BS EN ISO 21649:2009

BS EN ISO 21649:2009 BS EN ISO 21649:2009 Needle-free injectors for medical use. Requirements and test methods
BS EN ISO 21649 is the British Standard applicable 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. BS EN ISO 21649 applies to needle-free injectors primarily intended to administer medicinal products to humans. Because of the anticipated variation in the designs of such a broad array of devices, this BS EN ISO 21649 is promulgated more as a “horizontal” rather than a “vertical” one. Thus, it will tend to specify the results of the design effort instead of the physical and construction requirements used as the basis for device design, so that innovation in achieving the intended purposes is not unnecessarily restricted. Standards of this nature intentionally avoid addressing more than the most basic elements regarding the safety and performance of needle-free injector devices in humans. Any intended labelling of such devices indicating their use to deliver medicinal products into the body or into specified tissue compartments thereof (e.g., intramuscular, subcutaneous or intradermal), or for the administration of specific pharmaceutical drugs or vaccines, shall fall under the authority of national governments or supranational agencies regulating the manufacture and marketing of me...