JIS T 60601-2-63:2019 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 | ページ 7

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                                          参考文献
[1] WELANDER, U. A mathematical model of narrow beam rotation methods. Acta Radiologica−Series
    Diagnosis, (1974), 15 (3), pp. 305-317
[2] TRONJE, G., WELANDER, U., Mcdavid, W.D., MORRIS, C.R. Image distortion in rotational panoramic
    radiography. I. General considerations. Acta Radiologica−SerieDiagnosis, (1981), 22 (3 A), pp. 295-299
[3] TRONJE, G., WELANDER, U., MCDAVID, W.D., MORRIS, C.R. Image distortion in rotational panoramic
    radiography. III. Inclined objects. Acta Radiologica−SeriesDiagnosis, (1981), 22 (5), pp. 585-592
[4] TRONJE, G., WELANDER, U., MCDAVID, W.D., MORRIS, C.R. Image distortion in rotational panoramic
    radiography. IV. Object morphology: outer contours. (1981)   cta Radiologica−Series Diagnosis, 22 (6), pp.
    689-690
[5] MCDAVID, W.D., WELANDER, U., KANERVA, H., MORRIS, C.R. Transfer function analysis in rotational
    panoramic radiography. Acta Radiologica−Series Diagnosis, (1983) 24 (1), pp. 27-32
[6] MCDAVID, W.D., WELANDER, U., KANERVA, H., TRONJE, G., MORRIS, C.R. Definitions of unsharpness
    and layer thickness in rotational panoramic radiography. Oral Surgery, Oral Medicine, Oral Pathology, (1984),
    57 (1), pp. 96-101
[7] MCDAVID, W.D., TRONJE, G., WELANDER, U., MORRIS, C.R., NUMMIKOSKI, P. Imaging
    Characteristics of seven panoramic X-ray units. Dentomaxillofacial Radiology, Supplement, (1985), (8), pp.
    1-68
[8] SANDERINK, G.C. Imaging characteristics in rotational panoramic radiography. Dentomaxillofacial Radiology.
    Supplement, (1987), (9), pp. 1-213
[9] MCDAVID, W.D., TRONJE, G., WELANDER, U. A method to maintain a constant magnification factor
    throughout the exposure of rotational panoramic radiographs.Dentomaxillofacial Radiology, (1989), 18 (4), pp.
    160-168
[10] MCDAVID, W.D., TRONJE, G., WELANDER, U. Nonrotational scanning in panoramic radiography. Oral
    Surgery Oral Medicine and Oral Pathology, (1990), 69 (1), pp. 108-112
[11] WELANDER, U., NUMMIKOSKI, P., TRONJE, G., Mcdavid, W.D., LEGRELL, P.E., LANGLAIS, R.P.
    Standard forms of dentition and mandible for applications in rotational panoramic radiography.
    Dentomaxillofacial Radiology, (1989), 18 (2), pp. 60-67
[12] MOLTENI, R. A universal test phantom for dental panoramic radiography. MedicaMundi, (1991), 36 (3), pp.
    212-217
[13] SHIOJIMA, M., BACKSTROM, A., WELANDER, U., MCDAVID, W.D., TRONJE, G., NAITOH, M. Layer
    thickness in panoramic radiography as defined by different noiseequivalent passbands. Oral Surgery Oral
    Medicine and Oral Pathology, (1993), 76 (2),pp. 244-250
[14] ERASO, F.E., SCARFE, W.C., HAYAKAWA, Y., SMITH, M., FARMAN, A.G. Image layer characteristics of
    the PC 1000 (Mark II). Oral Radiology, (1997), 13 (1), pp. 11-21
[15] SCARFE, W.C., ERASO, F.E., FARMAN, A.G. Characteristics of the Orthopantomograph OP 100.
    Dentomaxillofacial Radiology, (1998), 27 (1), pp. 51-57
[16] MCDAVID, W.D., WELANDER, U., BRENT DOVE, S., TRONJE, G. Digital imaging in rotational panoramic

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    radiography. Dentomaxillofacial Radiology, (1995), 24 (2), pp. 68-75
[17] FARMAN, Allan G., FARMAN, Taeko T. Panoramic dental radiography using a chargecoupled device receptor.
    Journal of Digital Imaging, (1998), 11 (3 Suppl 1), pp. [d]166-168
[18] MASTORIS, M., LI, G., WELANDER, U., MCDAVID, W.D. Determination of the resolution of a digital
    system for panoramic radiography based on CCD technology. Oral Surgery, Oral Medicine, Oral Pathology,
    Oral Radiology, and Endodontics, (2004), 97(3), pp. 408-414
[19] WELANDER, U., LI, G., Mcdavid, W.D., TRONJE, G. Transtomography: A new tomographic scanning
    technique. Dentomaxillofacial Radiology, (2004), 33 (3), pp. 188-195
[20] OGAWA, K., LANGLAIS, R.P., MCDAVID, W.D., NOUJEIM, M., SEKI, K., OKANO, T., YAMAKAWA, T.,
    SUE, T. Development of a new dental panoramic radiographic system based on a tomosynthesis method.
    Dentomaxillofacial Radiology, (2010), 39 (1), pp. 47-53
[21] BROOKS, S.L., BRAND, J.W., GIBBS, S.J., HOLLENDER, L., LURIE, A.G., OMNELL, K.-.,
    WESTESSON, P.-L., WHITE, S.C. Imaging of the temporomandibular joint: A position paper of the American
    Academy of Oral and Maxillofacial Radiology. Oral Surgery, Oral Medicine, Oral Pathology, Oral Radiology,
    and Endodontics, (1997), 83 (5), pp. 609-618
[22] BRAND, J.W., EDWARDS, M., KATZ, J.O., GIBBS, S.J., LURIE, A.G., WHITE, S.C., Mcdavid, W.D.,
    ROSENSTEIN, M., KOVAL, T.M., SPAHN Jr., J.A., O'BRIEN, C.L. Radiation protection in dentistry. (2003),
    NCRP Report, (145), pp. i-164
[23] GIBBS, S.J., PUJOL, A., MCDAVID, W.D., WELANDER, U., TRONJE, G. Patient risk from rotational
    panoramic radiography. Dentomaxillofacial Radiology, (1988), 17 (1), pp. 25-32
[24] GIJBELS, F., JACOBS, R., BOGAERTS, R., DEBAVEYE, D., VERLINDEN, S., SANDERINK, G. Dosimetry
    of digital panoramic imaging. Part I: Patient exposure. Dentomaxillofacial Radiology, (2005), 34 (3), pp.
    145-149
[25] GIJBELS, F., JACOBS, R., DEBAVEYE, D., BOGAERTS, R., VERLINDEN, S., SANDERINK, G. Dosimetry
    of digital panoramic imaging. Part II: Occupational exposure. Dentomaxillofacial Radiology, (2005), 34 (3), pp.
    150-153
[26] GIJBELS, F., SANDERINK, G., WYATT, J., VAN DAM, J., NOWAK, B., JACOBS, R. Radiation doses of
    indirect and direct digital cephalometric radiography. British DentalJournal, (2004), 197 (3), pp. 149-152
[27] FARMAN, A.G. Evolution of CBCT: the tree now has two distinct branches. Ora Surgery, Oral Medicine, Oral
    Pathology, Oral Radiology and Endodontology, (2009), 107 (4), p. 449.
[28] SCARFE, W.C., FARMAN, A.G. What is Cone-Beam CT and How Does it Work・ Dental Clinics of North
    America, (2008), 52 (4), pp. 707-730
[29] LUDLOW, J.B., DAVIES-LUDLOW, L.E., BROOKS, S.L., HOWERTON, W.B. Dosimetry of 3 CBCT devices
    for oral and maxillofacial radiology: CB Mercuray, NewTom 3G and i-C. Dentomaxillofacial Radiology, (2006),
    35(4):219-26
[30] IPSM 64:1991,Data for estimating x-ray tube total filtration
[31] 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
[32] 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

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                                             T 60601-2-63 : 2019 (IEC 60601-2-63 : 2012,Amd.1 : 2017)
    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
[33] IEC 60601-2-32:1994,Medical electrical equipment−Part 2: Particular requirements for the safety of
    associated equipment of X-ray equipment
[34] JIS Z 4751-2-43:2012 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 60601-2-43:2010,Medical electrical equipment−Part 2-43: Particular
            requirements for the basic safety and essential performance of X-ray equipment for interventional
            procedures
[35] 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
[36] 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
[37] JIS T 60601-2-65 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
      注記 対応国際規格 : IEC 60601-2-65,Medical electrical equipment−Part 2-65: Particular requirements
            for the basic safety and essential performance of dental intra-oral X-ray equipment
[38] 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
[39] 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
[40] 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
[41] JIS Z 4905 写真−医用撮影用カセッテ・増感紙・フィルム−寸法及び仕様
[42] JIS Z 4910 診断用X線映像装置−汎用及び乳房用散乱線除去グリッドの特性
[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
      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

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                                   定義した用語の索引
    注記 この個別規格では,JIS Z 4005で“放射線(RADIATION)”を用いて定義した用語の幾つかを,
          副通則及び対応国際規格に合わせて“X線(X-RAY)”として定義している。このため,出典・
          定義した箇所にJIS Z 4005を引用している場合は,“放射線(RADIATION)”を“X線(X-RAY)
          に置き換えて読む必要がある。
    定義した用語(日本語)             定義した用語(英語)               出典・定義した箇所
1ピーク形X線高電圧装置      ONE-PEAK HIGH-VOLTAGE GENERATOR          201.3.210
移動形                      MOBILE                                   JIS T 0601-1:2017,3.65
意図する使用                INTENDED USE                             JIS T 0601-1: 2017,3.44
一次防護遮蔽体              PRIMARY PROTECTIVE SHIELDING             JIS T 0601-1-3:2015,3.47
医用電気機器(ME機器)      MEDICAL ELECTRICAL EQUIPMENT (ME         JIS T 0601-1:2017,3.63
                              EQUIPMENT)
医用電気システム(MEシステム)MEDICAL ELECTRICAL SYSTEM (ME SYSTEM)   IS T 0601-1:2017,3.64
インタロック                INTERLOCK                                201.3.207
永久設置形                  PERMANENTLY INSTALLED                    JIS T 0601-1:2017,3.84
X線(放射線)               X-RADIATION (RADIATION)                  JIS T 0601-1-3:2015,3.53
X線管                       X-RAY TUBE                               JIS T 0601-1-3:2015,3.83
[X線]管装置               X-RAY TUBE ASSEMBLY                      JIS T 0601-1-3:2015,3.84
[X線]管電圧               X-RAY TUBE VOLTAGE                       JIS T 0601-1-3:2015,3.88
[X線]管電流               X-RAY TUBE CURRENT                       JIS T 0601-1-3:2015,3.85
X線[管負荷]条件           LOADING FACTOR                           JIS T 0601-1-3:2015,3.35
[X線管]負荷状態           LOADING STATE                            JIS T 0601-1-3:2015,3.36
X線源                       X-RAY SOURCE                             JIS T 0601-1-3:2015,3.61
X線源装置                   X-RAY SOURCE ASSEMBLY                    JIS T 0601-1-3:2015,3.62
[X線]高電圧装置           HIGH-VOLTAGE GENERATOR                   JIS Z 4005:2012,10472-1
[X線]撮影[法]           RADIOGRAPHY                              JIS T 0601-1-3:2015,3.64
X線受像器                   X-RAY IMAGE RECEPTOR                     JIS T 0601-1-3:2015,3.81
X線照射野                   X-RAY FIELD                              JIS T 0601-1-3:2015,3.58
X線装置                     X-RAY EQUIPMENT                          JIS T 0601-1-3:2015,3.78
[X線]透視[法]           RADIOSCOPY                               JIS T 0601-1-3:2015,3.69
X線発生装置                 X-RAY GENERATOR                          JIS T 0601-1-3:2015,3.79
X線ビーム                   X-RAY BEAM                               JIS T 0601-1-3:2015,3.55
X線ビーム軸                 X-RAY BEAM AXIS                          JIS Z 4005:2012,10896
過電流開放器                OVER-CURRENT RELEASE                     JIS T 0601-1: 2017,3.74
患者                        PATIENT                                  JIS T 0601-1: 2017,3.76
患者測定電流                PATIENT AUXILIARY CURRENT                JIS T 0601-1:2017,3.77
患者漏れ電流                PATIENT LEAKAGE CURRENT                  JIS T 0601-1:2017,3.80
関心領域(ROI)             REGION OF INTEREST                       JIS Z 4005:2012,10986
管電流時間積                CURRENT TIME PRODUCT                     JIS T 0601-1-3:2015,3.16
関連機器                    ASSOCIATED EQUIPMENT                     JIS Z 4005:2012,10082
機械的ハザード              MECHANICAL HAZARD                        JIS T 0601-1:2017,3.61
機械的保護装置              MECHANICAL PROTECTIVE DEVICE             JIS T 0601-1:2017,3.62
危険状態                    HAZARDOUS SITUATION                      JIS T 0601-1:2017,3.40
基準軸                      REFERENCE AXIS                           JIS Z 4005:2012,10972
基礎安全                    BASIC SAFETY                             JIS T 0601-1:2017,3.10
基本性能                    ESSENTIAL PERFORMANCE                    JIS T 0601-1:2017,3.27
空気カーマ                  AIR KERMA                                JIS T 0601-1-3:2015,3.4

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                                             T 60601-2-63 : 2019 (IEC 60601-2-63 : 2012,Amd.1 : 2017)
    定義した用語(日本語)             定義した用語(英語)               出典・定義した箇所
空気カーマ率                AIR KERMA RATE                           JIS T 0601-1-3:2015,3.5
形式名称                    MODEL OR TYPE REFERENCE                  JIS T 0601-1:2017,3.66
減弱                        ATTENUATION                              JIS T 0601-1-3:2015,3.7
減弱当量                    ATTENUATION EQUIVALENT                   JIS T 0601-1-3:2015,3.8
口外法[用]                EXTRA-ORAL                               201.3.206
公称(値)                  NOMINAL (value)                          JIS T 0601-1:2017,3.69
公称[最大]電力            NOMINAL ELECTRIC POWER                   JIS Z 4005:2012,10704
公称管電圧                  NOMINAL X-RAY TUBE VOLTAGE               JIS T 0601-1-3:2015,3.42
公称最短照射時間            NOMINAL SHORTEST IRRADIATION TIME        201.3.209
公称焦点値                  NOMINAL FOCAL SPOT VALUE                 JIS Z 4005:2012,10709
高電圧                      HIGH VOLTAGE                             JIS T 0601-1:2017,3.41
高電圧発生装置              HIGH-VOLTAGE TRANSFORMER ASSEMBLY        JIS Z 4005:2012,10473
口内法[用]                INTRA-ORAL                               201.3.208
撮影用カセッテ              RADIOGRAPHIC CASSETTE                    JIS Z 4005:2012,10927
[散乱線除去]グリッド      ANTI-SCATTER GRID                        JIS Z 4005:2012,10057
散乱[放射]線              SCATTERED RADIATION                      JIS T 0601-1-3:2015,3.73
歯科[用]                  DENTAL                                   201.3.202
歯科用ボリューム再構成[X線 DENTAL VOLUMETRIC RECONSTRUCTION         201.3.203
撮影][法]                  (DVR)
指示値                      INDICATED VALUE                          JIS Z 4005:2012,10489
自動制御機能                AUTOMATIC CONTROL SYSTEM                 JIS T 0601-1-3:2015,3.9
自動線量率制御,自動輝度制御AUTOMATIC INTENSITY CONTROL              JIS Z 4005:2012,10100
自動露出制御                AUTOMATIC EXPOSURE CONTROL               JIS T 0601-1-3:2015,3.10
受像器面                    IMAGE RECEPTION PLANE                    JIS Z 4005:2012,10484
受像面                      IMAGE RECEPTION AREA                     JIS T 0601-1-3:2015,3.28
準備完了状態                READY STATE                              JIS Z 4005:2012,10964
照射                        IRRADIATION                              JIS T 0601-1-3:2015,3.30
照射イベント                IRRADIATION-EVENT                        IEC 61910-1:2014,3.1
照射時間                    IRRADIATION TIME                         JIS T 0601-1-3:2015,3.32
照射スイッチ                IRRADIATION SWITCH                       JIS T 0601-1-3:2015,3.31
照射野限定器                BEAM LIMITING DEVICE                     JIS T 0601-1-3:2015,3.11
照射野限定システム          BEAM LIMITING SYSTEM                     JIS T 0601-1-3:2015,3.12
焦点                        FOCAL SPOT                               JIS Z 4005:2012,10411
焦点外X線                   EXTRA-FOCAL RADIATION                    JIS T 0601-1-3:2015,3.22
焦点受像器間距離            FOCAL SPOT TO IMAGE RECEPTOR DISTANCE    JIS T 0601-1-3:2015,3.25
焦点皮膚間距離              FOCAL SPOT TO SKIN DISTANCE              JIS T 0601-1-3:2015,3.26
剰余放射線                  RESIDUAL RADIATION                       JIS T 0601-1-3:2015,3.72
制御盤                      CONTROL PANEL                            JIS T 0601-1-3:2015,3.14
正常状態                    NORMAL CONDITION                         JIS T 0601-1: 2017,3.70
正常な使用                  NORMAL USE                               JIS T 0601-1: 2017,3.71
製造業者                    MANUFACTURER                             JIS T 0601-1: 2017,3.55
責任部門                    RESPONSIBLE ORGANIZATION                 JIS T 0601-1:2017,3.101
接触電流                    TOUCH CURRENT                            JIS T 0601-1: 2017,3.129
接地漏れ電流                EARTH LEAKAGE CURRENT                    JIS T 0601-1: 2017,3.25
増感紙                      INTENSIFYING SCREEN                      JIS Z 4005:2012,10520
操作者                      OPERATOR                                 JIS T 0601-1: 2017,3.73
操作モード                  MODE OF OPERATION                        JIS T 0601-1-3:2015,3.40
測定値                      MEASURED VALUE                           JIS T 0601-1-3:2015,3.38
ターゲット角                TARGET ANGLE                             JIS Z 4005:2012,11145
単一故障状態                SINGLE FAULT CONDITION                   JIS T 0601-1: 2017,3.116
定格(値)                  RATED (value)                            JIS T 0601-1: 2017,3.97

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