Recognized standard
ST65:2008/(R)2018
FDA recognition 14-286 · ANSI · Sterility
Key facts
| Recognition number | 14-286 |
|---|---|
| Designation | ST65:2008/(R)2018 |
| Title | Processing of reusable surgical textiles for use in health care facilities |
| Standards developer | American National Standards Institute |
| Specialty area | Sterility |
| Date of entry | Jul 9, 2014 |
| Device classes | Class 2, Class 1 |
| Scope (excerpt) | This recommended practice provides guidelines for the proper handling, processing, and preparation of reusable surgical textiles either on-site or off-site for use in health care facilities. This recommended practice specifically addresses design criteria for functional work areas; staff… |
At a glance
- 1–9 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: