Recognized standard
60731 Edition 3.1 2016-04
FDA recognition 12-304 · IEC · Radiology
Key facts
| Recognition number | 12-304 |
|---|---|
| Designation | 60731 Edition 3.1 2016-04 |
| Title | Consolidated Version Medical electrical equipment - Dosimeters with ionization chambers as used in radiotherapy |
| Standards developer | International Electrotechnical Commission |
| Specialty area | Radiology |
| Date of entry | Dec 23, 2016 |
| Device classes | Class 2 |
| Scope (excerpt) | IEC 60731:2011 specifies the performance requirements of radiotherapy dosimeters, intended for the measurement of absorbed dose to water or air kerma (and their rates and spatial distributions) in photon, electron, proton or heavy ion radiation fields as used in radiotherapy. The dose monitoring… |
At a glance
- 10–99 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: