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，该系统旨在交付离散体积（丸）的药物产品，可以通过针或软套管进行皮内、皮下和/或肌肉内交付，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包含预填充注射器的情况。然而，ISO 11040-8定义的独立预填充注射器不包括在本文件中（见以下除外条款）。 需要注意的是，预填充注射器的其他功能和特性，如剂量精度，取决于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，旨在限制或停止柱塞移动的机制，这将限制输送剂量）。 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。

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.