本文件规定了比较设备功能尺寸的要求和试验方法 正畸托槽和管及其化学离子释放，以及包装和标签 信息 本文件适用于固定式正畸矫治器中使用的托槽和管。 本文件未详细说明免责声明的具体定性和定量要求 生物危害；ISO 10993-1和ISO 7405中涵盖了这些标准。交叉引用:ISO 10271:2011ISO 1942ISO 7405ISO 15841ISO 10993-1购买本文件时可获得的所有现行修订均包含在购买本文件中。

This document specifies requirements and test methods to compare the functional dimensions of orthodontic brackets and tubes and their chemical ion release, as well as packaging and labelling information. This document is applicable to brackets and tubes for use in fixed orthodontic appliances. This document does not specify specific qualitative and quantitative requirements for freedom from biological hazards; which are covered in ISO 10993-1 and ISO 7405.Cross References:ISO 10271:2011ISO 1942ISO 7405ISO 15841ISO 10993-1All current amendments available at time of purchase are included with the purchase of this document.