ISO 11608-2:2022 医用针基注射系统 要求和试验方法 第2部分：针

标准编号：ISO 11608-2:2022

中文名称：医用针基注射系统 要求和试验方法 第2部分：针

英文名称：Needle-based injection systems for medical use — Requirements and test methods — Part 2: Double-ended pen needles

发布日期：2022-04

标准范围

This document specifies requirements and test methods for single-use, double-ended, sterile needles intended to be used with some needle-based injection systems (NISs) that use a non-integrated double- ended needle according to ISO 11608-1.
This document is not applicable to the following:
— needles for dental use;
— pre-attached syringe needles;
— hypodermic needles;
— needles intended for different routes of administration (e.g. intravenous, intrathecal, intraocular);
— materials that form the medicinal product contact surfaces of the primary container closure.

标准预览图