标准摘要
[中文适用范围]： 本文件规定了根据 ISO 11608-1 与针基注射系统 (NIS) 一起使用的容器和集成流体路径的设计验证的要求和测试方法。 它适用于由制造商（主容器封闭件）或最终用户（储液器）（例如药筒、注射器）填充的单剂量和多剂量容器以及在制造时与NIS 集成的流体路径。 本文件也适用于与 NIS 一起使用的预充式注射器（参见 ISO 11040-8）（另请参见 ISO 11608-1:2022 的范围）。 本文件不适用于以下产品： ——无菌皮下注射针头； ——无菌皮下注射器； ——用于胰岛素的无菌一次性注射器，带或不带针头； ——可以多次重新填充的容器； ——用于牙科用途的容器； ——由用户单独连接或组装的导管或输液器。 [外文原描述]： This document specifies requirements and test methods for design verification of containers and integrated fluid paths used with Needle-Based Injection Systems (NISs) according to ISO 11608-1. It is applicable to single and multi-dose containers either filled by the manufacturer (primary container closure) or by the end-user (reservoir) (e.g. cartridges, syringes) and fluid paths that are integrated with the NIS at the point of manufacture. This document is also applicable to prefilled syringes (see ISO 11040-8) when used with a NIS (see also scope of ISO 11608-1:2022). This document is not applicable to the following products: — sterile hypodermic needles; — sterile hypodermic syringes; — sterile single-use syringes, with or without needle, for insulin; — containers that can be refilled multiple times; — containers intended for dental use; — catheters or infusion sets that are attached or assembled separately by the user.
英文名称Needle-based injection systems for medical use — Requirements and test methods — Part 3: Containers and integrated fluid paths