标准编号：ISO 11608-1:2022
中文名称：医用针基注射系统 要求和试验方法 第1部分：针基注射系统
英文名称：Needle-based injection systems for medical use — Requirements and test methods — Part 1: Needle-based injection systems
发布日期：2022-04
标准范围
This document specifies requirements and test methods for Needle-Based Injection Systems (NISs) for single-patient use intended to deliver discrete volumes (bolus) of medicinal product, which can be delivered through needles or soft cannulas for intradermal, subcutaneous and/or intramuscular delivery, incorporating pre-filled or user-filled, replaceable or non-replaceable containers.
This document applies in cases where the NIS incorporates a prefilled syringe. However, stand-alone prefilled syringes defined by ISO 11040-8 are not covered by this document (see exclusions below).
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