JIS T 0841-1:2019 最終段階で滅菌される医療機器の包装―第１部：材料，無菌バリアシステム及び包装システムに関する要求事項 | ページ 8

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T 0841-1 : 2019 (ISO 11607-1 : 2006,Amd.1 : 2014)
        リデーション
      注記 対応国際規格 : ISO 11607-2:2006,Packaging for terminally sterilized medical devices−Part 2:
            Validation requirements for forming, sealing and assembly processes
              なお,ISO 11607-2:2006には,Amendment 1:2014が発行されている。
[11] JIS T 0993-1 医療機器の生物学的評価−第1部 : リスクマネジメントプロセスにおける評価及び試験
      注記 対応国際規格 : ISO 10993-1:2009,Biological evaluation of medical devices−Part 1: Evaluation and
            testing within a risk management process
[12] JIS T 7322 医療用高圧蒸気滅菌器
[13] JIS T 7323 医療用酸化エチレンガス滅菌器
[14] JIS T 7324 医療用小型高圧蒸気滅菌器
[15] JIS T 7325 医療用小型酸化エチレンガス滅菌器
[16] JIS Z 9015-1 計数値検査に対する抜取検査手順−第1部 : ロットごとの検査に対するAQL指標型
        抜取検査方式
      注記 対応国際規格 : ISO 2859-1:1999,Sampling procedures for inspection by attributes−Part 1:
            Sampling schemes indexed by acceptance quality limit (AQL)   or lot-by-lot inspection
              なお,ISO 2859-1:1999には,Amendment 1:2011が発行されている。
[17] ISO 5636-2:1984,Paper and board−Determination of air permeance (medium range)−Part 2: Schopper
        method
[18] ISO/TS 11139:2006,Sterilization of health care products−Vocabulary
[19] ISO 14937:2000,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
[20] EN 285:1996+Amd.2:2009,Steam sterilizers−Large sterilizers
[21] EN 868-2:1999,Packaging materials and systems for medical devices which are to be sterilized−Part 2:
        Sterilization wrap−Requirements and test methods
[22] EN 868-3:2009,Packaging for terminally sterilized medical devices−Part 3: Paper for use in the manufacture
        of paper bags (specified in EN 868-4)   nd in the manufacture of pouches and reels (specified in EN 868-5)
        −Requirements and test methods
[23] EN 868-4:1999,Packaging materials and systems for medical devices which are to be sterilized−Part 4:
        Paper bags−Requirements and test methods
[24] EN 868-5:2009,Packaging for terminally sterilized medical devices−Part 5: Sealable pouches and reels of
        porous materials and plastic film construction−Requirements and test methods
[25] EN 868-6:2009,packaging for terminally sterilized medical devices−Part 6: Paper for low temperature
        sterilization processes−Requirements and test methods
[26] EN 868-7:2009,Packaging for terminally sterilized medical devices−Part 7: Adhesive coated paper for low
        temperature sterilization processes−Requirements and test methods
[27] EN 868-8:1999,Packaging materials and systems for medical devices which are to be sterilized−Part 8:
        Re-usable sterilization containers for steam sterilizers conforming to EN 285−Requirements and test
        methods
[28] EN 868-9:2000,Packaging materials and systems for medical devices which are to be sterilized−Part 9:

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                                                   T 0841-1 : 2019 (ISO 11607-1 : 2006,Amd.1 : 2014)
        Uncoated nonwoven materials of polyolefines for use in the manufacture of heat sealable pouches, reels
        and lids−Requirements and test methods
[29] EN 868-10:2000,Packaging materials and systems for medical devices which are to be sterilized−Part 10:
        Adhesive coated nonwoven materials of polyolefines for use in the manufacture of heat sealable pouches,
        reels and lids−Requirements and test methods
[30] EN 1422:1997,Sterilizers for medical purposes−Ethylene oxide sterilizers−Requirements and test methods
[31] EN 13795-1:2002+Amd.1:2009,Surgical drapes, gowns and clean air suits, used as medical devices for
        patients, clinical staff and equipment−Part 1: General requirements for manufacturers, processors and
        products
[32] EN 14180:2003+Amd.2:2009,Sterilizers for medical purposes−Low temperature steam and formaldehyde
        sterilizers−Requirements and testing
[33] ANSI/AAMI ST65:2008,Processing of reusable surgical textiles for use in health care facilities
[34] HANSEN, J., JONES, L., ANDERSON, H., LARSEN, C., SCHOLLA, M., SPITZLEY, J., and BALDWIN, A.
      1995. In quest of sterile packaging: Part 1: Approaches to package testing. Med. Dev. & Diag. Ind. 17 (8): pp.
      56-61
[35] JONES, L., HANSEN, J., ANDERSON, H., LARSEN, C., SCHOLLA, M., SPITZLEY, J., and BALDWIN, A.
      1995. In quest of sterile packaging: Part 2: Approaches to package testing. Med. Dev. & Diag. Ind. 17 (9): pp.
      72-79
[36] SCHOLLA, M., HACKETT, S., RUDYS, S., MICHELS, C. and BLETSOS, J. 2000. A potential method for
      the specification of microbial barrier properties. Med. Dev. Technol. 11 (3): pp. 12-16
[37] SCHOLLA, M., SINCLAIR, C.S., and TALLENTIRE, A. (1995). A European Consortium Effort to Develop a
      Physical Test for Assessing the Microbial Barrier Properties of Porous Medical Packaging Materials. In:
      Pharm. Med. Packaging 95, Copenhagen, Denmark
[38] TALLENTIRE, A. and SINCLAIR, C.S. (1996). A Discriminating Method for Measuring the Microbial
      Barrier Performance of Medical Packaging Papers. Med. Dev. Diag. Ind., 18 (5), pp. 228-241
[39] SINCLAIR, C.S. and TALLENTIRE, A. (2002)   efinition of a correlation between microbiological and
      physical articulate barrier performances for porous medical packaging materials. PDA J. Pharm. Sci. Technol.
      56 (1): pp. 11-9
[40] JUNGHANN, U., WINTERFELD, S., GABELE, L. and KULOW: U. Hygienic-Microbiological and
      Technical Testing of Sterilizer Container Systems, Zentr. Steril. 1999: 7 (3)   p. 154-162 under Sterile barrier
      systems, Package Integrity
[41] GABELE, L. and JUNGHANN, U. Untersuchung zur Lagerdauer von Sterilgut unter Einbezug des
      Sterilcontainers: Aseptica 6, 2000, pp. 5-7
[42] Merkblatt 45, Verpackungs-Rundschau 5/1982: Prfung von Heisiegelnhten auf Dichtigkeit, Herausgegeben
      von den Arbeitsgruppen der Industrievereinigung fr Lebensmitteltechnologie und Verpackung e. V. am
      Fraunhofer-Institut fr Lebensmitteltechnologie und Verpackung, Institut an der Technischen Universitt
      Mnchen
[43] DUNKELBERG, H. and WEDEKIND, S. A New Method for Testing the Effectiveness of the Microbial
      Barrier Properties of Packaging Materials for Sterile Products: Biomed. Technik, 47 (2002), pp. 290-293
[44] Test method for the microbial barrier properties of wrapping materials, new approach: Report No. 319 011.

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T 0841-1 : 2019 (ISO 11607-1 : 2006,Amd.1 : 2014)
      007 RIVM (Rijksinstituut voor volksgezondheid en milieuhygiene), Netherlands
[45] Test method for the microbial barrier properties of packaging for medical devices: Report No. 31900, RIVM
      (Rijksinstituut voor volksgezondheid en milieuhygiene), Netherlands
[46] International Vocabulary of Basic and General Terms in Metrology: 1993, BIPM, IEC, IFCC, ISO, IUPAC,
      IUPAP, OIML
[47] AORN Journal 26 (21:334-350)   icrobiology of Sterilization. Litsky, Bertha, Y. 1977
[48] USP 27<1031> The biocompatibility of materials used in drug containers, medical devices and implants
[49] Berry,C.W. and Harding,L.(2012),Validation of Test Methods for Characterizing and Specifying Materials
      Used in the Construction of Sterilization Packaging. Packag. Technol.Sci.
[50] D. Zahn, ISEGA Forschungs- und Untersuchungsgesellschaft mbH. Interlaboratory Test-“Microbial barrier
      testing of packaging materials for medical devices which are to be sterilized” according to DIN 58953-6:2010.
      Available on line from the Sterile Barrier Association (SBA)
      http://www.sterilebarrier.org/media/43501/Final-validation-report-germproofness-plus-author.pdf