BS EN ISO 21649-2009 医用无针头式注射器.要求和试验方法

标准号：BS EN ISO 21649-2009
中文标准名称：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
标准类型：C31
发布日期：2009/11/30 12:00:00
实施日期：2009/11/30 12:00:00
中国标准分类号：C31
国际标准分类号：11.040.20
引用标准：ISO 3207-1975;ISO 3746-1995;ISO 10993;ISO 11201-1995;ISO 11202-1995;ISO 11204-1995;ISO 14155-1-2003;ISO 14155-2-2003;ISO 14253-1-1998;IEC 60068-2-27-1987;IEC 60068-2-30-2005;IEC 60068-2-32-1975;IEC 60068-2-64-1993;IEC 60601-1-1-2000;IEC 61000-4-3-2002;IEC
适用范围：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.