開課講師｜張志豪
課程資訊｜2025.6.14-7
報名方式｜線上報名
課程介紹｜
ISO11137 是醫療保健產品輻射滅菌的國際標準， 根據 ISO11137-2，輻射滅菌確效至少包括:Method 1、Method 2、Method VD max …等方法，本簡報內容皆引用自 ISO11137-2:2013 的內容，除介紹輻射滅菌確效之原理，並簡介 Method 1、Method VDmax 25、Method VDmax 15之確效程序，期能提供組織庫在滅菌確效程序上之參考。目前已滅菌的組織如:骨頭、軟骨、韌帶、肌腱、筋膜、硬腦膜、心臟瓣膜、血管、皮膚和羊膜，在規劃滅菌確效時至少須注意: 組織中生物負荷類型和水平的差異是否較大?、樣品物理特性（形狀和密度）的均勻性、樣品中生物負載的均勻性、供體病毒污染篩檢…等，以確保其臨床安全使用。
ISO11137 is the international standard for radiation sterilization of health care products. According to ISO11137-2, radiation sterilization validation includes at least: Method 1, Method 2, Method VDmax, etc. The contents of this briefing are all quoted from ISO11137-2:2013. In addition to introducing the principles of radiation sterilization validation, it also briefly introduces the validation procedures of Method 1, Method VDmax 25, and Method VDmax 15, hoping to provide a reference for tissue banks in the sterilization validation procedures. Currently, sterilized tissues such as bones, cartilage, ligaments, tendons, fascia, dura mater, heart valves, blood vessels, skin, and amniotic membranes must be considered when planning sterilization validation: Is there a large difference in the type and level of bioburden in the tissue? The uniformity of the physical properties (shape and density) of the sample, the uniformity of the bioburden in the sample, and the screening of donor virus contamination, etc., to ensure their safe clinical use.

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