Formal Oxygen Fire Risk Analysis (Level 3).
The WHA signature oxygen fire risk analysis (OFRA) method is our most detailed and extensive oxygen hazards analysis for systems and components. The Level 3 OFRA method provides formal documentation of each phase of the analysis process with thorough referencing to supporting data for rating materials flammability, ignition probability, and fire consequence. This risk analysis approach is also consistent with the qualitative risk analysis approach outlined in ISO 14971 for medical devices.
A formal OFRA report typically includes the system-level component listing and analysis results (if applicable) and individual component OFRA worksheets that document the component piece-part analyses of material flammability, ignition probability, and ignition consequence. The report discusses all results and provides recommendations as needed To achieve a low probability of ignition and a low consequence of ignition.