Fiber review, guiding principles designed to guide and standardize the technical review, the second category of fiber endoscope products help inspectors to enhance the product mechanism, structure, main properties, the understanding of the intended use and so on, convenient censors in the product registration is required to grasp the basic technical evaluation and scale. In addition, because our country medical device regulatory framework is still in building, fiber censors still need to pay close attention to the related standard and the change of the registration regulations, declaration to confirm the product is in compliance with regulations.
For fiber review this strict legal work, all staff have to clear some of the key points of technical review, review such ability of the fibers, do good responsible. Technology review key points include: (1) the product name 1. The upper gastrointestinal tract mirror, other name: "fiber upper gastrointestinal mirror"; 2. Colonoscopy, other name: "colon speculum"; 3. Colonoscopy, other name: "fiber colonoscopy"; 4. Bronchoscopy, other name: "gas observation mirror". (2) the structure and composition of products (1) beams and guidance as separate fiber endoscope (2) guide beams and guide as bundle fiber endoscope .
Fiber review, the examination instrument requirements is also very nice. Just as mentioned instruments. And how it works Observe by optical fiber endoscope system, lighting of transmission system and support components. Optical observation system by focusing on the imaging lens group, the transmission objective as pass/roll like group and visual observation with the eyepiece or transfer CCD lens; Light transmission system consists of mixed arrangement of beam of light more fiber; Bracket component by supporting and package the system and open surgery and/or flushing channel of medical metal and/or organic material. So, understand the working principle of the censors, also know the basic structure of it, I believe that for this kind of fiber, was a cinch.