Recognized standard
ST67:2019
FDA recognition 14-550 · ANSI · Sterility
Key facts
| Recognition number | 14-550 |
|---|---|
| Designation | ST67:2019 |
| Title | Sterilization of health care products - Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled "sterile" |
| Standards developer | American National Standards Institute |
| Specialty area | Sterility |
| Date of entry | Dec 21, 2020 |
| Scope (excerpt) | This standard specifies requirements and provides guidance on selecting approaches to establish assurance of sterility for a health care product labelled as "sterile" |
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: