本标准规定了用于根管成形和清洁的手动或机械操作器械的要求和试验方法，其设计或材料不包括在ANSI/ADA第28和58号规范的规定中。本标准的目的是提供一份文件，以确定尺寸和产品名称的方法、安全注意事项，例如断裂力、灵活性和说明/标签的最低要求。

This standard specifies requirements and test methods for hand or mechanically operated instruments for root canal shaping and cleaning having designs or materials which are not included within the provisions of ANSI/ADA Specification Nos. 28 and 58. The purpose of this standard is to provide a document to identify methods for size and product designation, safety considerations, for example, minimum requirements for fracture forces, flexibility, and instructions/labeling.