标题: BS EN ISO 21649-2009 医用无针头式注射器.要求和试验方法 [打印本页] 作者: sigh007 时间: 2012-3-16 18:43:27 标题: BS EN ISO 21649-2009 医用无针头式注射器.要求和试验方法
【英文标准名称】: Needle-free injectors for medical use - Requirements and test methods 【原文标准名称】: 医用无针头式注射器.要求和试验方法 【标准号】: BS EN ISO 21649-2009 【标准状态】: 现行 【国别】: 英国 【发布日期】: 2009-11-30 【实施或试行日期】: 2009-11-30【发布单位】: 英国标准学会(GB-BSI)【起草单位】: BSI【标准类型】: ()【标准水平】: ()【中文主题词】: 定义;可处置的;可处置物;药品管理;一次性使用设备;注射器械;注射;喷射器;检验;使用说明;标志;测量不确定度;医疗器械;医疗设备;医疗产品;医学科学;重新使用;规范(验收);测试;测试条件【英文主题词】: Definitions;Disposable;Disposables;Drug administration;Equipment for single use;Injection instruments;Injections;Injectors;Inspection;Instructions for use;Marking;Measuring incertainity;Medical devices;Medical equipment;Medical products;Medical sciences;Reuse;Specification (approval);Testing;Testing conditions【摘要】: This International Standard 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.Excluded from this International Standard are drug delivery methods which:- involve penetration of a part of the device itself into or through skin or mucous membranes (such asneedles, 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 passivediffusion 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.【中国标准分类号】: C31【国际标准分类号】: 11_040_20【页数】: 44P.;A4【正文语种】: 英语