JIS Z 4751-2-43:2021 医用電気機器―第２－４３部：ＩＶＲ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 10

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   等カーマ分布図は,単位Gy/Gy  cm2(1 Gy  cm2当たりの空気カーマ)で与えられる。
                        図BB.2−垂直方向 高さ100 cmの等カーマ分布図例

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                                         附属書CC
                                          (参考)
       旧規格(2012年版)とそれ以前の規格(2005年版)との対応表
  (対応国際規格では,この附属書において,この個別規格の2005年版と2012年版との対比表を記載し
ているが,不要であり,不採用とした。)

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                                 Z 4751-2-43 : 2021 (IEC 60601-2-43 : 2010,Amd.1 : 2017,Amd.2 : 2019)
                                          参考文献
    注記1 IEC規格は,https://www.iec.ch/から入手可能である。
    注記2 ISO規格は,https://www.iso.org/home.htmlから入手可能である。
[1] IEC/TR 62348:2006,Mapping between the clauses of the third edition of IEC 60601-1 and the 1988 edition as
    amended
[2] 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 原国際規格では,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を記載
            している。
]3[ 21 CFR Part 1020 Electronic Products: Performance Standard for Diagnostic X-Ray Systems and Their Major
    Components: Final Rule. Federal Register / Vol. 70, No. 111 / Friday, June 10, 2005 / Rules and Regulations.
[4] US Food and Drug Administration−Avoidance of serious X-ray induced skin injuries to patients during
    fluoroscopically-guided procedures. Warning issued on September 30, 1994.
[5] US Food and Drug Administration−Recording information in the patient's medical record that identifies the
    potential for serious X-ray induced skin injuries. Advice issued on September 15, 1995.
[6] Shope T.B.−Radiation-induced skin injuries from fluoroscopy. Radiographics 1996,16:1195−1199.
[7] Vano E., Arranz L., Sastre J.M., Moro C., Ledo A., Garate T.M., Minguez I.−Dosimetric and radiation
    protection considerations based on some cases of patient skin injuries in interventional cardiology Br. J. Radiol.
    1998, 71:510−516
[8] Hymes S.R., Strom E.A., Fife C.−Radiation dermatitis: clinical presentation, pathophysiology, and treatment J.
    Am. Acad. Dermatol. 2006, 54:28-46.
[9] Koenig T.R., Wolff D., Mettler F.A., Wagner L.K.−Skin injuries from fluoroscopically guided procedures: Part
    1, characteristics of radiation injury AJR 2001, 177:3-11.
[10] Miller D.L., Balter S., Cole P.E., et al.−Radiation doses in interventional radiology procedures: the RAD-IR
     study. Part II: skin dose J. Vasc. Interv. Radiol. 2003, 14:977-990.
[11] ODea T.J., Geise R.A., Ritenour E.R.−The potential for radiation-induced skin damage in interventional
     neuroradiological procedures: A review of 522 cases using automated dosimetry Med. Phys. 1999,
     26:2027-2033.
[12] Rosenthal L.S., Mahesh M., Beck T.J., et al.−Predictors of fluoroscopy time and estimated radiation exposure
     during radiofrequency catheter ablation procedures Am. J. Cardiol. 1998, 82:451-458.
[13] Suzuki S., Furui S., Kohtake H., et al.−Radiation exposure to patients skin during percutaneous coronary
     intervention for various lesions, including chronic total occlusion Circ. J. 2006, 70:44-48.
[14] Miller D.L., Balter S., Wagner L.K., et al.−Quality improvement guidelines for recording patient radiation
     dose in the medical record J. Vasc. Interv. Radiol. 2004, 15:423-429.
[15] Van de Putte S., Verhaegen F., Taeymans Y., Thierens H.−Correlation of patient skin doses in cardiac
     interventional radiology with dose-area product Br. J. Radiol. 2000, 73:504-513.

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Z 4751-2-43 : 2021 (IEC 60601-2-43 : 2010,Amd.1 : 2017,Amd.2 : 2019)
[16] Vano E., Goicolea J., Galvan C., et al.−Skin radiation injuries in patients following repeated coronary
     angioplasty procedures Br. J. Radiol. 2001, 74:1023-1031.
[17] Vano E., Gonzalez L., Ten J.I., Fernandez J.M., Guibelalde E., Macaya C.−Skin dose and dose-area product
     values for interventional cardiology procedures Br. J. Radiol. 2001, 74:48-55.
[18] Amis E.S., Butler P.F., Applegate K.E., et al.−American College of Radiology white paper on radiation dose
     in medicine J. Am. Coll. Radiol. 2007, 4:272-284.
[19] Lichtenstein D.A., Klapholz L., Vardy D.A., et al.−Chromic radiodermatitis following cardiac catheterization
     Arch. Dermatol. 1996, 132:663-667.
[20] NEMA Standards Publication XR-24 Primary User Controls for Interventional Angiography X-Ray Equipment
     2008.
[21] Gfirtner H., Stieve F.-E., Wild J.−A new Diamentor for measuring kerma-area product and air-kerma
     simultaneously Med. Phys. 1997, 24:1954-1959.
[22] International Commission on Radiation Units and Measurements−Avoidance of radiation injuries from
     medical interventional procedures. ICRP Publication 85. Ann. ICRP 2001, 30(2)
[23] National Council on Radiation Protection and Measurements. Radiation Dose Management for
     Fluoroscopically-Guided Interventional Medical Procedures. NCRP Report 168, Bethesda, MD, 2010
[24] International Commission on Radiological Protection. Radiological Protection in Cardiology, ICRP Publication
     120, Ann. ICRP 42(1), 2013: 1-125
[25] Miller, D.L., Balter S., Dixon R.G., Nikolic B., Bartal G., Cardella J.F., Dauer L.T., Stecker M.S. Quality
     improvement guidelines for recording patient radiation dose in the medical record for fluoroscopically guided
     procedures. J Vasc Interv Radiol, 2012, 23(1):11-18
[26] Chambers, C.E., Fetterly K.A., Holzer R., Lin P.J., Blankenship J.C., Balter S., Laskey W.K. Radiation safety
     program for the cardiac catheterization laboratory. Catheter Cardiovasc Interv, 2011. 77(4):546-556
[27] Stecker M.S., Balter S., Towbin R.B., Miller D.L., Vano E., Bartal G., Angle J.F., Chao C.P., Cohen A.M.,
     Dixon R.G., Gross K., Hartnell G.G., Schueler B., Statler J.D., de Bare T., Cardella J.F. Guidelines for patient
     radiation dose management. J Vasc Interv Radiol. 2009:20(7S):S263-S273
[28] Duran A., Hian S.K., Miller D.L., Le Heron J., Padovani R., Vano E. Recommendations for occupational
     radiation protection in interventional cardiology. Catheter Cardiovasc Interv. 2013, 82:29-42
[29] Miller D.L., Balter S., Noonan P.T., Georgia J.D. Minimizing radiation-induced skin injury in interventional
     radiology procedures. Radiology, 2002, 225(2):329-336
[30] Kimpe T., Rostang J., Van Hoey G., Xthona A. Color standard display function: A proposed extension of
     DICOM GSDF. Med. Phys., 2016, 43:5009-5019
[31] 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 原国際規格では,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を記載し
            ている。
[32] IEC 60601-1-9,Medical electrical equipment−Part 1-9: General requirements for basic safety and essential

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     performance−Collateral Standard: Requirements for environmentally conscious design
[33] 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
[34] 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
[35] 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 intended for use in the emergency medical services environment

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