Recognized standard
13402 First edition 1995-08-01
FDA recognition 4-320 · ISO · Dental/ENT
Key facts
| Recognition number | 4-320 |
|---|---|
| Designation | 13402 First edition 1995-08-01 |
| Title | Surgical and dental hand instruments -- Determination of resistance against autoclaving, corrosion and thermal exposure |
| Standards developer | International Organization for Standardization |
| Specialty area | Dental/ENT |
| Date of entry | Dec 18, 2023 |
| Device classes | Class 1, Class 2 |
| Scope (excerpt) | This International Standard describes test methods to determine the resistance of stainless steel surgical and dental hand instruments against autoclaving, corrosion and thermal exposure. The requirements for such tests are defined and stated in the product standard along with the number of cycles… |
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: