Recognized standard
TR 63183 Edition 1.0 2019-12
FDA recognition 12-333 · IEC · Radiology
Key facts
| Recognition number | 12-333 |
|---|---|
| Designation | TR 63183 Edition 1.0 2019-12 |
| Title | Guidance on error and warning messages for software used in radiotherapy |
| Standards developer | International Electrotechnical Commission |
| Specialty area | Radiology |
| Date of entry | Jul 6, 2020 |
| Scope (excerpt) | This document, which is a Technical Report, provides guidance on the usage and form of error or warning messages written for software used in RADIOTHERAPY. It does not replace any requirements existing in the safety standards but is meant to be used as a supplement to existing standards on usability… |
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: