Standard No.:	T/ZMDS 30004-2023
English Name:	Orthodontic removable appliance
Chinese Name:	口腔正畸活动矫治器
Chinese Classification:	C33    Stomatologic device, equipment and material
Professional Classification:	T/    Social Organization Standard
ICS Classification:	11.060.25 11.060.25    Dental instruments 11.060.25
Source Content Issued by:	Zhongguancun Medical Device Industry Technology Innovation Alliance
Issued on:	2023-12-29
Implemented on:	2023-12-29
Status:	valid
Target Language:	English
File Format:	PDF

本文件规定了“口腔正畸活动矫治器”（以下简称矫治器）的分类、设计、性能指标、试验方法、标志的要求。
本文件适用于使用具有医疗器械注册证书的牙科不锈钢丝、正畸丝及基托聚合物等材料生产的，可供患者可由患者自由摘戴使用的矫正器和保持器，用于患者恢复口腔内的牙列错乱、反咬合等情况。本文件不适用于固定矫治器。