Recognized standard
60601-2-28 Edition 3.0 2017-06
FDA recognition 12-309 · IEC · Radiology
Key facts
| Recognition number | 12-309 |
|---|---|
| Designation | 60601-2-28 Edition 3.0 2017-06 |
| Title | Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis |
| Standards developer | International Electrotechnical Commission |
| Specialty area | Radiology |
| Date of entry | Dec 23, 2019 |
| Device classes | Class 1 |
| Scope (excerpt) | This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of X-RAY TUBE ASSEMBLIES and to components thereof, intended for medical diagnosis and imaging. Where the general standard IEC 60601-1 and the collateral standard IEC 60601-1-3 refer to ME EQUIPMENT, this is interpreted as… |
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: