本文件规定了一次性使用轻敲式皮肤针的基本安全和基本性能的特殊要求。适用于能够穿透皮肤的轻敲型真皮针。 它规定了轻敲式皮肤针的结构和尺寸、材料和性能要求，包括外观和清洁度、耐腐蚀性、无菌性、包装和标识、运输和储存。 它不适用于滚筒式真皮针、可重复使用的轻敲式真皮针或包含可拆卸轻敲头的装置。

This document specifies the particular requirements for the basic safety and essential performance of tapping-type dermal needles for single use. It applies to tapping-type dermal needles that have the capacity to penetrate the skin. It specifies structure and dimension, materials, and performance requirements for appearance and cleanliness, corrosion resistance, sterility, packaging and identification, transit and storage of tapping-type dermal needles. It does not apply to roller-type dermal needles, reusable tapping-type dermal needles or devices incorporating a detachable tapping head.