本文件规定了单个患者使用的体上给药系统（OBDS）针头注射系统（NISs）的要求和试验方法，该系统旨在通过针头或软套管，通过皮下、肌肉内或皮内给药，包括预填充或用户填充、可更换或不可更换的容器。 注1？虽然从技术上讲，使用软套管的设备不是“基于针的”，但软套管是由针放置的，可以包括在该分类中。 注2？ISO？11608？系列的其他部分已经制定并包括了一些要求和方法。 本文件不包括设计用于以特定速率连续输送以达到和/或维持所需血浆药物浓度的输液泵。然而，虽然本文件不打算直接适用于这些泵产品，但它确实包含可用于帮助设计和评估它们的要求和测试方法。 注3:IEC 60601-2-24（如果是电子版）或ISO 28620（如果是非电子版）对其进行了说明。

This document specifies requirements and test methods for On-Body Delivery Systems (OBDS) needle-based injection systems (NISs) for single patient use, intended for subcutaneous, intramuscular or intradermal delivery of a discrete volume (bolus) of medicinal product, through needles or soft cannulas, incorporating pre-filled or user-filled, replaceable or non-replaceable containers. NOTE 1？Although technically a device using a soft cannula is not “needle-based”, the soft cannula is placed by a needle and can be included in this classification. NOTE 2？Some requirements and methods are already established and included in other parts of the ISO？11608？series. Infusion pumps that are designed for continuous delivery at a specific rate required to achieve and/or maintain a desired plasma medicinal product concentration are excluded from this document. However, while this document is not intended to directly apply to these pump products, it does contain requirements and test methods that can be used to help design and evaluate them. NOTE 3 They are covered by IEC 60601-2-24 (if electronic) or ISO 28620 (if non-electronic).