Tiêu chuẩn quốc tế

• Số hiệu / Standard Number: EN ISO 21649:2009
• Năm ban hành / Publication date: 2009
• Tình trạng / Status: A - Còn hiệu lực
• Tên tiếng Anh / Title in English: Needle-free injectors for medical use - Requirements and test methods (ISO 21649:2006)
• Phạm vi áp dụng / Scope of standard: 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.