The IEC 60601-2-1 standard prepared by the International Electrotechnical Commission (IEC), an affiliate of the International Organization for Standardization (ISO), criteria for basic safety and performance of electron accelerator devices in the range of 1 to 50 MeV (million electronvolts) used for the treatment of patients explains.
This standard has been published in our country by the Turkish Standards Institute with the following title: TS EN 60601-2-1 Electrical medical equipment - Part 2-1: Special rules for the basic safety and required performance of electron accelerators in the 1 Mev - 50 Mev range.
This standard explains the requirements that manufacturing companies must comply with in the design and production of electron accelerator devices used in radiotherapy. However, this standard does not define the optimum performance requirements of the device. It only sets limits against degradation of the device's performance. The main purpose of the standard is to define the design features required for the safe operation of such medical electrical equipment.
In the latest update of the standard, compatibility has been achieved with new technological devices such as stereotactic radiosurgery and stereotactic radiotherapy, intensity-adjusted radiotherapy, electronic imaging devices and moving beam radiotherapy used in radiotherapy.
Particle accelerator devices are devices that accelerate charged elementary particle beams (electron, proton, etc.) to the targeted energies and desired quality. These devices use electromagnetic fields to raise charged particles to high speeds and keep them together in bunches. Particle accelerator devices are generally used in cancer diseases.
IEC 60601-2A few standards that have been referred to during the implementation of the -1 standard and are indispensable are: IEC / TR 60788 (medical electrical equipment, defined glossary) and IEC 61217 (radiotherapy devices, coordinates, movements and scales).
Tests in accordance with IEC 60601-2-1 standard are also carried out by our organization within the scope of medical device tests.
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