Recognized standard
60812 Edition 3.0 2018-08
FDA recognition 5-120 · IEC · General I (QS/RM)
Key facts
| Recognition number | 5-120 |
|---|---|
| Designation | 60812 Edition 3.0 2018-08 |
| Title | Analysis techniques for system reliability - Procedure for failure mode and effects analysis (FMEA) |
| Standards developer | International Electrotechnical Commission |
| Specialty area | General I (QS/RM) |
| Date of entry | Jan 14, 2019 |
| Scope (excerpt) | This document explains how failure modes and effects analysis (FMEA), including the failure modes, effects and criticality analysis (FMECA) variant, is planned, performed, documented and maintained. The purpose of failure modes and effects analysis (FMEA) is to establish how items or processes might… |
At a glance
- None Product codes
- 1–9 FDA guidance documents
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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: