Recognized standard
21649 First edition 2006-06-01
FDA recognition 6-179 · ISO · General Plastic Surgery/General Hospital
Key facts
| Recognition number | 6-179 |
|---|---|
| Designation | 21649 First edition 2006-06-01 |
| Title | Needle-free injectors for medical use -- Requirements and test methods |
| Standards developer | International Organization for Standardization |
| Specialty area | General Plastic Surgery/General Hospital |
| Date of entry | Aug 6, 2013 |
| Device classes | Class 2 |
| Scope (excerpt) | 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… |
At a glance
- 1–9 Product codes
- 1–9 FDA guidance documents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA-recognized consensus standards
The FDA recognizes voluntary consensus standards that manufacturers can cite in premarket submissions to show conformity with specific requirements.
Source: U.S. Food and Drug Administration (FDA), Recognized Consensus Standards database · Source date: