ISO 11608-1:2022 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

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

本文件规定了单个患者使用的针基注射系统（NISs）的要求和测试方法，该系统用于输送离散体积（丸）的药物，可通过针头或软套管进行皮内、皮下和/或肌肉内输送，包括预填充或用户填充、可更换或不可更换的容器。本文件适用于NIS包含预填充注射器的情况。然而，ISO？11040-8定义的独立预充式注射器不在本文件的涵盖范围内（见下文的除外条款）。需要注意的是，预充式注射器的其他功能和特性，如剂量精度，应符合ISO？11040中的要求（交付量）-8而不是本文件，除非添加影响输送功能（例如，旨在限制或停止柱塞移动的机制，这将限制输送的剂量）。在这种情况下，本文件和ISO？11608系列的适用要求完全涵盖了该系统。不在该范围内的有:-？ISO？11040-8规定的独立预充式注射器（上述例外情况除外）；-？提供连续输送且需要药物标签中临床规定的输送率或由医生根据临床相关性（即药物疗效）确定的输送率的NIS，如胰岛素贴片泵或传统输液泵（即。g、 IEC？60601-2-24，ISO？28620）与药品（如胰岛素）的连续输送有关；-？NISs的容器可以多次重新填充；-？与用户填充容器相关的方法或设备相关的要求，除非它们是专用附件（主要功能所需的组件，无论是否包含在原始配套产品中）；-？用于牙科的NISs；-？NISs用于不同的给药途径（例如静脉注射、鞘内注射、眼内注射）。注？这些被排除在外的产品可能受益于本文件中的元素，但可能无法完全满足此类产品的基本安全性和有效性。

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).It is important to note that other functions and characteristics of the prefilled syringe, such as dose accuracy, are subject to the requirements (delivered volume) in ISO 11040-8 and not this document, unless the addition impacts the delivery function (e.g. a mechanism that intends to restrict or stop the plunger movement, which would limit the dose delivered). In that case, the system is completely covered by this document and applicable requirements of the ISO 11608 series.Excluded from the scope are:—    stand-alone prefilled syringes defined by ISO 11040-8 (with noted exceptions above);—    NISs that provide continuous delivery and require a delivery rate clinically specified in the medicinal product labelling or determined by a physician based on clinical relevance (i.e. medication efficacy) as would be the case with insulin patch pumps or traditional infusion pumps (e.g. IEC 60601-2-24, ISO 28620) associated with continuous delivery of medicinal products (e.g. insulin);—    NISs with containers that can be refilled multiple times;—    requirements relating to methods or equipment associated with user filling of containers unless they are dedicated accessories (a component necessary for primary function, whether included in the original kitted product or not);—    NISs intended for dental use;—    NISs intended for different routes of administration (e.g. intravenous, intrathecal, intraocular).NOTE       These products that are excluded might benefit from elements in this document but might not completely fulfil the basic safety and effectiveness of such products.

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