group could use for their work
- Identify already existing methods or standards that allow the integration of pre-existing open source software into safety critical medical devices (SOUP approach acc. to IEC62304)
This working group started as a domain independent group for the analysis of the linux-in-an-embedded-safety-critical-system use case, but with starting the analysis of open source ventilators, the group was re-named to "Medical Devices".
The best way to start will be to follow our first footsteps to quickly catch up with us along the way.
- To learn about STPA as an analysis method: Have a look at the STPA handbook
- What we learned so far about openAPS: Check the openAPS guide
- Our STPA analysis spreadsheet: work in progress - openAPS STPA analysis
- The current evaluation of open source ventilators. Ventilator spreadsheet
- What we are currently up to: Minutes of Meeting
- openAPS in the context of IEC 62304: Whitepaper of the analysis
We could do with a little help! This is a multi-disciplinary topic, so all that can contribute from an embedded systems, medical, functional safety, kernel, safety analysis, ... perspective! Generally we are busy with the following tasks:
- the level 3 analysis of openAPS
- the tracing of the openAPS workload to discover Linux kernel subsystems used by openAPS
- review of all work done so far
- analysis of the open source ventilators
- moving our documents from google docs/spreadsheets to GitHub
The most needed support is currently needed at:
- Getting more feedback/reviewers
- openAPS reviewers
- STPA reviewers
- Linux developer feedback (Plumbers?)
- Moving spreadsheet analysis into github to open for wider review and discussion
- Comparison of results to other existing medical standards (considering IEC 60601 - clause 14)
- Identification of focus person with enough bandwidth to drive Open Source Ventilator, like we’ve got with OpenAPS
For everybody interested, we meet each Wednesday, 11:00am to 12:00pm (UTC-05:00) America/Chicago time.
Contact us at https://lists.elisa.tech/g/medical-devices