Recognized standard
60806 Edition 2.0 2022-11
FDA recognition 12-350 · IEC · Radiology
Key facts
| Recognition number | 12-350 |
|---|---|
| Designation | 60806 Edition 2.0 2022-11 |
| Title | Determination of the maximum symmetrical radiation field of X-ray tube assemblies and X-ray source assemblies for medical diagnosis |
| Standards developer | International Electrotechnical Commission |
| Specialty area | Radiology |
| Date of entry | May 29, 2023 |
| Device classes | Class 1 |
| Scope (excerpt) | This document is applicable to X-RAY SOURCE ASSEMBLIES and X-RAY TUBE ASSEMBLIES. NOTE 1 If, for certain MEDICAL ELECTRICAL SYSTEMS, special radiation fields are required such that the scope of IEC 60806 does not apply (e. g., using CT collimators with bow-tie filters), the appropriate system… |
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: