Recognized standard
LIS03-A
FDA recognition 13-18 · CLSI · Software/Informatics
Key facts
| Recognition number | 13-18 |
|---|---|
| Designation | LIS03-A |
| Title | Standard Guide for Selection of a Clinical Laboratory Information Management System |
| 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 selection, purchase, use, enhancement, and updating of computer technology supplied by a vendor as a complete system in the clinical laboratory. The purpose of the guide is to assist hospitals, clinics, and independent laboratories through the entire automation project in order… |
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: