Recognized standard
61223-3-6 Edition 1.0 2020-02
FDA recognition 12-366 · IEC · Radiology
Key facts
| Recognition number | 12-366 |
|---|---|
| Designation | 61223-3-6 Edition 1.0 2020-02 |
| Title | Evaluation and routine testing in medical imaging departments - Part 3-6: Acceptance and constancy tests - Imaging performance of mammographic X-ray equipment used in a mammographic tomosynthesis mode of operation |
| Standards developer | International Electrotechnical Commission |
| Specialty area | Radiology |
| Date of entry | Dec 23, 2024 |
| Device classes | Class 2, Class 3 |
| Scope (excerpt) | This part of IEC 61223 applies to the performance of MAMMOGRAPHIC X-RAY EQUIPMENT when used in MAMMOGRAPHIC TOMOSYNTHESIS modes of operation, with respect to image quality and dose. Excluded from the scope of this document are: - MAMMOGRAPHIC X-RAY EQUIPMENT modes of operation other than… |
At a glance
- 1–9 Product codes
- 1–9 FDA guidance documents
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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: