Recognized standard
62220-1-1 Edition 1.0 2015-03
FDA recognition 12-289 · IEC · Radiology
Key facts
| Recognition number | 12-289 |
|---|---|
| Designation | 62220-1-1 Edition 1.0 2015-03 |
| Title | Medical electrical equipment-Characteristics of digital X-ray imaging devices Part 1-1: Determination of the detective quantum efficiencyDetectors used in radiographic imaging |
| Standards developer | International Electrotechnical Commission |
| Specialty area | Radiology |
| Date of entry | Aug 14, 2015 |
| Device classes | Class 2 |
| Scope (excerpt) | Specifies the method for the determination of the detective quantum efficiency (DQE) of digital X-ray imaging devices as a function of exposure and of spatial frequency for the working conditions in the range of the medical application as specified by the manufacturer. Is applicable to projection… |
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: