JIS T 0806-1:2015 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 | ページ 8

                                                                                             33
                                                   T 0806-1 : 2015 (ISO 11137-1 : 2006,Amd.1 : 2013)
    elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE)   gents
[16] EN 556-1:2001,Sterilization of Medical Devices−Requirements for medical devices to be designated
    “STERILE”−Part 1: Requirements for terminally sterilized medical devices
[17] AAMI TIR17:1997,Radiation sterilization−Material qualification
[18] ANSI/AAMI ST67:2003,Sterilization of Medical Devices−Requirements for Products Labeled “Sterile”
[19] ANSI/HGB N43.10-2001,Safe Design and Use of Panoramic, Wet Source Storage Gamma Irradiators
    (Category IV)   nd Dry Source Storage Gamma Irradiators (Category II), Health Physics Society, McLean, VA,
    2001
[20] IAEA Safety Series No. 107, Radiation Safety of Gamma and Electron Irradiation Facilities, Vienna, 1992
[21] Global Harmonization Task Force (GHTF)−Study Group 1 (SG1), Document N029R16:2005−Information
    Document concerning the definition of the term “Medical Device”
[22] GRGOIRE, O., CLELAND, M.R., MITTENDORFER, J., VANDER DONCKT, M. and MEISSNER, J.
    Radiological safety of medical devices sterilized with X-rays at 7.5 MeV, Radiation Physics and Chemistry 67,
    Issue 2, June 2003, pp. 149-16