| ISO 21649 First edition 2006-06-01 Needle-free injectors for medical use -- Requirements and test methods |
| Recognition Date | 2013-08-06 |
| Recognition List | 031 |
| Recognition Number | 6-179 |
| Extent | Complete standard |
| Standards Orgs | ISO International Organization for Standardization https://www.iso.org/ |
| STG | General Plastic Surgery/General Hospital |
| FDA Tech | Keith Marin FDA/OMPT/CDRH/ODE/DAGID/GHDB/ 301-796-2462 keith.marin@fda.hhs.gov |
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
ISO 21649:2006 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.
| Regulation Number | Device Name | Device Class | Product Code |
| §880.5430 | Injector, Fluid, Non-Electrically Powered | Class 2 | KZE |
| Guidance on the Content of Premarket Notification {510(k)} Submissions for Piston Syringes, Issued April 1993 |