Recognized standard
60976 Edition 2.0 2007-10
FDA recognition 12-253 · IEC · Radiology
Key facts
| Recognition number | 12-253 |
|---|---|
| Designation | 60976 Edition 2.0 2007-10 |
| Title | Medical electrical equipment - Medical electron accelerators - Functional performance characteristics |
| Standards developer | International Electrotechnical Commission |
| Specialty area | Radiology |
| Date of entry | Aug 6, 2013 |
| Device classes | Class 2 |
| Scope (excerpt) | This International Standard applies to medical ELECTRON ACCELERATORS when used, for therapy purposes, in human medical practice. This standard applies to medical ELECTRON ACCELERATORS which deliver a RADIATION BEAM of either X-RADIATION or ELECTRON RADIATION with NOMINAL ENERGIES in the range 1 MeV… |
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: