Biocompatible Sapphire Optical Window Upgrade for Medical Non-Invasive Sensor Equipment

Engineering samples start at 5 units with a 10 to 15 working day lead time. Production lots typically begin at 100 pieces per month. Felix Glass does not enforce a fixed minimum order quantity on evaluation samples. We quote each program individually based on the dimensional specification, coating requirement and annual volume forecast.

Yes. Synthetic sapphire is chemically inert and thermally stable to approximately 2000 degrees Celsius, well above standard autoclave temperatures. It is compatible with steam autoclave, ethylene oxide gas, gamma irradiation and hydrogen peroxide plasma sterilization. The AR coating is designed and adhesion-tested for repeated sterilization exposure. We recommend specifying the sterilization method during the quoting phase so the coating stack can be validated accordingly.

Sapphire offers approximately 85 to 87 percent broadband transmission from visible through mid-wave infrared compared to fused silica at 92 to 93 percent. However, sapphire provides Mohs 9 surface hardness versus approximately Mohs 6 for fused silica, making it the preferred choice for patient-contact and reusable sensors that undergo repeated cleaning. Fused silica remains a strong option for single-use disposable sensors where cost is the primary driver and mechanical durability requirements are lower. Felix Glass can quote both substrates and help your engineering team evaluate the trade-off.

Felix Glass provides a standard medical device documentation package that includes substrate material certificate with lot traceability from crystal growth through final inspection, ISO 10993-5 cytotoxicity compliance declaration, surface roughness measurement records from Bruker white-light interferometry, dimension verification reports from Mitutoyo CMM, coating transmission curves from PerkinElmer spectrophotometry, and a documented Class 1000 cleanroom packaging procedure. The package is structured to support both FDA 510(k) submissions and CE marking technical documentation under the EU Medical Device Regulation.