本文件规定了一次性使用滚筒式皮肤针的基本安全和基本性能的特殊要求。它适用于具有穿透皮肤能力的滚筒式真皮针。 它规定了滚筒式真皮针的外观和清洁度、耐腐蚀性、无菌性、包装和标识、运输和储存的结构和尺寸、材料和性能要求。 它不适用于攻丝式皮肤针或可重复使用的滚筒式皮肤针。

This document specifies the particular requirements for the basic safety and essential performance of roller-type dermal needles for single use. It applies to roller-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 roller-type dermal needles. It does not apply to tapping-type dermal needles or reusable roller-type dermal needles.