EVS-EN ISO 21649:2009

This International Standard applies to safety and performance and testing requirements for single-use andmultiple-use needle-free injection systems intended for human use in clinics and other medical settings andfor personal use by patients.The dose chamber of the injection system is often disposable and intended to be replaced after either a singleuse 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 permanentinternal chamber designed to last through the claimed life of the device.