医用针头注射系统.要求和试验方法.第6部分:体内输送系统

[中文适用范围]： 本文件规定了供单个患者使用的体内输送系统（OBDS）针头注射系统（NIS）的要求和测试方法，旨在通过针头或软管将少量（大剂量）的药品输送到皮下、肌肉内或真皮内，容器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管的设备不是“基于针头的”，但软管是通过针头放置的，可以包含在此分类中。注 2 一些要求和方法已经建立并包含在输液泵的其他部分中，这些输液泵设计用于以特定速率进行连续输送，以达到和/或维持所需的血浆药品浓度，但不在本文件范围内。但是，虽然本文件并非旨在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：它们受 IEC 60601-2-24（如果是电子的）或 ISO 28620（如果是非电子的）的约束。 [外文原描述]： 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).