儿科患者自我给药注射系统 设计要求和指南

[中文适用范围]： 本文件提供了针对特定人口统计学群体的儿科患者自行给药的药物输送系统开发的要求和指南，这些患者正在执行预期用途所需的部分或全部使用步骤。使用步骤包括患者收到产品后执行的任何处理操作；这些步骤包括但不限于： — 运输 – 旅行时携带产品（例如步行、火车、飞机、汽车、公共汽车）； — 储存 – 患者在使用前或使用期间在家中、学校、办公室或临时储存箱中储存产品； — 准备 – 将产品置于随时可用状态的必要步骤； — 操作 – 启动、调整、暂停、停止或以其他方式管理使用产品进行药物输送的必要步骤； — 维护 – 保持产品良好工作状态的必要步骤； — 处置 – 确保使用后安全处置产品的步骤（例如将产品放置在合适的容器中）。本文件适用于用于给药的注射药物输送系统。此外，如果其他药物输送设备或系统旨在供儿科人群使用，则本文件对它们的开发也很有用。不在本文件范围内的设备包括导管（例如 ISO 10555 系列范围内的导管）和输液泵系统（例如 IEC 60601-2-24 和气雾剂输送设备（ISO 20072））。 [外文原描述]： This document provides requirements and guidelines on the development of drug delivery systems intended for self-administration of medicinal products by the specific demographic group of paediatric patients who are performing some or all use steps required for their intended use. Use steps include any handling action performed after the patient has received the product; these can include but are not limited to: — transport – carrying the product while travelling (e.g. by walking, train, airplane, automobile, bus); — storage – storage by the patient in their home, school, office or in temporary storage cases before or between uses; — preparation – steps necessary to place the product in a state where it is ready to be administered; — operation – steps necessary to initiate, adjust, pause, stop, or otherwise manage the delivery of medication using the product; — maintenance – steps necessary to keep the product in good working order; — disposal – steps to ensure safe disposal of the product after use (e.g. placement of the product in a suitable receptacle). This document is applicable to injectable drug delivery systems for administration of medicinal products. Furthermore, this document can be useful for the development of other drug delivery devices or systems if they are intended for use by the paediatric population. Devices not in the scope of this document include catheters, for example those in the scope of ISO 10555 series, and infusion pump systems, e.g. IEC 60601-2-24 and aerosol delivery devices (ISO 20072).