标准摘要
[中文适用范围]: 本标准规定了一次性使用攻丝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攻丝式真皮针。 本标准规定了攻丝式真皮针的外观清洁度、耐腐蚀性、无菌性、包装与标识、运输和贮存的结构尺寸、材料和性能要求。 它不适用于滚轮式真皮针、可重复使用的攻丝式真皮针或带有可拆卸攻丝头的装置。 [外文原描述]: 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.
英文名称Traditional Chinese medicine — Dermal needles for single use — Part 1: Tapping-type