Recognized standard
F1089-18
FDA recognition 8-478 · ASTM · Materials
Key facts
| Recognition number | 8-478 |
|---|---|
| Designation | F1089-18 |
| Title | Standard Test Method for Corrosion of Surgical Instruments |
| Standards developer | ASTM International |
| Specialty area | Materials |
| Date of entry | Sep 17, 2018 |
| Device classes | Class 1, Class 2 |
| Scope (excerpt) | 1.1 This test method covers general test procedures and evaluation criteria for the corrosion resistance of new and reusable surgical instruments fabricated from stainless steel alloys, such as, but not limited to, those listed in Specification F899. 1.2 Instruments containing stainless steel… |
At a glance
- 10–99 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: