Views: 0 Author: Site Editor Publish Time: 2025-07-16 Origin: Site
To convert an endoscope camera bare module into a medical-grade device, start with the optical system: replace or supplement the stock lens with a purpose-built medical lens that delivers high resolution, the correct field of view and depth of field, and—if required—add fluorescence filters or anti-glare coatings to optimize imaging.
Mechanically, the module must be encased in biocompatible materials (e.g., 316L stainless steel, PEEK) that satisfy ISO 10993 standards. The outer dimensions must be tailored to fit specific anatomical sites, and a bending mechanism should be integrated to enhance maneuverability. Full sealing is essential so the device can withstand sterilization cycles (steam, ETO, or plasma).
A cold-light source must be coupled to the module and its illumination parameters tuned to ensure true-to-life tissue color reproduction. Electrically, the entire system must comply with IEC 60601-1, employing isolation modules and standard connectors to guarantee electrical safety and interoperability. Real-time image processing is handled by a dedicated ISP, and the final software stack must meet medical-device regulations. After passing NMPA, FDA, or equivalent certifications, the endoscope is ready for clinical use.
