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
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).
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