Recognized standard
LIS09-A
FDA recognition 13-24 · CLSI · Software/Informatics
Key facts
| Recognition number | 13-24 |
|---|---|
| Designation | LIS09-A |
| Title | Standard Guide for Coordination of Clinical Laboratory Services within the Electronic Health Record Environment and Networked Architectures |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | Software/Informatics |
| Date of entry | Sep 9, 2008 |
| Device classes | Class 1 |
| Scope (excerpt) | This guide covers the process of defining and documenting the capabilities, sources, and pathways of data exchange within a given network architecture of a Health Information Network (HIN) serving a set of constituents. |
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: