Innovation
Medical Device Leak Testing: Regulatory Requirements and Equipment Selection
Leak testing requirements for medical devices — including regulatory context, SCCM sensitivity thresholds, instrument selection for sterile barrier applications, and surgical instrument validation methods.
Barometric-Immune Leak Testing for Low-Pressure Surgical Instruments
At 10–20 kPa, barometric fluctuation exceeds the ±0.08 kPa acceptance window. How differential-pressure bridge measurement makes surgical instrument testing reliable without a climate-controlled enclosure.
Sub-SCCM Leak Detection at Production Speed for Sterile-Barrier Applications
Detecting leaks below 3 SCCM at 40 mL test volume — how differential-pressure bridge measurement makes Class II sterile-barrier validation reliable at production throughput.