医用非针头式注射器.要求和试验方法

[中文适用范围]： 本文件适用于供诊所和其他医疗环境中人类使用以及供患者个人使用的一次性和多次使用无针注射系统 (NFIS) 的安全性、性能和测试要求。NFIS 的剂量室通常是一次性的，旨在在单次使用或有限次数后更换。它有时可与注射机构分离，通常称为“药筒”、“安瓿”、“注射器”、“胶囊”或“圆盘”。相反，剂量室还可以包含一个永久性内室，设计为在器械的要求寿命内持续使用，以及一个或多个消除交叉污染风险的附加部件。本文件不包括以下药物输送方法： - 涉及将器械本身的一部分刺入或穿过皮肤或粘膜（如针头、尖头、微针、植入式缓释药物器械）； — 产生气雾剂、液滴、粉末或其他剂型，用于吸入、吹入、鼻腔内或口腔沉积（如喷雾器、吸入器、喷雾器）； — 将液体、粉末或其他物质沉积在皮肤表面或粘膜表面，以便被动扩散或摄入体内（如透皮贴剂、液滴）； — 应用声能或电磁能（如超声波或离子电渗疗法设备）； — 输液系统，用于将药物添加或计量到进入体内的人造管道、导管和/或针头系统中。 [外文原描述]： This document applies to safety and performance and testing requirements for single-use and multiple-use Needle-Free Injection Systems (NFISs) intended for human use in clinics and other medical settings and for personal use by patients. The dose chamber of the NFIS is often disposable and intended to be replaced after either a single use or a limited number of uses. It is sometimes separable from the injection mechanism and often termed a “cartridge”, “ampoule”, “syringe”, “capsule” or “disc”. In contrast, the dose chamber can also incorporate a permanent internal chamber designed to last through the claimed life of the device, and an additional member or members which eliminate the risk of cross-contamination. Excluded from this document are drug delivery methods which: — involve penetration of a part of the device itself into or through skin or mucous membranes (such as needles, tines, micro-needles, implantable slow-release drug devices); — generate aerosols, droplets, powders or other formulations for inhalation, insufflation, intranasal or oral deposition (such as sprays, inhalers, misters); — deposit liquids, powders, or other substances on the surface of skin or mucosal surfaces for passive diffusion or ingestion into the body (such as transdermal patches, liquid drops); — apply sonic or electromagnetic energy (such as ultrasonic or iontophoretic devices); — infusion systems for adding or metering medication into or through systems of artificial tubes, catheters, and/or needles which themselves enter the body.