標準號：BS EN ISO 21649-2009
中文標準名稱：醫用無針頭式注射器.要求和試驗方法
英文標準名稱：Needle-free injectors for medical use - Requirements and test methods
標準類型：C31
發布日期：2009/11/30 12:00:00
實施日期：2009/11/30 12:00:00
中國標準分類號：C31
國際標準分類號：11.040.20
引用標準：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
適用范圍：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.