Recognized standard
60627 Edition 3.0 2013-07
FDA recognition 12-365 · IEC · Radiology
Key facts
| Recognition number | 12-365 |
|---|---|
| Designation | 60627 Edition 3.0 2013-07 |
| Title | Diagnostic X-ray imaging equipment - Characteristics of general purpose and mammographic anti-scatter grids |
| Standards developer | International Electrotechnical Commission |
| Specialty area | Radiology |
| Date of entry | Dec 23, 2024 |
| Device classes | Class 2, Class 3 |
| Scope (excerpt) | This International Standard is applicable to ANTI-SCATTER GRIDS used in medical diagnostic Xray imaging equipment. ANTI-SCATTER GRIDS are used to reduce the incidence of SCATTERED RADIATION, produced particularly in the body of the PATIENT, upon the IMAGE RECEPTION AREA and thus to improve 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: