JIS T 60601-2-65:2019 医用電気機器―第２－６５部：歯科口内法用Ｘ線装置の基礎安全及び基本性能に関する個別要求事項 | ページ 7

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T 60601-2-65 : 2019 (IEC 60601-2-65 : 2012,Amd.1 : 2017)
        処理用電子機器へ
        (例 コンピュータ)
                電源から
           A 関連機器(例 電子式X線受像器)
          B X線発生装置
          C 制御盤
          D X線源装置
          E  指示用コーン(照射野限定器を含む。)
          F  モノブロック形装置
                              図BB.2−歯科口内法用X線装置の部品

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                                             T 60601-2-65 : 2019 (IEC 60601-2-65 : 2012,Amd.1 : 2017)
                                          参考文献
[1] IPSM 64:1991,Data for estimating x-ray tube total filtration
[2] GIBBS, S.J. Effective dose equivalent and effective dose: Comparison for common projections in oral and
    maxillofacial radiology. Oral Surgery, Oral Medicine, Oral Pathology, Oral Radiology, and Endodontics,
    (2000), 90 (4), pp. 538-545
[3] GIBBS, S.J., PUJOL Jr., A., CHEN, T.S., JAMES Jr., A., Patient risk from intraoral dental radiography.
    Dentomaxillofacial Radiology, (1988), 17 (1), pp. 15-23
[4] GIBBS, S.J., PUJOL Jr., A., CHEN, T.S., CARLTON, J.C., DOSMANN, M.A., MALCOLM, A.W., JAMES Jr.,
    A.E., Radiation doses to sensitive organs from intraoral dental radiography. Dentomaxillofacial Radiology,
    (1987), 16 (2), pp. 67-77
[5] GIBBS, S.J. Biological effects of radiation from dental radiography. Council on Dental Materials, Instruments,
    and Equipment. (1982)   he Journal of the American Dental Association, 105 (2), pp. 275-281
[6] UNDERHILL, T.E., CHILVARQUER, I., KIMURA, K., LANGLAIS, R.P., Mcdavid, W.D., PREECE, J.W.,
    BARNWELL, G. Radiobiologic risk estimation from dental radiology. Part I. Absorbed doses to critical organs.
    Oral Surgery, Oral Medicine, Oral Pathology, (1988), 66 (1), pp. 111-120
[7] UNDERHILL, T.E., KIMURA, K., CHILVARQUER, I., Mcdavid, W.D., LANGLAIS, R.P., PREECE, J.W.,
    BARNWELL, G. Radiobiologic risk estimation from dental radiology. Part II. Cancer incidence and fatality.
    Oral Surgery, Oral Medicine, Oral Pathology, (1988), 66 (2), pp. 261-267
[8] BRAND, J.W., GIBBS, S.J., EDWARDS, M., KATZ, J.O., LURIE, A.G., WHITE, S.C. Radiation Protection in
    Dentistry. (2003)   CRP. Report No. 145
[9] BERKHOUT, E., SANDERINK, G., VAN DER STELT, P. Digital intra-oral radiography in dentistry.
    Diagnostic efficacy and dose considerations. Oral Radiology, (2003), 19 (1), pp. 1-13
[10] FARMAN, A.G. Fundamentals of image acquisition and processing in the digital era. Orthodontics &
    craniofacial research, (2003), 6, Suppl 1, pp. 17-22
[11] FARMAN, A.G. Standards for intraoral radiographic imaging. Dentomaxillofacial Radiology, (2000), 29 (5), pp.
    257-259
[12] FARMAN, T.T., VANDRE, R.H., PAJAK, J.C., MILLER, S.R., LEMPICKI, A., FARMAN, A.G. Effects of
    scintillator on the detective quantum efficiency (DQE)   f a digital imaging system. Oral Surgery, Oral
    Medicine, Oral Pathology, Oral Radiology and Endodontology, (2006), 101 (2), pp. 219-223
[13] SONES, R.A., BARNES, G.T. A method to measure the MTF of digital x-ray systems. Medical Physics, (1984),
    11 (2), pp. 166-171.
[14] MCDAVID, W.D., WELANDER, U., SANDERINK, G.C.H., DOVE, S.B., TRONJE, G. A simple method for
    measuring MTF in direct digital intraoral radiography. Technical note. Oral Surgery, Oral Medicine, Oral
    Pathology, (1994), 78 (6), pp. 802-805
[15] FARMAN A and FARMAN T.T. A comparison of 18 different x-ray detectors currently used in dentistry. Oral
    Surgery, Oral Medicine, Oral Pathology, (2005), 99(4):485-489
[16] MONDOU, D., BONNET, E., COUDERT, J.-L., JOURLIN, M., MOLTENI, R., PACHOD, V. Criteria for the
    assessment of intrinsic performances of digital radiographic intraoral sensors. Academic Radiology, (1996), 3

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    (9), pp. 751-757
[17] WELANDER, U., MCDAVID, W.D., SANDERINK, G.C.H., TRONJE, G., MRNER, A.- C., DOVE, S.B.
    Resolution as defined by line spread and modulation transfer functions for four digital intraoral radiographic
    systems. Oral Surgery, Oral Medicine, Oral Pathology, (1994), 78 (1), pp. 109-115
[18] YOSHIURA, K., STAMATAKIS, H.C., WELANDER, U., Mcdavid, W.D., SHI, X.-Q., BAN, S., KAWAZU, T.,
    TATSUMI, M., KANDA, S. Physical evaluation of a system for direct digital intra-oral radiography based on a
    charge-coupled device. Dentomaxillofacial Radiology, (1999), 28 (5), pp. 277-283
[19] WELANDER, U., Mcdavid, W.D., MRNER, A.-C., TRONJE, G., TOKUOKA, O., FUCHIHATA, H.,
    NELVIG, P., DOVE, S.B. Absolute measures of image quality for the Sens-A-Ray direct digital intraoral
    radiography system. Oral Surgery, Oral Medicine, Oral Pathology, Oral Radiology and Endodontics, (1995),
    80 (3), pp. 345-350
[20] WELANDER, U., NELVIG, P., TRONJE, G., Mcdavid, W.D., DOVE, S.B., MORNER -, A.C., CEDERLUND,
    T. Basic technical properties of a system for direct acquisition of digital intraoral radiographs. Oral Surgery
    Oral Medicine and Oral Pathology, (1993), 75 (4), pp. 506-516
[21] LI, G., YOSHIURA, K., SHI, X.-Q., WELANDER, U., MCDAVID, W.D. Physical properties of a system for
    direct acquisition of digital intraoral radiographs. Oral Radiology, (2003), 19 (1), pp. 22-27
[22] HAYAKAWA, Y., FARMAN, A.G., SCARFE, W.C., KUROYANAGI, K., RUMACK, P.M., SCHICK, D.B.
    Optimum exposure ranges for computed dental radiography. Dentomaxillofacial Radiology, (1996), 25 (2), pp.
    71-75
[23] MOLTENI, R. Direct digital dental x-ray imaging with Visualix/VIXA. Oral Surgery Oral Medicine and Oral
    Pathology, (1993), 76 (2), pp. 235-243
[24] MOLTENI, R. An improved mode to display images from a digital X-ray sensor. Dentomaxillofacial Radiology,
    (1995), 24 (2), pp. 96-97
[25] WELANDER, U., YOSHIURA, K., LI, G., SLLSTRM, P., MCDAVID, W.D. Correction for attenuation and
    visual response in digital radiography. Dentomaxillofacial Radiology, (2002), 31 (2), pp. 117-125
[26] DOVE, S.B., Mcdavid, W.D., MAKINGS, S., Mcnally, M., WILCOX, C.D. Image compression for direct
    digital intraoral radiography. Dentomaxillofacial Radiology, (1995), 24 (2), pp. 99-100
[27] WELANDER, U., SANDERINK, G.C.H., Mcdavid, W.D., TRONJE, G., MRNER, A.-C. Some essential
    characteristics of new systems for direct digital intra-oral radiography. Dentomaxillofacial Radiology, (1995),
    24 (2), p. 89
[28] FARMAN, A.G., FARMAN, T.T. RVG-ui: a sensor to rival direct-exposure intra-oral xray film. International
    journal of computerized dentistry, (1999), 2 (3), pp. 183-196
[29] KITAGAWA, H., SCHEETZ, J.P., FARMAN, A.G. Comparison of complementary metal oxide semiconductor
    and charge-coupled device intraoral X-ray detectors using subjective image quality. Dentomaxillofacial
    Radiology, (2003), 32 (6), pp. 408-411
[30] SANDERINK, G.C.H., HUISKENS, R., VAN DER STELT, P.F., WELANDER, U.S., STHEEMAN, S.E. Image
    quality of direct digital intraoral x-ray sensors in assessing root canal length. The RadioVisioGraphy,
    Visualix/VIXA, Sens-A-Ray, and Flash Dent systems compared with Ektaspeed films. Oral Surgery, Oral
    Medicine, Oral Pathology, (1994), 78 (1), pp. 125-132
[31] MCDAVID, W.D., WELANDER, U., PILLAI, B.K., MORRIS, C.R. The Intrex-a constantpotential x-ray unit

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    for periapical dental radiography. Oral Surgery, Oral Medicine, Oral Pathology, (1982), 53 (4), pp. 433-436
[32] JACOBSON, A., KELLY, M., FARMAN, A. Problems with measurement of X-ray exposure time on pulsed
    dental X-ray units. Dentomaxillofacial Radiology, (1990), 2 (19), p. 87
[33] ICRP PUBLICATION 103−The 2007 Recommendations of the International Commission on Radiological
    Protection. J. Valentin (editor), The International Commission on Radiological Protection
[34] ULUSU T., BODUR H., ODABAS M.E., In vitro comparison of digital and conventional bitewing radiographs
    for the detection of approximal caries in primariy teeth exposed and viewed by a new wireless handheld unit.
    Dentomaxillofacial Radiology, (2010), 39 (2): pp. 91-94
[35] JIS Z 4751-2-7:2008 診断用X線高電圧装置−安全
      注記 対応国際規格 : IEC 60601-2-7:1998,Medical electrical equipment−Part 2-7: Particular
            requirements for the safety of high-voltage generators of diagnostic X-ray generators
[36] JIS Z 4751-2-28 医用電気機器−第2-28部 : 診断用X線管装置の基礎安全及び基本性能に関する個別
    要求事項
      注記 対応国際規格 : IEC 60601-2-28,Medical electrical equipment−Part 2-28: Particular requirements
            for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis
[37] IEC 60601-2-32:1994,Medical electrical equipment−Part 2: Particular requirements for the safety of
    associated equipment of X-ray equipment
[38] JIS Z 4751-2-43 IVR用X線装置−基礎安全及び基本性能
      注記 対応国際規格 : IEC 60601-2-43,Medical electrical equipment−Part 2-43: Particular requirements
            for the basic safety and essential performance of X-ray equipment for interventional procedures
[39] JIS Z 4751-2-44 医用電気機器−第2-44部 : X線CT装置の基礎安全及び基本性能に関する個別要求
    事項
      注記 対応国際規格 : IEC 60601-2-44,Medical electrical equipment−Part 2-44: Particular requirements
            for the basic safety and essential performance of X-ray equipment for computed tomography
[40] JIS Z 4751-2-45 医用電気機器−第2-45部 : 乳房用X線装置及び乳房撮影定位装置の基礎安全及び基
    本性能に関する個別要求事項
      注記 対応国際規格 : IEC 60601-2-45,Medical electrical equipment−Part 2-45: Particular requirements
            for basic safety and essential performance of mammographic X-ray equipment and mammomagraphic
            stereotactic devices
[41] JIS Z 4751-2-54 医用電気機器−第2-54部 : 撮影・透視用X線装置の基礎安全及び基本性能に関する
    個別要求事項
      注記 対応国際規格 : IEC 60601-2-54,Medical electrical equipment−Part 2-54: Particular requirements
            for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
[42] JIS T 60601-2-63 医用電気機器−第2-63部 : 歯科口外法用X線装置の基礎安全及び基本性能に関す
    る個別要求事項
      注記 対応国際規格 : IEC 60601-2-63,Medical electrical equipment−Part 2-63: Particular requirements
            for the basic safety and essential performance of dental extra-oral X-ray equipment
[43] JIS T 60601-1-8 医用電気機器−第1-8部 : 基礎安全及び基本性能に関する一般要求事項−副通則 : 
    医用電気機器及び医用電気システムのアラームシステムに関する一般要求事項,試験方法及び適用指
    針

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T 60601-2-65 : 2019 (IEC 60601-2-65 : 2012,Amd.1 : 2017)
      注記 対応国際規格 : IEC 60601-1-8,Medical electrical equipment−Part 1-8: General requirements for
            basic safety and essential performance−Collateral Standard: General requirements, tests and
            guidance for alarm systems in medical electrical equipment and medical electrical systems
[44] IEC 60601-1-10,Medical electrical equipment−Part 1-10: General requirements for basic safety and essential
    performance−Collateral Standard: Requirements for the development of physiologic closed-loop controllers
[45] IEC 60601-1-11,Medical electrical equipment−Part 1-11: General requirements for basic safety and essential
    performance−Collateral standard: Requirements for medical electrical equipment and medical electrical
    systems used in the home healthcare environment
[46] IEC 60601-1-12, Medical electrical equipment−Part 1-12: General requirements for basic safety and essential
    performance−Collateral Standard: Requirements for medical electrical equipment and medical electrical
    systems used in the emergency medical services environment

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