标准摘要
[中文适用范围]： 本文件规定了一次性双头无菌针的要求和测试方法，这些针旨在与一些根据 ISO 11608-1 使用非集成双头针的基于针的注射系统 (NIS) 一起使用。 本文件不适用于以下情况： ——牙科用针； ——预装注射器针头； ——皮下注射针头； ——用于不同给药途径的针头（例如静脉内、鞘内、眼内）； ——形成主容器封闭件的药品接触表面的材料。 然而，虽然本文件无意直接应用于这些针产品，但它确实包含可用于帮助设计和评估它们的要求和测试方法。 注：制造商提供的集成到流体路径或容器中的针头被覆盖在 [外文原描述]： 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. However, while this document is not intended to directly apply to these needle products, it does contain requirements and tests methods that can be used to help design and evaluate them. NOTE Needles provided by the manufacturer integrated into the fluid path or container are covered in ISO 11608‑3, and hypodermic needles provided separately are covered in ISO 7864.
英文名称Needle-based injection systems for medical use — Requirements and test methods — Part 2: Double-ended pen needles