IEC 60601-2-68 Edition 1.0 2014-09

Medical Electrical Equipment - Part 2-68: Particular Requirements For The Basic Safety And Essential Performance Of X-ray-based Image-guided Radiotherapy Equipment For Use With Electron Accelerators, Light Ion Beam Therapy Equipment And Radionuclide

60601-2-68 Edition 1.0 2014-09

Standard Organization: IEC

IEC 60601-2-68 Edition 1.0 2014-09
Medical electrical equipment - Part 2-68: Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment

Recognition NumberRadiology
Recognition Date2018-09-17
Recognition List050
Recognition Number12-319
Extent Complete standard
Standards Orgs IEC International Electrotechnical Commission http://www.iec.ch/
STG Radiology
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Rationale:

This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.

Scope:

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of X-ray based IMAGE-GUIDED RADIOTHERAPY equipment for use with EXTERNAL BEAM EQUIPMENT (EBE). This particular standard covers safety aspects of kilovoltage (kV) and megavoltage (MV) X-ray imaging devices in a known geometrical relationship with EBE for the purpose of IGRT. It covers aspects of communication and relationships between the EXTERNAL BEAM EQUIPMENT and X-ray imaging devices, attached or not directly attached to, but in the same RADIATION shielded area as, and dedicated for use only with, the EXTERNAL BEAM EQUIPMENT. This particular standard deals with equipment for REAL-TIME X-IGRT, ONLINE X-IGRT and OFFLINE X-IGRT. It covers procedures to reduce the risk of over-reliance on the X-IGRT EXTERNAL BEAM SYSTEM (X-IGRT EBS). For example the manufacturer will provide an interactive interface for user interaction with the correction suggested by the system.

Code of Federal Regulations:

Regulation Number Device Name Device Class Product Code
§892.5750 System, Radiation Therapy, Radionuclide Class 2 IWB
§892.5050 Accelerator, Linear, Medical Class 2 IYE
§892.5050 System, Radiation Therapy, Charged-Particle, Medical Class 2 LHN

FDA Guidance:

There is no relevant guidance published at this time.


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