ISO 21649:2006 医用无针头注射器-要求和试验方法

标准编号：ISO 21649:2006

中文名称：医用无针头注射器-要求和试验方法

英文名称：Needle-free injectors for medical use — Requirements and test methods

发布日期：2006-06

标准范围

ISO 21649:2006适用于临床和其他医疗环境中供人使用以及患者个人使用的一次性和多用途无针注射系统的安全性、性能和测试要求。注射系统的剂量室通常是一次性的，可在一次性使用或有限次数使用后更换。它有时与注射机构分离，通常被称为“药筒”、“安瓿”、“注射器”、“胶囊”或“圆盘”。相比之下，剂量室也可以是一个永久性的内部室，其设计可以持续到设备的声称寿命。

ISO 21649:2006 applies to safety and performance and testing requirements for single-use and multiple-use needle-free injection systems intended for human use in clinics and other medical settings and for personal use by patients.The dose chamber of the injection system 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 also may be a permanent internal chamber designed to last through the claimed life of the device.

标准预览图