Recognized standard
62563-1 Edition 1.2 2021-07 CONSOLIDATED VERSION
FDA recognition 12-341 · IEC · Radiology
Key facts
| Recognition number | 12-341 |
|---|---|
| Designation | 62563-1 Edition 1.2 2021-07 CONSOLIDATED VERSION |
| Title | Medical electrical equipment - Medical image display systems - Part 1: Evaluation methods |
| Standards developer | International Electrotechnical Commission |
| Specialty area | Radiology |
| Date of entry | Dec 20, 2021 |
| Scope (excerpt) | This part of IEC 62563 describes the evaluation methods for testing medical IMAGE DISPLAY SYSTEMS. The scope of this International Standard is directed to practical tests that can be visually evaluated or measured using basic test equipment. More advanced or more quantitative measurements can be… |
At a glance
- None 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: