| IEC 60601-2-29 Edition 3.0 2008-06 Medical electrical equipment - Part 2-29: Particular requirements for the basic safety and essential performance of radiotherapy simulators |
| Recognition Date | 2013-08-06 |
| Recognition List | 031 |
| Recognition Number | 12-211 |
| Extent | Complete standard |
| Standards Orgs | IEC International Electrotechnical Commission http://www.iec.ch/ |
| STG | Radiology |
| FDA Tech | John Chen FDA/OMPT/CDRH/OIR/DRH/NMRT/ 301-796-6540 john.chen@fda.hhs.gov |
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
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 RADIATION FIELD can be confirmed;
- intended exciusively for RADIOTHERAPY simulation as a prelude to intended RADIOTHERAPY, and not for any other purpose such as general diagnostic examinations;
- used within the environmental and electrical supply conditions SPECIFIED in the technical description;
- comprising the following parts:
a system for producing an X-RAY BEAM, which simulates the geometry of the RADIOTHERAPY RADIATION BEAM;
a system for producing images of the transmitted X-RAY BEAM, for example, either by RADIOGRAPHY or RADIOSCOPY;
an assembly to control the and position of the RADIATION BEAM and to delineate the intended treatment area;
a mechanical structure that physically simulates the geometry and movements of the RADIOTHERAPY EQUIPMENT and supports the imaging system;
a PATIENT SUPPORT system
| Regulation Number | Device Name | Device Class | Product Code |
| §892.5840 | System, Simulation, Radiation Therapy | Class 2 | KPQ |
| There is no relevant guidance developed at this time. |