Recognized standard
14971 Third Edition 2019-12 14971: 2019
FDA recognition 5-125 · ISO · General I (QS/RM)
Key facts
| Recognition number | 5-125 |
|---|---|
| Designation | 14971 Third Edition 2019-12 14971: 2019 |
| Title | Medical devices - Application of risk management to medical devices Medical devices - Applications of risk management to medical devices |
| Standards developer | International Organization for Standardization |
| Specialty area | General I (QS/RM) |
| Date of entry | Dec 23, 2019 |
| Scope (excerpt) | This International Standard specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls… |
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: