• Title/Summary/Keyword: 진단용방사선발생장치 검사기관

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ISO/IEC 17020 Suitability Assessment: Standard Plan for Quality Assurance System for Diagnostic Radiological Equipment Inspection Organization (ISO/IEC 17020 : 적합성 평가 - 다양한 유형의 검사기관 운영을 위한 요구사항을 반영한 진단용방사선발생장치 및 방어시설 검사 기관의 품질보증시스템 표준안 연구)

  • Jong-Nam Lee;Yong-Su Yoon;Youngjun Kim;Jung-Su Kim
    • Journal of the Korean Society of Radiology
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    • v.18 no.5
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    • pp.463-471
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    • 2024
  • Through this study, the purpose of this study is to harmonize the quality assurance system of diagnostic radiation generator inspection bodies with current international standards, standardize the diversity of inspection bodies, provide consistent inspection services to medical institutions, and improve review efficiency of regulatory agencies. We compared and reviewed the quality assurance systems of all domestic diagnostic radiation generator and defense facility inspection bodies. For international harmonization, we reviewed international and domestic and international standards, including ISO/IEC 17020, and added and reflected the requirements of regulatory agencies. The quality assurance systems of all inspection bodies included all required items in compliance with ISO/IEC 17020, but some of the quality procedures showed differences. Standards were drawn up through expert meetings for items where differences were compared and analyzed, and rules for safety management of diagnostic radiation generators and amendments to these regulations were proposed. The results of this study are expected to improve the operational efficiency of inspection bodies and the work efficiency of regulatory agencies for inspection bodies, and international harmonization in accordance with international standards such as ISO/IEC 17020 should be continuously maintained.

Problems of the Act and Subordinate Statutes Related to the Regulation of Radiation Safety for Diagnosis (진단용 방사선 안전관리 법령의 문제점에 관한 연구)

  • Lim, Chang-Seon
    • The Korean Society of Law and Medicine
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    • v.23 no.2
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    • pp.97-118
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    • 2022
  • The use of diagnostic radiation in medical institutions is rapidly increasing. Accordingly, the collective effective dose is on the rise every year. Therefore, it is necessary to reduce the radiation exposure of the person undergoing the radiation examination as low as reasonably achievable. And we must establish a legal system to perform the safe management of radiation for diagnosis efficiently. In this way, I went over the problems of the Act and Subordinate Statutes regarding radiation safety management for diagnosis. As a result, the main contents are as follows. First, in the 「Medical Service Act」, there is no basis for the Safety Inspection Institute of Radiation and Radiation Exposure Measuring Institutes. And there are no provisions concerning delegation of administrative disposition. Therefore, it is necessary to secure legal justification by providing the basis for the Safety Inspection Institute of Radiation along with Radiation Exposure Measuring Institutes and the basis for administrative dispositions against these institutions in the 「Medical Service Act」. Second, the 「Rules on the Installation and Operation of Special Medical Equipment 」 should be integrated with the 「Rules on the Safety Management of Radiation Generators for Diagnostics」 to unify administrative procedures such as reporting for radiation special medical equipment for diagnosis. Third, in the case of violating the diagnostic radiation safety management standards in the 「Rules on the Safety Management of Radiation Generators for Diagnostics」, it is necessary to supplement the insufficient sanctions such as administrative disposition. Fourth, regulating diagnostic radiation and therapeutic radiation used in medical institutions with the dual legal system of the 「Medical Act」 and the 「Nuclear Safety Act」 is not efficient in the safety management of diagnostic radiation. Therefore, it is necessary to uniformly regulate diagnostic radiation and all medical radiation, including therapeutic radiation and nuclear medicine, in the 「Medical Service Act」 system.

A Study on the Management of Exposure of Workers and Assistants Related to Diagnostic Radiation (진단용 방사선 관련 업무 종사자의 피폭관리에 관한 연구)

  • Lim, Chang-Seon
    • The Korean Society of Law and Medicine
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    • v.22 no.3
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    • pp.97-124
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    • 2021
  • In medical institutions, there are radiation-related workers such as radiological technologists, physicians, dentists, and dental hygienists who handle diagnostic radiation generators. Also, there are work assistants, such as nurses and assistant nurses, who assist in radiation treatment or transfer patients to the radiation examination room. Radiation exposure management for radiation-related workers is carried out under the 「Medical Service Act」, but there is no legal basis for work assistants, etc. And the management of radiation exposure for diagnosis is regulated by the 「Medical Service Act」, and the management of radiation exposure by therapeutic radiation and nuclear medical examination is governed by the 「Nuclear Safety Act」. Thus, to improve the management of radiation exposure for diagnosis, the regulations on radiation exposure management for diagnosis under the 「Medical Service Act」 were compared and reviewed with those of the 「Nuclear Safety Act」. As a result, the main contents are as follows. First, it is necessary to legislate to include nurses, assistant nurses, and clinical practice students who are likely to be exposed to radiation besides radiationrelated workers as subjects of radiation exposure management for diagnosis. Second, when a radiation-related worker for diagnosis is confirmed to be pregnant, the exposure dose limit should be defined. Third, it is necessary to revise the regulations on the types of personal exposure dosimeters in the 「Rules on the Safety Management of Radiation Generators for Diagnostics」. Fourth, it seems that health examination items for radiation-related workers, radiation workers, and frequent visitors should be the same. Fifth, It is necessary to unify and regulate diagnostic radiation and all medical radiation, including therapeutic radiation and nuclear medicine, in one legal system.

A Base Study on the Constancy Quality Control Test and Clause of Diagnosis Radiation Equipment (진단용 방사선 발생장치의 수시 정도관리 항목 및 기준에 관한 기초 연구)

  • Heo, Yeji;Kim, Kyotae;Noh, Sicheul;Nam, Sanghee;Park, Jikoon
    • Journal of the Korean Society of Radiology
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    • v.8 no.3
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    • pp.105-110
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    • 2014
  • Diagnostic radiation equipment diagnosis and treatment of disease of recent plays a central role, but this is based on the assumption of an appropriate balance of benefits and risks of diagnostic. If balance is not maintained has the potential to give an adverse effect on the health of the public. In the case of an overseas, the importance of (QA) quality assurance of medical equipment is growing, but evaluation criteria of quality assurance has not been clearly presented in domestic. Therefore, the modernization of medical equipment from the point at which the degree of cycle-by-cycle management system of foreign national to be suitable for diagnostic radiation generator entry and quality control standards by introducing a tailoring is necessary. In this study the most frequently used diagnostic radiation generator X-ray imaging apparatus of the general three-year periodic inspections at any time between the periodic inspection items and quality control methods and standards for the establishment of the United States, Canada and abroad, and international electronic literature search Technical Committee (International Electro-technical Commission, IEC) were compared with the provisions of item. Based on the national quality control items when opening frequent inspection items and standards presented as a basis for setting up study.

Convergence analysis of safety management for radiation workers and diagnostic radiation-generator devices of animal hospital in Korea (국내 동물병원의 진단용 방사선 발생장치 및 방사선 관계종사자 안전관리에 관한 융복합적 분석)

  • Kang, Kyoung-Mook;Suh, Tae-Young;Kim, Yong-Sang;Yun, Seon-Jong
    • Journal of the Korea Convergence Society
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    • v.11 no.4
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    • pp.55-61
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    • 2020
  • The various types of radiation-generator devices have been used in animal hospitals, and the safety for radiation workers is becoming important in Korea. This study investigated and analyzed the radiation safety management for diagnostic radiation-generator devices and radiation workers of animal hospital. The number of radiation-generator devices and radiation workers of animal hospital increased from 2,138 to 2,972 and from 2,644 and 5,733 for six years. The number of general X-ray, CT, C-arm, portable and dental X-ray in 2019 were 2,204, 58, 67, 770, and 14. The number of veterinarian, veterinary nurse, veterinary assistant, and others in 2019 were 4,236, 1,080, 404, and 13. The average exposure dose of radiation workers in 2018 were 0.21mSv in surface dose, 0.18mSv in depth doses. This study is expected to be the basic data for the safety management of radiation-generating devices and radiation workers in animal hospital.

A Study on the Measurement Linearity of Photoluminescent Dosimeter (형광유리선량계의 계측 직선성 연구)

  • Jeong, Kyeong-Hwan;Jung, Dong-Kyung;Seo, Jeong-Min
    • Journal of the Korean Society of Radiology
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    • v.15 no.6
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    • pp.841-847
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    • 2021
  • Related institutions that use radiation are diverse in Korea, such as research, medical care, and education. Recently, the number of examinations and visits to medical institutions is increasing. As a result, the number of radiological examinations in medical institutions is increasing. Radiation safety management is necessary as well as exposure of radiation workers. For safety management, first of all, it is necessary to wear the personal exposure dosimeter correctly and measure it accurately after wearing it. This study tries to evaluate and verify the measurement straightness of PLD devices by radiation of a diagnostic generator. Radiation division irradiation time interval was measured after irradiating 10 times at 10, 30, and 60 sec and irradiating the irradiation distance from 30 to 100 cm at 10 cm intervals to measure the change in absorbed dose depending on the distance. As a result, there was no difference in absorbed dose by time interval. This is considered to be helpful in various studies by using a diagnostic generator for the study of high absorbed dose.

The Improvement Plan on Unifying from Law and Regulations Related to Radiation (방사선관계법 개정 시 용어 적용에 관한 개선 방안)

  • Jeong, Dong-Kyong;Lee, Jong-Back;Park, Myeong-Hwan
    • The Journal of Korean Society for Radiation Therapy
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    • v.18 no.1
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    • pp.7-12
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    • 2006
  • Purpose: This is for the purpose to help the bill related to technologists be systematic and unitary by carefully analyzing a legislation, an enforcement ordinance, and enforcement regulations in the connection with the radiological worker and the radiation workers from the law and regulations related to technologists. Materials and Methods: Concerning technologists, a legislation, an enforcement ordinance, and enforcement regulations for a sort of medical technician, regarding the radiological worker, the rules of diagnosis radiation equipment safety management, and concerning the radiation workers, atomic energy law, an enforcement ordinance and enforcement regulations were gathered, compared with one another, and analyzed. Results: Among technologists, in the case of working in the department of diagnosis radiation, the title 'Radiological Worker' is used by the Medical Service Law, and in the case of working in the department of radiation tumors or the one of nucleus medicine, the title 'Radiation Workers' is used by the Atomic Energy Law. Conclusion: Besides the technical term that is used by characteristic tasks, unification of the terms that can be used in common is necessary for sure. And when a legislation, an enforcement ordinance, enforcement regulations, and notification, things like that in the radiation field are amended, certainly they should be done by mutual agreement through negotiation between the organization related to radiation and the governmental organization.

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Usability Evaluation of Gel Pad Materials for Superficial Structures used in Musculoskeletal Ultrasonography (근골격계 초음파검사에 사용되는 표재성 검사용 젤 패드 물질의 유용성 평가)

  • Han, Mi-Ran;Kwak, Jong-Gil;Song, Jong-Nam;Jang, Seong-Ju;Han, Jae-Bok
    • Journal of the Korean Society of Radiology
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    • v.15 no.6
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    • pp.899-909
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    • 2021
  • In Musculoskeletal ultrasound examination, a linear transducer (12-5 MHz) with a contact surface length of 6 cm, which is commonly distributed in medical institutions, does not contact with bent fingers and wrist depressions only by using a conventional liquid ultrasound gel, which causes image loss. In order to solve this image loss, the use of commercially available Water gel pad is increasing. However, it is a disposable medical product. Repeated use is prohibited and expensive. In this study, in order to reduce the economic burden caused by the use of the commercialized Water gel Pad, we searched for water-soluble food thickener powder that can be easily purchased around our lives and manufactured Gel pads. Among them, kappa-Carrageenan Gel Pad, iota-Carrageenan Gel Pad, and Agar-Agar Gel Pad satisfied the evaluation criteria without artifacts in image evaluation using the N-365 Multipurpose Phantom. Also, the price to purchase the food thickener powder was about 38 times cheaper than the existing commercialized Water gel pad. As a result, if you use the food thickener powder such as kappa-Carrageenan, iota-Carrageenan and Agar-Agar to make solidified elastic Gel pad without a cover instead of the commercially available expensive disposable Water gel pad, the convenience and usefulness of use are improved. It is judged that the manufactured Gel pads can contribute well to the role of efficient ultrasound propagation medium.

Radiation Exposure Dose on Persons Engaged in Radiation-related Industries in Korea (한국에서 방사선 관련 종사자들의 개인피폭선량 실태에 관한 연구)

  • Lim, Bong-Sik
    • Journal of radiological science and technology
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    • v.29 no.3
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    • pp.185-195
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    • 2006
  • Purpose: This study investigated the status of radiation exposure doses since the establishment of the "Regulations on Safety Management of Diagnostic Radiation Generation Device" in January 6, 1995. Method: The level of radiation exposure in people engaged or having been engaged in radiation-related industries of inspection organizations, educational organizations, military units, hospitals, public health centers, businesses, research organizations or clinics over a 5 year period from Jan. 1, 2000 to Dec. 31, 2004 was measured. The 149,205 measurement data of 57,136 workers registered in a measurement organization were analysed in this study. Frequency analysis, a Chi-square test, Chi-square trend test, and ANOVA was used for data analysis. Results: Among 57,136, men were 40,870(71.5%). 50.3% of them were radiologic technologists, otherwise medical doctors(22.7%), nurse(2.9%) and others(24.1%). The average of depth radiation and surface radiation during the 5-year period were found to decrease each year. Both the depth radiation and surface radiation exposure were significantly higher in males, in older age groups, in radiological technologists of occupation. The departments of nuclear medicine had the highest exposure of both depth and surface radiation of the divisions of labor. There were 1.98 and 2.57 per 1,000 person-year were exposed more than 20 mSv(limit recommended by International Commission on Radiological Protection) in depth and surface radiation consequently. Conclusion: The total exposure per worker was siginifcantly decreased by year. But Careful awareness is needed for the workers who exposed over 20 mSv per year. In order to minimize exposure to radiation, each person engaged in a radiation-related industry must adhere to the individual safety management guidelines more thoroughly. In addition, systematic education and continuous guidance aimed at increasing the awareness of safety must be provided.

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