Recognized standard
60601-2-29 Edition 3.0 2008-06
FDA recognition 12-211 · IEC · Radiology
Key facts
| Recognition number | 12-211 |
|---|---|
| Designation | 60601-2-29 Edition 3.0 2008-06 |
| Title | Medical electrical equipment - Part 2-29: Particular requirements for the basic safety and essential performance of radiotherapy simulators |
| Standards developer | International Electrotechnical Commission |
| Specialty area | Radiology |
| Date of entry | Aug 6, 2013 |
| Device classes | Class 2 |
| Scope (excerpt) | This Particular Standard applies to RADIOTHERAPY SIMULATORS: - that use diagnostic X-RAY EQUIPMENT to simulate physically a RADIOTHERAPY RADIATION BEAM, so that the TREATMENT VOLUME to be subjected to IRRADIATION during RADIOTHERAPY can be localized, and the position and of the RADIOTHERAPY… |
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: