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DEVELOPMENT OF SOFTWARE CALCULATION
FOR RADIATION LEAK ACCORDING TO ISO
IEC 60601-1-3
C.E.B. Queiroz*, W.G.Junior**,T.R.Janh**, T.T. Hahn**, N.K.P.Lima***
*Federal University of Santa Catarina
Department of Physics; Campus - Trindade - Florianópolis-SC
ZIP Code 88040 -900; carlosqueiroz@live.com
**Brasilrad Medical Physics and Radiation Protection; professor hermínio Jacques,166,Florianópolis-SC
***Federal University of Santa Catarina; Campus - Trindade - Florianópolis-SC ZIP Code 88040 -900
The average deviation between the values ​​obtained by the software and
the values ​​calculated using the spreadsheets were below 1%, in addition,
the software could calculate the uncertainties in the measurement with a
very simple form, where the user only enters values components of
uncertainty and result in histogram and displayed as shown in Figure 1.
With a simple interface, the program Xprotec was created to provide an
important tool for evaluating the leakage radiation in x-ray equipment x
References
ANVISA, 1998. Portaria/MS/SVS nº 453,Vigilância Sanitária,
Ministério da Saúde, Brasilia.
IEC,2008. IEC 60601-1-3 Medical Electrical Equipment - Part 1-3:
General Requirements for Basic Safety and Essential Performance -
Collateral Standard: Radiation Protection in Diagnostic X-Ray
Equipment, IEC, Geneva.
BIPM, IEC, IFCC,ILAC, ISO, IUPAC, IUPAP, OIML, 2008. Evaluation
of measurement data — Supplement 1 to the “Guide to the expression
of uncertainty in measurement” — Propagation of distributions using a
Monte Carlo method, first ed. JCGM, France.
Abstract
Radiation leakage is defined as the radiation that can penetrate the
printhead and / or collimation system, not belonging to the primary
beam. Also known as radiation leak (ANVISA, 1998). In this work, we
developed a software which estimates the radiation leak in x-ray tubes
according to the recommendations of IEC 60601-1-3 - Medical
electrical equipment Part 1-3: General requirements for basic safety and
essential performance - collateral standard: Radiation protection in
diagnostic x-ray equipment.
Introduction
In Brazil the measurement of radiation leakage is a mandatory item in
accepting a x-ray equipment in a radiology service, Ordinance 453/1998
of the National Health Surveillance Agency (ANVISA) defines the
limits of acceptability and frequency of tests radiation leak, however it
does not specify the method of calculation to be used for evaluation of
radiation leakage. In order to facilitate the assessment of the radiation
leak software called Xprotec was created based on the recommendations
of IEC 60601-1-3 using the compiler embarcadero Delphi ® 2010 and
Microsoft Access database. It was built to help medical physicists and
weatherman to estimate the radiation leak and error analysis of the
measurements through histograms of probability distributions.
Measurement uncertainties are calculated by the Monte Carlo method as
described in ISO GUM Supplement 1 (BIMP et al, 2008).
Materials and methods
In order to validate the use of software, it was tested to evaluate two x-
ray equipment General Electric brand, with x-ray tube Varian Model
RAD-12. The measurements were performed with the radiation monitor
brand Radcal Model 2026C and with an ionization chamber model
20X6 with 1800cm ³. Measurements were made at a distance of 1m
from the focal point of the equipment and with the longest exposure
possible. Altogether, there were 6 points around the dome of x-rays
were taken and grades of 4 measurements for each value selected point.
For the validation of the software calculations we used Microsoft Excel
spreadsheets.
Results and Conclusion
Table 1 and 2 show the results of the validation to the respective
measuring points. A total of M = 106 iterations were used and the
coverage probability of 95.45% for the analysis of measurement
uncertainty.
Figure 1 - The software form
Table 1 Results obtained for equipment 1
Table 2 Results obtained for equipment 2
* A - Collimator,B - Right Side,C - above,D - Left Side,E - Front e F - Behind
Position Air
kerma
(nGy)
Nominal
voltage
(kVp)
Nominal
current (mA)
Nominal
time (s)
Potency
(W)
Leakage
Radiation
Software
(mGy h-1)
Leakage
Radiation
Excel
(mGy h-1)
A* 30,1 125 250 1,5 870 0,00198~0,00201 0,002±0,05
B* 15,5 125 250 1,5 870 0,00098~0,00100 0,001±0,05
C* 20,7 125 250 1,5 870 0,00110~0,00113 0,001±0,05
D* 32,2 125 250 1,5 870 0,00210~0,00212 0,002±0,05
E* 25,9 125 250 1,5 870 0,00165~0,00167 0,001±0,05
F* 37,0 125 250 1,5 870 0,00245~0,00247 0,002±0,05
Position Air
kerma
(nGy)
Nominal
voltage
(kVp)
Nominal
current (mA)
Nominal
time (s)
Potency (W) Leakage
Radiation
Software
(mGy h-1)
Leakage
Radiation
Excel
(mGy h-1)
A* 255,5 125 250 1,5 870 0,01707~0,01723 0,017±0,05
B* 31,0 125 250 1,5 870 0,00207~0,00211 0,002±0,05
C* 63,7 125 250 1,5 870 0,00425~0,00429 0,004±0,05
D* 50,2 125 250 1,5 870 0,00675~0,00674 0,007±0,05
E* 101,1 125 250 1,5 870 0,00503~0,00505 0,005±0,05
F* 75,3 125 250 1,5 870 0,00498~0,00504 0,005±0,05
* A - Collimator,B - Right Side,C - above,D - Left Side,E - Front e F - Behind

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Development of software calculation for radiation leak according to ISO IEC 60601-1-3. In

  • 1. DEVELOPMENT OF SOFTWARE CALCULATION FOR RADIATION LEAK ACCORDING TO ISO IEC 60601-1-3 C.E.B. Queiroz*, W.G.Junior**,T.R.Janh**, T.T. Hahn**, N.K.P.Lima*** *Federal University of Santa Catarina Department of Physics; Campus - Trindade - Florianópolis-SC ZIP Code 88040 -900; carlosqueiroz@live.com **Brasilrad Medical Physics and Radiation Protection; professor hermínio Jacques,166,Florianópolis-SC ***Federal University of Santa Catarina; Campus - Trindade - Florianópolis-SC ZIP Code 88040 -900 The average deviation between the values ​​obtained by the software and the values ​​calculated using the spreadsheets were below 1%, in addition, the software could calculate the uncertainties in the measurement with a very simple form, where the user only enters values components of uncertainty and result in histogram and displayed as shown in Figure 1. With a simple interface, the program Xprotec was created to provide an important tool for evaluating the leakage radiation in x-ray equipment x References ANVISA, 1998. Portaria/MS/SVS nº 453,Vigilância Sanitária, Ministério da Saúde, Brasilia. IEC,2008. IEC 60601-1-3 Medical Electrical Equipment - Part 1-3: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Radiation Protection in Diagnostic X-Ray Equipment, IEC, Geneva. BIPM, IEC, IFCC,ILAC, ISO, IUPAC, IUPAP, OIML, 2008. Evaluation of measurement data — Supplement 1 to the “Guide to the expression of uncertainty in measurement” — Propagation of distributions using a Monte Carlo method, first ed. JCGM, France. Abstract Radiation leakage is defined as the radiation that can penetrate the printhead and / or collimation system, not belonging to the primary beam. Also known as radiation leak (ANVISA, 1998). In this work, we developed a software which estimates the radiation leak in x-ray tubes according to the recommendations of IEC 60601-1-3 - Medical electrical equipment Part 1-3: General requirements for basic safety and essential performance - collateral standard: Radiation protection in diagnostic x-ray equipment. Introduction In Brazil the measurement of radiation leakage is a mandatory item in accepting a x-ray equipment in a radiology service, Ordinance 453/1998 of the National Health Surveillance Agency (ANVISA) defines the limits of acceptability and frequency of tests radiation leak, however it does not specify the method of calculation to be used for evaluation of radiation leakage. In order to facilitate the assessment of the radiation leak software called Xprotec was created based on the recommendations of IEC 60601-1-3 using the compiler embarcadero Delphi ® 2010 and Microsoft Access database. It was built to help medical physicists and weatherman to estimate the radiation leak and error analysis of the measurements through histograms of probability distributions. Measurement uncertainties are calculated by the Monte Carlo method as described in ISO GUM Supplement 1 (BIMP et al, 2008). Materials and methods In order to validate the use of software, it was tested to evaluate two x- ray equipment General Electric brand, with x-ray tube Varian Model RAD-12. The measurements were performed with the radiation monitor brand Radcal Model 2026C and with an ionization chamber model 20X6 with 1800cm ³. Measurements were made at a distance of 1m from the focal point of the equipment and with the longest exposure possible. Altogether, there were 6 points around the dome of x-rays were taken and grades of 4 measurements for each value selected point. For the validation of the software calculations we used Microsoft Excel spreadsheets. Results and Conclusion Table 1 and 2 show the results of the validation to the respective measuring points. A total of M = 106 iterations were used and the coverage probability of 95.45% for the analysis of measurement uncertainty. Figure 1 - The software form Table 1 Results obtained for equipment 1 Table 2 Results obtained for equipment 2 * A - Collimator,B - Right Side,C - above,D - Left Side,E - Front e F - Behind Position Air kerma (nGy) Nominal voltage (kVp) Nominal current (mA) Nominal time (s) Potency (W) Leakage Radiation Software (mGy h-1) Leakage Radiation Excel (mGy h-1) A* 30,1 125 250 1,5 870 0,00198~0,00201 0,002±0,05 B* 15,5 125 250 1,5 870 0,00098~0,00100 0,001±0,05 C* 20,7 125 250 1,5 870 0,00110~0,00113 0,001±0,05 D* 32,2 125 250 1,5 870 0,00210~0,00212 0,002±0,05 E* 25,9 125 250 1,5 870 0,00165~0,00167 0,001±0,05 F* 37,0 125 250 1,5 870 0,00245~0,00247 0,002±0,05 Position Air kerma (nGy) Nominal voltage (kVp) Nominal current (mA) Nominal time (s) Potency (W) Leakage Radiation Software (mGy h-1) Leakage Radiation Excel (mGy h-1) A* 255,5 125 250 1,5 870 0,01707~0,01723 0,017±0,05 B* 31,0 125 250 1,5 870 0,00207~0,00211 0,002±0,05 C* 63,7 125 250 1,5 870 0,00425~0,00429 0,004±0,05 D* 50,2 125 250 1,5 870 0,00675~0,00674 0,007±0,05 E* 101,1 125 250 1,5 870 0,00503~0,00505 0,005±0,05 F* 75,3 125 250 1,5 870 0,00498~0,00504 0,005±0,05 * A - Collimator,B - Right Side,C - above,D - Left Side,E - Front e F - Behind