Recognized standard
ST77:2013/(R)2018
FDA recognition 14-396 · ANSI · Sterility
Key facts
| Recognition number | 14-396 |
|---|---|
| Designation | ST77:2013/(R)2018 |
| Title | Containment devices for reusable medical device sterilization |
| Standards developer | American National Standards Institute |
| Specialty area | Sterility |
| Date of entry | Jan 14, 2019 |
| Device classes | Class 2 |
| Scope (excerpt) | This standard covers minimum labeling and performance requirements for rigid sterilization container systems and for instrument organizers. |
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: