| IEC 62667 Edition 1.0 2017-08 Medical electrical equipment - Medical light ion beam equipment - Performance characteristics |
| Recognition Number | Radiology |
| Recognition Date | 2018-09-17 |
| Recognition List | 050 |
| Recognition Number | 12-320 |
| 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 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 test procedures to be performed by the MANUFACTURER of LIGHT ION BEAM ME EQUIPMENT but does not specify ACCEPTANCE TESTS.
This document specifies test procedures for the determination and disclosure of performance characteristics, knowledge of which is necessary for proper selection, application, and use of LIGHT ION BEAM ME EQUIPMENT and which are to be declared in the ACCOMPANYING DOCUMENTATION together with the greatest deviation or variation to be expected under specific conditions in NORMAL USE. A format for presentation of performance values is given in Annex A.
| Regulation Number | Device Name | Device Class | Product Code |
| §892.5050 | System, Radiation Therapy, Charged-Particle, Medical | Class 2 | LHN |
| There is no relevant guidance published at this time. |