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第二類硬管內(nèi)窺鏡產(chǎn)品注冊技術(shù)審查指導(dǎo)原則-資料下載頁

2025-10-16 09:17本頁面

【導(dǎo)讀】冊技術(shù)審評時把握基本的要求和尺度。此外,由于我國醫(yī)療。鏡、直腸鏡、羊水鏡。1.喉鏡,其他名稱:“喉內(nèi)窺鏡”;2.鼻竇鏡,其他名稱:“鼻鏡”、“鼻內(nèi)窺鏡”;4.子宮鏡,其他名稱:“子宮腔鏡”、“宮腔鏡”;學(xué)系統(tǒng)、鏡體、光導(dǎo)束接口、目端接管、目鏡罩等組成。膀胱鏡由光學(xué)內(nèi)窺鏡、操作器、鏡鞘、窺鏡橋等組成。束,帶有手柄、鏡盤、注氣嘴、光導(dǎo)束接口等組成的直腸鏡。光導(dǎo)束一般采用不同孔徑的玻璃纖維材料。用的器械國內(nèi)外基本相同,規(guī)格型號有所不同。度,以達(dá)到使用所需的要求。照明傳輸系統(tǒng)由光導(dǎo)纖維組成。和診察,不需切口或打孔穿刺進(jìn)入人體。鏡本身不帶有器械孔道,不配有鏡鞘等,只能做檢查診斷用。在操作膀胱鏡時,先將鞘套與閉孔器插入尿道及膀胱,應(yīng)的內(nèi)膜活檢、輸卵管插管注藥、分離粘連等手術(shù)。鏡,可在內(nèi)窺鏡直視下活檢取樣,摘除息肉。膀胱鏡工作長度≥300mm;膀胱鏡外徑尺寸Φ3mm、Φ4mm;、21Fr、23Fr,國外常用24Fr、25Fr;

  

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