本文件规定了用于成形和清洁根管的手持和机械操作器械的要求和试验方法，ISO 3630系列的其他部分中没有规定。 本文件规定了尺寸、标记、产品名称、安全注意事项、标签和包装的要求。

This document specifies requirements and test methods for hand-held and mechanically operated instruments used for shaping and cleaning root canals, and which are not specified in other parts of the ISO 3630 series. This document specifies requirements for size, marking, product designation, safety considerations, labelling and packaging.