Recognized standard
F2063-18
FDA recognition 8-480 · ASTM · Materials
Key facts
| Recognition number | 8-480 |
|---|---|
| Designation | F2063-18 |
| Title | Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants |
| Standards developer | ASTM International |
| Specialty area | Materials |
| Date of entry | Dec 23, 2019 |
| Scope (excerpt) | 1.1 This specification covers the chemical, physical, mechanical, and metallurgical requirements for wrought nickel-titanium bar, flat rolled products, and tubes containing nominally 54.5- to 57.0-weight percent nickel and used for the manufacture of medical devices and surgical implants. 1.2… |
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: