Recognized standard
15459-2 Third edition 2015-03-01
FDA recognition 13-99 · ISO · Software/Informatics
Key facts
| Recognition number | 13-99 |
|---|---|
| Designation | 15459-2 Third edition 2015-03-01 |
| Title | Information technology - Automatic identification and data capture techniques - Unique identification - Part 2: Registration procedures |
| Standards developer | International Organization for Standardization |
| Specialty area | Software/Informatics |
| Date of entry | Dec 4, 2017 |
| Scope (excerpt) | This part of ISO/IEC 15459 specifies the procedural requirements to maintain identities and outlines the obligations of the Registration Authority. This part of ISO/IEC 15459 excludes those entities where ISO has designated Maintenance Agencies or Registration Authorities to provide identity and/or… |
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: