Recognized standard
SW96:2023
FDA recognition 13-131 · ANSI · Software/Informatics
Key facts
| Recognition number | 13-131 |
|---|---|
| Designation | SW96:2023 |
| Title | Standard for medical device security - Security risk management for device manufacturers |
| Standards developer | American National Standards Institute |
| Specialty area | Software/Informatics |
| Date of entry | Oct 9, 2023 |
| Scope (excerpt) | This standard provides requirements and guidance when addressing design, production and post-production security risk management for medical devices within the risk management framework defined by ISO 14971. This standard is intended to assist manufacturers and other users of the standard with the… |
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: