本文件规定了比较正畸托槽和管的功能尺寸及其化学离子释放的要求和测试方法，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。 本文件未规定免受生物危害的具体定性和定量要求；ISO 10993-1和ISO 7405中涵盖了这些标准。

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.