Recognized standard
F3357-19
FDA recognition 14-538 · ASTM · Sterility
Key facts
| Recognition number | 14-538 |
|---|---|
| Designation | F3357-19 |
| Title | Standard Guide for Designing Reusable Medical Devices for Cleanability |
| Standards developer | ASTM International |
| Specialty area | Sterility |
| Date of entry | Dec 23, 2019 |
| Scope (excerpt) | 1.1 This guide is intended to provide manufacturers of reusable medical devices design feature guidance to minimize debris retention after use and increase ease of removal of contaminants and cleaning product residuals from devices during cleaning/rinsing and also prepare for subsequent processing… |
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: