| IEC 60976 Edition 2.0 2007-10 Medical electrical equipment - Medical electron accelators - Functional performance characteristics |
| Recognition Date | 2013-08-06 |
| Recognition List | 031 |
| Recognition Number | 12-253 |
| Extent | Complete standard |
| Standards Orgs | IEC International Electrotechnical Commission http://www.iec.ch/ |
| STG | Radiology |
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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 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 to 50 MeV at maximum ABSORBED DOSE RATES between 0,001 Gy s-1 and 1 Gy s-1 at 1 m from the RADIATION SOURCE and at NORMAL TREATMENT DISTANCES between 50 cm and 200 cm from the RADIATION SOURCE.
The present standard describes measurements and test procedures to be performed by the MANUFACTURER at the design and construction stage of a medical ELECTRON ACCELERATOR but does not specify ACCEPTANCE TESTS to be performed after installation at the purchaser's site. The accompanying report, IEC 60977, however, does suggest that many of the test procedures are appropriate for ACCEPTANCE TESTS.
The measurement conditions described in the present standard differ from those previously in use. This applies particularly to the PHANTOM position for measurements and the measurement of distances from the ISOCENTRE. These new conditions should be substituted for and not be added to previous methods.
| Regulation Number | Device Name | Device Class | Product Code |
| §892.5050 | Accelerator, Linear, Medical | Class 2 | IYE |
| There is no relevant guidance developed at this time. |