📌 Medical Devices Fastener Stack - Hydrogen embrittlement in high-temperature condensate

Industry: Medical Devices · Severity: Critical · Mechanism: Hydrogen embrittlement · Risk: 96/100

🧾 Summary

A fastener stack used in a medical devices application shows hydrogen embrittlement risk after exposure to high-temperature condensate. The design review focuses on material pairing, geometry, coating coverage, inspection access, and realistic validation testing.

⚠️ Design Risk

Likely weak points include local electrolyte retention, incompatible material pairing, coating discontinuities, trapped debris, and missing acceptance criteria for corrosion validation.

🛠️ Recommended Controls

Recommended controls: coating specification upgrade, drainage path redesign, and passivation requirement. Add drawing notes, supplier evidence requirements, and a validation plan that reflects the expected service environment.

🎓 Learning Notes

Learners should identify the corrosion mechanism, estimate severity, and decide whether prevention should come from material change, coating change, geometry change, sealing, isolation, or inspection planning.