Recognized standard
62083 Edition 2.0 2009-09
FDA recognition 12-217 · IEC · Radiology
Key facts
| Recognition number | 12-217 |
|---|---|
| Designation | 62083 Edition 2.0 2009-09 |
| Title | Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems |
| Standards developer | International Electrotechnical Commission |
| Specialty area | Radiology |
| Date of entry | Mar 14, 2011 |
| Device classes | Class 2 |
| Scope (excerpt) | This International Standard applies to the design, manufacture and some installation aspects of a radiotherapy treatment planning systems(RTPS) - for use in RADIOTHERAPY TREATMENT PLANNING in human medical practice; - that imports data either through input by the OPERATOR or directly from other… |
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: