ISO 11608-3:2022 医用针式注射系统 要求和试验方法 第3部分：成品容器

标准编号：ISO 11608-3:2022

中文名称：医用针式注射系统 要求和试验方法 第3部分：成品容器

英文名称：Needle-based injection systems for medical use — Requirements and test methods — Part 3: Containers and integrated fluid paths

发布日期：2022-04

标准范围

本文件规定了根据ISO？11608-1对针式注射系统（NISs）使用的容器和集成流体通道进行设计验证的要求和试验方法。它适用于由制造商（主容器密封）或最终用户（贮存器）（例如药筒、注射器）填充的单剂量和多剂量容器，以及在制造点与NIS集成的流体路径。当与NIS一起使用时，本文件也适用于预填充注射器（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；-？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；-？可多次重新填充的容器；-？牙科用容器；-？由用户单独连接或组装的导管或输液器。

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.

标准预览图