Recognized standard
61910-1 Edition 1.0 2014-09
FDA recognition 12-290 · IEC · Radiology
Key facts
| Recognition number | 12-290 |
|---|---|
| Designation | 61910-1 Edition 1.0 2014-09 |
| Title | Medical electrical equipment - Radiation dose documentation - Part 1: Radiation dose structured reports for radiography and radioscopy |
| Standards developer | International Electrotechnical Commission |
| Specialty area | Radiology |
| Date of entry | Aug 14, 2015 |
| Device classes | Class 2, Class 1 |
| Scope (excerpt) | IEC 61910-1:2014 applies to radiation dose structured reports produced by X ray equipment that falls within the scope of IEC 60601-2-43:2010 or IEC 60601-2-54:2009. This document does not impose specific requirements on the accuracy of the reported or displayed data. Existing standards or… |
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: