Requirements for Endoscopic Camera Module To Be Used As Bronchoscopes

For an endoscopic camera module to be used as a bronchoscope, it must first meet extremely high imaging quality requirements, which are central to accurate diagnosis. Its resolution needs to reach high definition (HD) or higher to clearly display tiny lesions on the bronchial mucosa; the field of view (FOV) is typically between 60° and 120° to balance coverage and edge distortion, while the depth of field (DOF) must ensure clear imaging within 5-30mm to adapt to the size of the bronchial lumen and the slight movements caused by breathing. Additionally, a dynamic range of ≥60dB is required to handle light-dark contrasts, a frame rate of ≥30fps to reduce motion blur, and a signal-to-noise ratio (SNR) of ≥40dB to minimize noise in low-light environments. It should be paired with a low-noise medical-grade CMOS or CCD sensor to ensure that even tiny nodules, bleeding points, or mucosal textures can be clearly captured in the complex internal environment of the bronchi. Second, the physical properties and biological safety of the module must be suitable for the clinical operation scenarios of bronchoscopes. Since bronchoscopes need to be inserted through the mouth or nose, the module’s diameter must be ≤5mm, length ≤10mm, and weight ≤1g to ensure the slimness and flexibility of the scope body, avoiding damage to the mucosa. It must also have strong durability to withstand frequent bending and vibration. In terms of biological safety, materials in contact with the human body must comply with ISO 10993 standards, being non-toxic and non-sensitizing. Moreover, it must resist medical disinfection methods such as high-temperature and high-pressure sterilization, ethylene oxide (EtO) sterilization, or low-temperature plasma sterilization, and have an IP68 waterproof seal to prevent liquid infiltration or component corrosion during disinfection. Finally, the module must meet compatibility, functional expansion, and regulatory requirements. The interface should support low-latency transmission (e.g., HDMI 2.0, USB 3.0) with a delay of ≤50ms, be compatible with medical image processing workstations, and support DICOM format output. It needs to integrate algorithms such as digital noise reduction, edge enhancement, and narrow-band imaging (NBI) to assist in identifying early lesions, while being compatible with medical cold light sources and having lenses coated with anti-reflective films to improve light transmittance. Most importantly, it must pass medical certifications such as FDA, CE, and NMPA, comply with the ISO 13485 quality management system, and ensure that parameter deviations between batches are ≤5%, thus guaranteeing the safety and effectiveness of clinical use from a regulatory perspective.