• Title/Summary/Keyword: Diagnostic Radiation Equipment

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General Requirements Pertaining to Radiation Protection in Diagnostic X-ray Equipment -KFDA DRS 1-1-3 : 2008 base on IEC 60601-1-3:2008- (진단용 엑스선 장치에 있어서 방사선 방어에 대한 일반 요구사항 -IEC 60601-1-3:2008에 근거한 KFDA DRS 1-1-3:2008-)

  • Kang, Hee-Doo;Dong, Kyung-Rae;Kweon, Dae-Cheol;Choi, Jun-Gu;Jeong, Jae-Ho;Jung, Jae-Eun;Ryu, Young-Hwan
    • Korean Journal of Digital Imaging in Medicine
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    • v.11 no.2
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    • pp.69-77
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    • 2009
  • This study gives an account of the collateral standards in IEC 60601-1-3: 2008 specifying the general requirements for basic safety and essential performance of diagnostic X-ray equipment regarding radiation protection as it pertains to the production of X-rays. The collateral standards establish general requirements for safety regarding ionization radiation in diagnostic radiation systems and describe a verifiable evaluation method of suitable requirements regarding control over the lowest possible dose equivalent for patients, radiologic technologists, and others. The particular standards for each equipment can be determined by the general requirements in the collateral standard and the particular standard is followed in the risk management file. The guidelines for radiation safety of diagnostic radiation systems is written up in ISO 13485, ISO 14971, IEC 60601-1-3(2002)1st edition, medical electric equipment part 1-3, and the general requirements for safety-collateral standards: programmable electrical medical systems. Therefore the diagnostic radiation system protects citizens' health rights with the establishment and revisions of laws and standards for diagnostic radiation systems as a background for the general requirements of radiation safe guards applies, as an international trend, standards regarding the medical radiation safety management. The diagnostic radiation system will also assure competitive power through a conforming evaluation unifying the differing standards, technical specifications, and recognized processes.

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Analysis of Radiation Exposure Dose according to Location Change during Radiation Irradiation

  • Chang-Ho Cho;Jeong-Lae Kim
    • International Journal of Advanced Culture Technology
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    • v.12 no.2
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    • pp.368-374
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    • 2024
  • During an X-ray examination, the beam of radiation is dispersed in many directions. We believe that managing radiation dose is about providing transparency to users and patients in the accurate investigation and analysis of radiation dose. The purpose of measuring the radiation dose as a function of location is to ensure that medical personnel using the equipment or participating in the operating room are minimally harmed by the different radiation doses depending on their location. Four mobile diagnostic X-ray units were used to analyze the radiation dose depending on the spatial location. The image intensifier and the flat panel detector type that receives the image analyzed the dose by angle to measure the distribution of the exposure dose by location. The radiation equipment used was composed of four units, and measuring devices were installed according to the location. The X-ray (C-arm) was measured by varying the position from 0 to 360 degrees, and the highest dose was measured at the center position based on the abdominal position, and the highest dose was measured at the 90° position for the head position when using the image intensifier equipment. The operator or medical staff can see that the radiation dose varies depending on the position of the diagnostic radiation generator. In the image intensifier and flat panel detector type that accepts images, the dose by angle was analyzed for the distribution of exposed dose by position, and the measurement method should be changed according to the provision of dose information that is different from the dose output from the equipment according to the position.

The Recent Trend of the National and International Standard of Manufacturing Quality Control for Diagnostic X-ray Equipment (진단용엑스선장치 제조품질관리에 관한 국내.외 규격의 동향)

  • Choi, In-Seok;Kim, Jung-Min;Jeong, Hoi-Woun;Min, Jung-Whan;Lee, In-Su
    • Journal of radiological science and technology
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    • v.32 no.1
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    • pp.1-15
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    • 2009
  • Newly published IEC 60601-1-3 ; 2008 2nd Edition has two important meanings. First, Radiation Quality and Dose should make sure for safety of patient and staff in manufacturing diagnostic X-ray equipment. Second, it should be minimized of Leakage Radiation, Residual Radiation, and Stray Radiation. The requirement to make enactment or revision of national standard for diagnostic X-ray Equipment is as follows : 1. It should be adjusted the new standard to the recent IEC Publication under the consideration of the Korea medical circumstances. 2. For focus to the Radiation Safety, IEC 60601-1-3 (General requirements for radiation protection in diagnostic X-ray equipment) could be applied to the new regulation. It should be compact sentence. 3. A sudden Notification change should not be desired. It needs a enough time to make easy the circumstances.

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Amendment of the Inspection Standard for Diagnostic Radiation Equipment Applying 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 (KS C IEC60601-1-3: 의료용 전기기기-제1-3부: 기본 안전 및 필수 성능에 관한 일반 요구사항-보조표준: 진단용 X선 장치의 방사선 방어를 적용한 진단용 방사선 발생장치의 검사기준 개선안)

  • Park, Hye-Min;Kim, Jung-Min;Kim, Jung-Su;Kim, Seong-Ok;Choi, Young-Min
    • Journal of radiological science and technology
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    • v.41 no.5
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    • pp.493-504
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    • 2018
  • The diagnostic radiation equipment is managed in accordance with the "Rules for Safety Management of Diagnostic Radiation Equipment" enacted in 1995. The equipments should be inspected before use and every three years after use in accordance with the [Appendix 1] of the same rule. The inspection standard has been maintained without particular revision since enacted. But, over the past two decades new types of equipments have been manufactured and used. So, it is necessary to revise [Appendix 1] by making inspection items and inspection standards. In this study, we revised the classification system of equipments and reviewed international standards of IEC 60601 series, IEC 61223 series and AAPM TG 18 On-line Report No.03. And identified the problem of current inspection standards. Through this, we revised, deleted and added the inspection items and inspection standard of each equipment to meet the domestic circumstances. As a result of the study, we reorganized the classification system of equipment which are current classified as 5 classes into 22 classes as X-ray system etc. (7 classes), CT system etc. (5 classes) and Dental X-ray system etc. (10 classes). And then, we developed 70 inspection items for 6 types of equipments according to the reorganized classification system of equipments. The inspection items and inspection standards derived from this study have been proposed to the KCDC and will be applied to the revision of the Rule's [Appendix 1]. Therefore, we expect to be used as reference materials for domestic medical center, inspection institutions, and equipment manufacturing import companies.

A New Radiation-Shielding Device for Restraining Veterinary Patients

  • Songyi Kim;Minju Lee;Miju Oh;Yooyoung Lee;Jiyoung Ban;Jiwoon Park;Sojin Kim;Uhjin Kim;Jaepung Han;Dongwoo Chang
    • Journal of Veterinary Clinics
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    • v.40 no.6
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    • pp.429-437
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    • 2023
  • In veterinary medicine, most radiographic images are obtained by restraining patients, inevitably exposing the restrainer to secondary scattered radiation. Radiation exposure can result in stochastic reactions such as cancer and genetic effects, as well as deterministic reactions such as skin burns, cataracts, and bone marrow suppression. Radiation-shielding equipment, including aprons, thyroid shields, eyewear, and gloves, can reduce radiation exposure. However, the risk of radiation exposure to the upper arms, face, and back remains, and lead aprons and thyroid shields are heavy, restricting movement. We designed a new radiation-shielding system and compared its shielding ability with those of conventional radiation-shielding systems. We hypothesized that the new shielding system would have a wider radiation-shielding range and similar shielding ability. The radiation exposure dose differed significantly between the conventional and new shielding systems in the forehead, chin, and bilateral upper arm areas (p < 0.001). When both systems were used together, the radiation-shielding ability was better than when only one system was used at all anatomical locations (p < 0.01). This study suggests that the new radiation-shielding system is essential and convenient for veterinary radiation workers because it is a step closer to radiation safety in veterinary radiography.

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 Electromagnetic Wave Measurement in Diagnostic Imaging Equipment (진단용 영상장치에서 전자파 측정에 관한 고찰)

  • Eo, Yun-Gi
    • Korean Journal of Digital Imaging in Medicine
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    • v.7 no.1
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    • pp.39-44
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    • 2005
  • Purpose of this research is that if Radiographer has focused on Radiation exposure research until now, he should realize that always exposed by Electro Magnetic Wave at given working environment And also, another purpose is that to minimize damage with measuring Electro Magnetic Wave which is happened area and distance of Radiation Control System and High Voltage Equipment, check occurrence rate and minimize damage from it.

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The Educational Pending Problems for the Safe Management of Diagnostic Imaging Equipment and the Current Status. (진단용 방사선 발생장치 안전관리를 위만 교육현안과 현주소)

  • Song Tea-ho;Gho Heung;Kim Myung-hoe
    • Journal of The Korean Radiological Technologist Association
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    • v.28 no.1
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    • pp.74-82
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    • 2002
  • 1. Purpose Presently, the service areas of those who we engaged in radiation works are being specialized. Thus, in this study, we propose a way for efficiently improving mutual relationship between the works of the radiation technicians(radiologists) and

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Acoustic Power Measurement System of Array Probes for Ultrasonic Diagnostic Equipment Using Radiation Force Balance Methods (방사힘 측정법을 이용한 초음파 진단장치용 배열 탐침자의 음향파워 측정시스템)

  • Yun, Yong-Hyeon;Jho, Moon-Jae;Kim, Yong-Tae;Lee, Myoung-Ho
    • The Journal of the Acoustical Society of Korea
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    • v.29 no.6
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    • pp.355-364
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    • 2010
  • Considering biological safety, it is very important to measure acoustic power from ultrasonic array probe for diagnostic ultrasound imaging applications. In this paper, to measure acoustic power from each element on array probe for ultrasonic diagnostic equipment, we reconstruct and automate the acoustic power measurement system. The acoustic power from linear, phased and curved array were measured and analyzed. As a result of measurement, the effects caused by directivity of sound beam from curved array were founded. To remove these effects, we developed and applied the correction model. The proposed system is useful to evaluate characteristics of the acoustical output power of array probe.

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.