Recognized standard
60336 Edition 5.0 2020-12
FDA recognition 12-335 · IEC · Radiology
Key facts
| Recognition number | 12-335 |
|---|---|
| Designation | 60336 Edition 5.0 2020-12 |
| Title | Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Focal spot dimensions and related characteristics |
| Standards developer | International Electrotechnical Commission |
| Specialty area | Radiology |
| Date of entry | Jun 7, 2021 |
| Scope (excerpt) | This document applies to FOCAL SPOTS in medical diagnostic X-RAY TUBE ASSEMBLIES for medical use, operating at X-RAY TUBE VOLTAGES up to and including 150 kV. This document describes the test methods employing digital detectors for determining: a) FOCAL SPOT dimensions in terms of NOMINAL FOCAL SPOT… |
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: