Recognized standard
62563-2 Edition 1.0 2021-11
FDA recognition 12-344 · IEC · Radiology
Key facts
| Recognition number | 12-344 |
|---|---|
| Designation | 62563-2 Edition 1.0 2021-11 |
| Title | Medical electrical equipment - Medical image display systems - Part 2: Acceptance and constancy tests for medical image displays |
| Standards developer | International Electrotechnical Commission |
| Specialty area | Radiology |
| Date of entry | May 30, 2022 |
| Device classes | Class 2 |
| Scope (excerpt) | This part of IEC 62563 establishes the performance CRITERIA and test frequencies for the ACCEPTANCE TESTS and CONSTANCY TESTS. The evaluation methods are defined in IEC 62563-1. The scope of this document is directed to practical tests that can be visually evaluated or measured using basic 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: