Recognized standard
60601-2-45 Edition 3.1 2015
FDA recognition 12-294 · IEC · Radiology
Key facts
| Recognition number | 12-294 |
|---|---|
| Designation | 60601-2-45 Edition 3.1 2015 |
| Title | Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices |
| Standards developer | International Electrotechnical Commission |
| Specialty area | Radiology |
| Date of entry | Jun 27, 2016 |
| Device classes | Class 2 |
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: