Recognized standard
15026-2 First edition 2011-02-15
FDA recognition 13-87 · ISO · Software/Informatics
Key facts
| Recognition number | 13-87 |
|---|---|
| Designation | 15026-2 First edition 2011-02-15 |
| Title | Systems and software engineering - Systems and software assurance - Part 2: Assurance case |
| Standards developer | International Organization for Standardization |
| Specialty area | Software/Informatics |
| Date of entry | Dec 23, 2016 |
| Scope (excerpt) | This part of ISO/IEC 15026 specifies minimum requirements for the structure and contents of an assurance case. An assurance case includes a top-level claim for a property of a system or product (or set of claims), systematic argumentation regarding this claim, and the evidence and explicit… |
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: