Recognized standard
62464-1 Edition 2.0 2018-12
FDA recognition 12-332 · IEC · Radiology
Key facts
| Recognition number | 12-332 |
|---|---|
| Designation | 62464-1 Edition 2.0 2018-12 |
| Title | Magnetic resonance equipment for medical imaging Part 1: Determination of essential image quality parameters. |
| Standards developer | International Electrotechnical Commission |
| Specialty area | Radiology |
| Date of entry | Jul 6, 2020 |
| Device classes | Class 2 |
| Scope (excerpt) | This part of IEC 62464 specifies measurement procedures for the determination of many essential image quality parameters for MR EQUIPMENT. Measurement procedures as addressed in this document are suitable for - quality assessment in the ACCEPTANCE TEST, and - quality assurance in the CONSTANCY TEST… |
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: