Recognized standard
61223-3-7 Edition 1.0 2021-12
FDA recognition 12-345 · IEC · Radiology
Key facts
| Recognition number | 12-345 |
|---|---|
| Designation | 61223-3-7 Edition 1.0 2021-12 |
| Title | Evaluation and routine testing in medical imaging departments - Part 3-7: Acceptance and constancy tests - Imaging performance of X-ray equipment for dental cone beam computed tomography |
| Standards developer | International Electrotechnical Commission |
| Specialty area | Radiology |
| Date of entry | May 30, 2022 |
| Device classes | Class 2 |
| Scope (excerpt) | This part of IEC 61223 applies to DENTAL CONE-BEAM COMPUTED TOMOGRAPHY X-RAY EQUIPMENT, hereafter also called DENTAL CBCT EQUIPMENT, that conforms to IEC 60601-2-63:2012+AMD1:2017+AMD2:2021. This document applies to ACCEPTANCE TESTS and CONSTANCY TESTS on DENTAL CONE-BEAM COMPUTED TOMOGRAPHY X-RAY… |
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: