Hello there.
I I find myself in some methodological contradiction. I have radiotherapy device, which complains to IEC 60601-2-8.
In cl.201.10.1.2.101 I have requirements and methods to test limitation of leakage radiation from x-ray tube assembly during the treatment.
For my device specification, it should be measured at 1 m distance from the reference centre and should be less, than 1 mGy/hour. Tests for this cl. are Ok, device passed.
In cl.201.10.1.2.104 I have requirements and methods to test limitation of radiation from parts, other than tube assembly.
It should be measured at 50 mm distance from the surface of any possible part of device, except x-ray tube assembly, the least favourable case preffered, radiation leakage should be less, than 0,02 mGy/hour.
For my device it is possible to get an overlap between these requirements, because a sphere with a radius of 1 m for cl.201.10.1.2.101 can cover the body of the device from which the leakage is to be measured for cl.201.10.1.2.104.
Also, it is unclear, how to measure leakage according to cl.201.10.1.2.104, where the sensor (ionization chamber for dosimeter) should be pointed at during the test, should we additionally shield the x-ray tube assembly during the test, as we try to measure leakage from the device parts, not fromn the x-ray tube.
I'd like to get any clarification about this from Elsmar experts, as both my test lab and our country certified test lab have little experience with x-ray therapy devices.
I I find myself in some methodological contradiction. I have radiotherapy device, which complains to IEC 60601-2-8.
In cl.201.10.1.2.101 I have requirements and methods to test limitation of leakage radiation from x-ray tube assembly during the treatment.
For my device specification, it should be measured at 1 m distance from the reference centre and should be less, than 1 mGy/hour. Tests for this cl. are Ok, device passed.
In cl.201.10.1.2.104 I have requirements and methods to test limitation of radiation from parts, other than tube assembly.
It should be measured at 50 mm distance from the surface of any possible part of device, except x-ray tube assembly, the least favourable case preffered, radiation leakage should be less, than 0,02 mGy/hour.
For my device it is possible to get an overlap between these requirements, because a sphere with a radius of 1 m for cl.201.10.1.2.101 can cover the body of the device from which the leakage is to be measured for cl.201.10.1.2.104.
Also, it is unclear, how to measure leakage according to cl.201.10.1.2.104, where the sensor (ionization chamber for dosimeter) should be pointed at during the test, should we additionally shield the x-ray tube assembly during the test, as we try to measure leakage from the device parts, not fromn the x-ray tube.
I'd like to get any clarification about this from Elsmar experts, as both my test lab and our country certified test lab have little experience with x-ray therapy devices.