Recognized standard
EP18-A2
FDA recognition 7-212 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-212 |
|---|---|
| Designation | EP18-A2 |
| Title | Risk Management Techniques to Identify and Control Laboratory Error Sources; Approved Guideline - Second Edition |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | Oct 4, 2010 |
| Scope (excerpt) | This guideline describes risk management techniques that will aid in identifying, understanding, and managing sources of failure (potential failure modes) and help to ensure correct results. Although intended primarily for in vitro diagnostics, this document will also serve as a reference for… |
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: