Recognized standard
62667 Edition 1.0 2017-08
FDA recognition 12-320 · IEC · Radiology
Key facts
| Recognition number | 12-320 |
|---|---|
| Designation | 62667 Edition 1.0 2017-08 |
| Title | Medical electrical equipment - Medical light ion beam equipment - Performance characteristics |
| Standards developer | International Electrotechnical Commission |
| Specialty area | Radiology |
| Date of entry | Sep 17, 2018 |
| Device classes | Class 2 |
| Scope (excerpt) | This document applies to LIGHT ION BEAM ME EQUIPMENT when used, for therapy purposes, in human medical practice. This document applies to LIGHT ION BEAM ME EQUIPMENT which delivers LIGHT ION BEAMS with an ENERGY PER NUCLEON in the range 10 MeV/n to 500 MeV/n. This document describes measurements and… |
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: