Recognized standard
62220-1-3 Edition 1.0 2008-06
FDA recognition 12-214 · IEC · Radiology
Key facts
| Recognition number | 12-214 |
|---|---|
| Designation | 62220-1-3 Edition 1.0 2008-06 |
| Title | Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1-3: Determination of the detective quantum efficiency - Detectors used in dynamic imaging |
| Standards developer | International Electrotechnical Commission |
| Specialty area | Radiology |
| Date of entry | Oct 4, 2010 |
| Device classes | Class 2 |
| Scope (excerpt) | This part of IEC 62220 specifies the method for the determination of the DETECTIVE QUANTUM EFFICIENCY (DQE) of DIGITAL X-RAY IMAGING DEVICES as a function of AIR KERMA and of SPATIAL FREQUENCY for the working conditions in the range of the medical application as specified by the MANUFACTURER. The… |
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: