Recognized standard
1998 Third Edition 2013
FDA recognition 13-65 · UL · Software/Informatics
Key facts
| Recognition number | 13-65 |
|---|---|
| Designation | 1998 Third Edition 2013 |
| Title | Standards for Safety Software in Programmable Components, Second Edition. [This Standard contains revisions through and including October 28, 2008] |
| Standards developer | Underwriters Laboratories, Inc. |
| Specialty area | Software/Informatics |
| Date of entry | Jul 9, 2014 |
| Scope (excerpt) | 1.1 These requirements apply to non-networked embedded software residing in programmable components performing safety-related functions whose failure is capable of resulting in a risk of fire, electric shock, or injury to persons. 1.2 This is a reference standard in which the requirements are to be… |
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: