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现行 ISO 11608-2:2022
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Needle-based injection systems for medical use — Requirements and test methods — Part 2: Double-ended pen needles 医用针头注射系统.要求和试验方法.第2部分:双头笔式针头
发布日期: 2022-04-07
本文件规定了根据ISO?11608-1使用非集成双端针头的一些针头注射系统(NISs)拟使用的单用双端无菌针头的要求和试验方法。 本文件不适用于以下情况: -?牙科用针; -?预先连接的注射器针头; -?皮下注射针; -?用于不同给药途径(如静脉注射、鞘内注射、眼内注射)的针头; -?形成主要容器封盖的医药产品接触面的材料。 然而,虽然本文件不打算直接适用于这些针头产品,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?ISO?11608?3涵盖了制造商提供的集成到流体通道或容器中的针头,ISO 7864涵盖了单独提供的皮下注射针头。
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.
分类信息
发布单位或类别: 国际组织-国际标准化组织
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研制信息
归口单位: ISO/TC 84
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