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Objective:To study the testing method of quality control of digital X-ray gastrointestinal machine,so as to ensure safe and effective operation of the equipment.Methods:According to the National Health Industry Standard<Specification for Testing of Quality Control in Medical X-ray Diagnostic Equipment>(WS 76-2020),the quality control of digital X-ray machine for the stomach and intestine was tested.The multifunctional X-ray dosimeter and the corresponding phantom were adopted to detect the deviation of the tube voltage indication,the half-value layer(HVL),the Kerma rate of incident body surface air of the subjects who received fluoroscopy examination,the high-contrast resolution and other parameters of the digital X-ray gastrointestinal machine.And then,whether the testing of quality control of that complied with the requirement of national regulations were further evaluated.Results:The detection of quality control of digital X-ray gastrointestinal machine indicated that the maximum deviation values of the tube voltage indications of 81kV and 90kV were respectively 0.86%and 0.97%,and the repeatability of radiation output was 0.1%,and the HVL was 3.12mmAI,and the typical value and the maximum value of the Kerma rate of incident body surface air of the subjects who received fluoroscopy examination were respectively 5.316mGy/min and 18.63mGy/min,and the high-contrast resolution of fluoroscopy was 1.6 lp/mm,and the low-contrast resolution of fluoroscopy was 3.3%,and the vertical angle of the useful wire beam was<1.5°,and the deviations between the light field and each boundary of right,left,lower and upper boundaries of the radiation field were respectively(a1)=-0.6 cm,(a2)=-0.1 cm,(b1)=0 cm and(b2)=-0.7 cm.In addition,the horizontally and vertically relative deviations of range errors were respectively 0.3%and 0.5%.In the deviations of exposure times(t),the deviations of t=50ms and t=140ms were respectively 9.42%and 2.14%.The images did not have obvious artifact.The above results indicated that the testing of quality control of digital X-ray machine for the stomach and intestine complied with the requirement of national regulations.Conclusion:The testing of the quality control for digital X-ray gastrointestinal machine,which adopts multi-functional X-ray dosimeter and the corresponding phantom,can reflect the performance status of the equipment,and ensure the safe and effective operation of the equipment in clinical practice.
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@#<b>Objective</b> To investigate the current situation of quality control in medical linear accelerators in Hebei Province, China. <b>Methods</b> The main performance indices of some medical linear accelerators in Hebei Province, 2019—2021 were tested according to the current relevant effective standards GB 15213—2016 <i>Medical Electron Accelerators-Functional Performance Characteristics and Test Methods</i> and WS 674—2020 <i>Specification for Testing of Quality Control in Medical Linear Accelerator</i>. <b>Results</b> A total of 175 medical linear accelerators were tested from 2019 to 2021, and the annual pass rates were 72.4% in 2019, 75.9% in 2020, and 79.4% in 2021. The overall pass rate of initial inspection was 76.0%, and the pass rate of reinspection was 100.0%. The index with the lowest pass rate in the initial inspection was square X radiation field uniformity, followed by dose deviation and square X radiation field symmetry. <b>Conclusion</b> Medical institutions should strengthen quality control management, conduct regular testing of medical linear accelerators, and timely correct dose deviation, so as to ensure the treatment effect of patients.
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One of the credos for a successful product development, early clinical trial supplies, achieving full-scalemanufacturability and speed to the market is the vendor qualification. The focus of this paper is to employ a systematicapproach to qualify different active pharmaceutical ingredient (API) suppliers. In this context, API sourced from twodifferent vendors used in product development, where prototype formulations manufactured with identical componentsand specifications demonstrated significant variations in drug product performance attributable to vendor-to-vendorvariability. Prototype prepared using API (Vendor 1) showed disintegration of tablets in 4.5 minutes which compliedwith in-house specifications, whereas it was >15 minutes for the prototype prepared from API (Vendor 2). In orderto understand these differences, a vast array of solid state techniques were employed to compare the critical materialattributes of API (GDCS1902) from two different Vendors. Furthermore, these tools were orthogonally applied tounderstand whether API from two Vendors demonstrated any process-induced transformations, such as processinduced polymorphism, process-induced crystal disorder, and process-induced fragmentation. The results of thesemeasurements indicated the presence of fine particles of varied morphology with API (Vendor 1), while API (Vendor2) showed more medium-sized uniform particles. Formulation process modification to induce API fragmentation insitu was carried out for the API from Vendor 2. This modification produced desired granule properties which were thensubjected to drug performance tests and was found to match the specification. This study demonstrates the importanceof understanding the critical material attributes to match the final product performance when multiple vendors wereselected.
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Objective To promote the development of non-invasive automated sphygmomanometer (oscillometry) performance testing technology by studying the related technologies and devices.Methods The performance testing contents of noninvasive automated sphygmomanometer (oscillometry) were summarized based on data inquiry and etc,involving in static and dynamic performance testing.The technical characteristics of the blood pressure simulator for testing non-invasive automated sphygmomanometer were analyzed,and the current market situation of the blood pressure simulator was described.Results The blood pressure simulator showed problems in concept,traceability and calibration.Conclusion To develop a new generation of blood pressure simulator is the development direction of non-invasive automated sphygmomanometer (oscillometry) performance testing technology.
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The transport packages are primarily developed for transportation and storage,whose capabilities directly affect the product qualities during the circulation.During pharmaceutical development,the domestic pharmacy enterprises tend to put emphasis on the inner packing,but neglect the potential hazard elements in the distribution cycles and performance tests for transport packages of pharmaceutical products,which ultimately result in the disregard of hidden quality peril.This paper analyzes the necessity and significance ofthe performance tests for pharmaceuticals,follow by its domestic and overseas status.And then several testing standards for transport packages,especially ASTM D4169 (Standard Practice for Performance Testing of Shipping Containers and Systems),are introduced in order to provide some suggestions of the performance testing for transport packages of pharmaceutical products.
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Objective:To summarize the performance of surface contamination meters was using through applied national standard to calibrate them so as to provide helpful suggestion for radiation protection.Methods: 18 surface contamination meters were enrolled in this research. Depend on the national standard (GB/T 5202-2008/IEC 60325:2002) to implement calibration. In the calibration, two groups of241Am alpha plane source and two groups of204T1 beta plane source were chosen as standard source. The holder was used to fix the distance of measurement between source and detector, and then the efficiency of apparatus, statistical fluctuation and relative inherent error were measured depended on the standard procedure.Results: The efficiency of apparatus of 18 surface contamination meters in detection forαray mainly focused on 20%-40%, and forβ ray, it mainly focused on 20%-60%. All of statistical fluctuations of 18 meters forαray were lower than 10%, and forβ ray, there were 14 meters were lower than 10% and 4 meters focused on 10%-20%. In the measurement of relative inherent error, most of results were lower than 6%.Conclusion: The performances of 18 surface contamination meters conform with national standards, although individual indicator of individual apparatus still lower than the level of same kind of apparatus. This paper recommends paramedic should pay attention to maintain the apparatus, and ensure the normal function and measurement accuracy of apparatus so as to provide strong support for radiation protection.
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Objective To study a series of tests to the IMRT planning system RayStation,and verify the feasibility of this Standard.Referring to the standard Performance and test methods for intensity modulated radiation therapy (IMRT) treatment planning system (Standard).Methods Referring to the Standard,the tests include:dose goals used for planning,point dose calculation accuracy and dose distribution calculation accuracy.And test phantoms include:AAPM TG119 report's test cases and solid water phantom for verification,and IMRT test cases include:multitarget,mock prostate,head/neck and CTshape (easier version and harder version) and so on.Referring to the Standard,we optimize and calculate doses of interest in RayStation,and use the common measurement equipments and tools,such as an ionization chamber,films,a detector array,and etc,to measure the doses on the accelerator,then calculate and analyze the errors between them.Results The results of dose goals for five different mock plans meet the requirements of the Standard.And the point dose ionization chamber measurements are in line with the requirements of the Standard,and the total error of the mock plans was (0.83 ± 1.65) ％.The γpass rates of per-field measurements using detector array are all greater than 99.0％,and the γpass rates of composite film measurements are all greater than 92.5％.Conclusions The results of three trials to IMRT performance of RayStation are in full compliance with the requirements of the Standard.And also it is an evidence for the feasibility of this Standard.
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Objective:To evaluate the clinical performance of radiation treatment equipment inspection status of the medical and health institutions in Nanjing. Methods: Twenty-two 60Coy teletherapy machine and 12 Teclast subsidiary medical accelerator were detacted from January 2012 to December 2012 in Nanjing. Results: The performance qualified rate of 60Coy teletherapy machine is higher. In other standards, the 60Coy teletherapy machines have different degrees of failures. The performance test results of electronic medical accelerator is good, the majority of medical electronic accelerator performance can comply with the relevant national standards. Conclusion: Regular checks on the performance of radiation treatment equipment and on time check can ensure clinical efficacy and safety of patients treated with radiotherapy treatment.