医用针头注射系统.要求和试验方法.第1部分:针头注射系统

[中文适用范围]： 本文件规定了供单患者使用的针式注射系统（NIS）的要求和测试方法，该系统旨在输送离散体积（推注）的药品，这些药品可以通过针头或软插管进行皮内、皮下和/或肌内注射交付，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 包含预充式注射器的情况。 但是，本文件不涵盖 ISO 11040-8 定义的独立预充式注射器（请参阅下面的排除情况）。 需要注意的是，预充式注射器的其他功能和特性，例如剂量精度，应符合 ISO 11040-8 中的要求（输送量），而不是本文件，除非添加影响输送功能（例如，机构）。 旨在限制或停止柱塞运动，从而限制输送的剂量）。 在这种情况下，该系统完全被本文件和 ISO 11608 系列的适用要求所覆盖。 不包括在范围内的是： ——ISO 11040-8 定义的独立预充式注射器（除上述例外情况外）； ——提供连续输送并要求药品标签中临床指定的输送速率或由医生根据临床相关性（即药物功效）确定的输送速率的 NIS，与胰岛素贴片泵或传统输液泵的情况一样（例如 IEC 60601- 2-24， — 具有可多次再填充的容器的 NIS； ——与用户填充容器相关的方法或设备的要求，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）； ——用于牙科用途的 NIS； ——用于不同给药途径（例如静脉内、鞘内、眼内）的 NIS。 注：排除的这些产品可能会受益于本文件中的要素，但可能无法完全满足基本安全性和有效性此类产品。 [外文原描述]： 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.