首页 馆藏资源 舆情信息 标准服务 科研活动 关于我们
作废 EN ISO 21649:2009
到馆阅读
收藏跟踪
购买正版
Needle-free injectors for medical use - Requirements and test methods (ISO 21649:2006) 无针注射器用于医疗用途 - 要求和测试方法(ISO 21649:2006)
发布日期: 2009-09-23
实施日期: 2009-09-23
ISO 21649:2006适用于一次性和多次使用的无针注射系统的安全性能和性能和测试要求,用于诊断和其他医疗环境以及患者个人使用。 注射系统的剂量室通4568常是一次性的,并且意图在单次使4568用或有限数量的使用后更换。它有时可以与注4568射机构4568分离,通常称为“药筒”,“安瓿”,“注射器”,“胶囊”或“盘”。相比之下,4568剂量室也可以是设计成持续通过设备要求保护的寿命的永久内部室
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.
分类信息
关联关系
研制信息
归口单位: CEN/SS S03-
相似标准/计划/法规