Recognized standard
F3293-18
FDA recognition 14-517 · ASTM · Sterility
Key facts
| Recognition number | 14-517 |
|---|---|
| Designation | F3293-18 |
| Title | Standard Guide for Application of Test Soils for the Validation of Cleaning Methods for Reusable Medical Devices |
| Standards developer | ASTM International |
| Specialty area | Sterility |
| Date of entry | Sep 17, 2018 |
| Scope (excerpt) | 1.1 This guide provides methods and considerations for simulated soiling of reusable medical devices for the purpose of validating cleaning instructions. Techniques for application of soil, as well as incorporation of soil by various means (e.g., actuation of devices) will be described in order to… |
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: