Recognized standard
F2633-19
FDA recognition 8-529 · ASTM · Materials
Key facts
| Recognition number | 8-529 |
|---|---|
| Designation | F2633-19 |
| Title | Standard Specification for Wrought Seamless Nickel-Titanium Shape Memory Alloy Tube for Medical Devices and Surgical Implants |
| Standards developer | ASTM International |
| Specialty area | Materials |
| Date of entry | Jul 6, 2020 |
| Scope (excerpt) | 1.1 This specification covers the requirements for wrought nickel-titanium shape memory alloy tube, nominally 54.5 to 57.0 mass/mass (weight) % nickel, in the superelastic condition, used for the manufacture of medical devices and surgical implants. Material shall conform to the applicable… |
At a glance
- None 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: