本文件规定了根据ISO 11608-1使用非集成双头针头的一些针头注射系统（NISs）拟使用的一次性、双头无菌针头的要求和测试方法。 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的针头（例如静脉注射、鞘内注射、眼内注射）；-形成主要容器封盖的医药产品接触面的材料。 然而，虽然本文件无意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。

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.