牙科-口腔内摄像头

[中文适用范围]： 本文件规定了牙科中用于患者口腔图像表现的口腔内窥镜的要求和测试方法，以支持诊断并方便患者获取信息。 它规定了要求、测试方法、使用说明和标记。 本文件不适用于： a) 用于牙科材料聚合的动力聚合活化剂； c) 用于微创治疗的牙科显微镜； e) 用于牙齿照明（透照）的照相手机； b) 专门用于准备概览或记录治疗的口外摄像设备； d) 医用内窥镜； f) CAD 或 CAM 扫描仪手机； g) 具有摄像功能的牙科器械组合； h) 用于牙髓用途的摄像机； i) j) 根管检查设备（内窥镜微型摄像机）；用于工具导航的摄像头； k) 用于确定牙齿颜色的相机。 [外文原描述]： This document specifies requirements and test methods for intraoral cameras used in dentistry on patients for pictorial representation of oral cavities in order to support diagnosis and facilitate patient information. It specifies requirements, test methods, instructions for use and marking. This document is not applicable to: a) powered polymerization activators for polymerization of dental materials; b) exclusively extraoral camera equipment to prepare overviews or to record treatments; c) dental microscopes for minimally invasive treatments; d) medical endoscopes; e) camera handpieces for tooth illumination (transillumination); f) CAD or CAM scanner handpieces; g) combinations of dental instruments with camera functions; h) cameras for endodontic purposes; i) devices for root canal inspection (endoscopic microcameras); j) cameras for tool navigation; k) cameras for determination of tooth colour.