标准摘要
[中文适用范围]： 本文件规定了一次性使用滚轮式真皮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轮式真皮针。 本标准规定了滚轮式真皮针的外观清洁、耐腐蚀、无菌、包装和标识、运输和贮存的结构尺寸、材料和性能要求。 它不适用于攻丝式真皮针或可重复使用的滚筒式真皮针。 [外文原描述]： 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.
英文名称Traditional Chinese medicine — Dermal needles for single use — Part 2: Roller-type