JIS T 11737-2:2013 医療機器の滅菌―微生物学的方法―第２部：滅菌プロセスの定義，バリデーション及び維持において実施する無菌性の試験 | ページ 4

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T 11737-2 : 2013 (ISO 11737-2 : 2009)
                                          参考文献
[1] JIS T 0801-1 ヘルスケア製品の滅菌−エチレンオキサイド−第1部 : 医療機器の滅菌プロセスの開発,
    バリデーション及び日常管理の要求事項
      注記 対応国際規格 : ISO 11135-1,Sterilization of health care products−Ethylene oxide−Part 1:
            Requirements for development, validation and routine control of a sterilization process for medical
            devices(IDT)
[2] ISO/TS 11135-2, Sterilization of health care products−Ethylene oxide−Part 2: Guidance on the application of
    ISO 11135-1
[3] JIS T 0806-1 ヘルスケア製品の滅菌−放射線−第1部 : 医療機器の滅菌プロセスの開発,バリデーシ
    ョン及び日常管理の要求事項
      注記 対応国際規格 : ISO 11137-1,Sterilization of health care products−Radiation−Part 1: Requirements
            for development, validation and routine control of a sterilization process for medical devices(IDT)
[4] JIS T 0806-2 ヘルスケア製品の滅菌−放射線−第2部 : 滅菌線量の確立
      注記 対応国際規格 : ISO 11137-2,Sterilization of health care products−Radiation−Part 2: Establishing
            the sterilization dose(IDT)
[5] ISO 11138-2, Sterilization of health care products−Biological indicators−Part 2: Biological indicators for
    ethylene oxide sterilization processes
[6] ISO/TS 11139:2006, Sterilization of health care products−Vocabulary
[7] ISO 14160:1998, Sterilization of single-use medical devices incorporating materials of animal origin−
    Validation and routine control of sterilization by liquid chemical sterilants
[8] ISO 14161, Sterilization of health care products−Biological indicators−Guidance for the selection, use and
    interpretation of results
[9] JIS B 9920 クリーンルームの空気清浄度の評価方法
      注記 対応国際規格 : ISO 14644-1,Cleanrooms and associated controlled environments−Part 1:
            Classification of air cleanliness(MOD)
[10] JIS B 9919 クリーンルームの設計・施工及びスタートアップ
      注記 対応国際規格 : ISO 14644-4,Cleanrooms and associated controlled environments−Part 4: Design,
            construction and start-up(MOD)
[11] JIS B 9917-7 クリーンルーム及び関連制御環境−第7部 : 隔離装置
      注記 対応国際規格 : ISO 14644-7,Cleanrooms and associated controlled environments−Part 7:
            Separative devices (clean air hoods, gloveboxes, isolators and mini-environments)(IDT)
[12] ISO 14937, Sterilization of health care products−General requirements for characterization of a sterilizing
    agent and the development, validation and routine control of a sterilization process for medical devices
[13] JIS T 0816-1 ヘルスケア製品の滅菌−湿熱−第1部 : 医療機器の滅菌プロセスの開発,バリデーショ
    ン及び日常管理の要求事項
      注記 対応国際規格 : ISO 17665-1,Sterilization of health care products−Moist heat−Part 1:
            Requirements for the development, validation and routine control of a sterilization process for
            medical devices(IDT)

――――― [JIS T 11737-2 pdf 16] ―――――

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                                                               T 11737-2 : 2013 (ISO 11737-2 : 2009)
[14] ISO 20857, Sterilization of health care products−Dry heat−Requirements for the development, validation and
    routine control of a sterilization process for medical devices
[15] JIS Q 9000:2006 品質マネジメントシステム−基本及び用語
      注記 対応国際規格 : ISO 9000:2005,Quality management systems−Fundamentals and vocabulary(IDT)
[16] JIS Q 9001:2008 品質マネジメントシステム−要求事項
      注記 対応国際規格 : ISO 9001:2008,Quality management systems−Requirements(IDT)
[17] ISO/IEC 90003, Software engineering−Guidelines for the application of ISO 9001:2000 to computer software
[18] AKERS, J.D., et al., Survey on Sterility Testing Practices, J. Parenteral Sci. Technol., 41, 6, 1987
[19] ALEXANDER, K. and BRYANS, T., Evaluation of the Sterility Test for Detection of Microbial Contaminants
    of Allografts, Cell and Tissue Banking, 7, 1, pp. 2328, 2006
[20] Association of Analytical Chemists. Official Methods of Analysis. 15th ed., Arlington, AOAC; pp. 430437,
    1992
[21] Association of Analytical Chemists. Bacteriological Analytical Manual (BAM). 6th ed., Arlington, AOAC;1984
[22] BLOCK, S.S., Disinfection, Sterilization and Preservation, 5th ed., 2001
[23] GERHARDT, P., et al., Manual of Methods for General Bacteriology, American Society for Microbiology,
    Washington, DC, 1981
[24] MATHEWS, A.G., Optimal incubation conditions for sterility tests, Develop. Biol. Stand., 23, pp. 94102, 1974
[25] MELTZER, L.L. and ORDAL, Z.J., Thermal Injury and Recovery of Bacillus subtilus, Applied Microbiology,
    24, 6, pp. 878884, 1972
[26] RUSSELL, A.D., Principles of Antimicrobial Activity, in Block, S.S., (ed.)   isinfection, Sterilization and
    Preservation, Lea & Febiger, Philadelphia, PA, 4th edition, p. 27, 1991
[27] SOKOLSKI, W.T. and CHIDESTEY, C.G., Improved viable counting method for petroleumbased ointments, J.
    Pharm. Sci., 53, pp. 103107, 1964
[28] STRAKA, R.P. and STOKES, J.L., Rapid destruction of bacteria in commonly used diluents and its elimination.
    J. App. Microbiology, 5, p. 21, 1957
[29] The European Pharmacopoeia, 6th ed., European Directorate for the Quality of Medicines (EDQM), Strasbourg,
    2008
[30] 日本薬局方
[31] The United States Pharmacopoeia, 31st ed., United States Pharmacopoeial Convention (USP), Rockville, MD