Recognized standard
F3321-19
FDA recognition 8-531 · ASTM · Materials
Key facts
| Recognition number | 8-531 |
|---|---|
| Designation | F3321-19 |
| Title | Standard Guide for Methods of Extraction of Test Soils for the Validation of Cleaning Methods for Reusable Medical Devices |
| Standards developer | ASTM International |
| Specialty area | Materials |
| Date of entry | Jul 6, 2020 |
| Scope (excerpt) | 1.1 This guide provides methods and considerations for extracting test soil(s) from reusable medical device(s) that occurs during simulated use validation, clinical use of the device(s) and after the device(s) have been through a cleaning process. 1.2 This is a part of a series of ASTM guides for… |
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: