EO Sterilization
生菌試驗（Bioburden）簡介
生菌試驗(Bioburden Test)為檢測已完成包裝之未滅菌醫療器材產品，所存活之微生物總數，並依據各式醫療器材之Bioburden，來決定滅菌參數。
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何謂 Bioburden Test？
檢測已完成包裝之未滅菌醫療器材產品，所存活之微生物總數，顧名思義又稱為生菌試驗。item02
為何要做 Bioburden Test？
依據各式醫材之 Bioburden，來決定滅菌參數。item03
什麼時候要做 Bioburden Test？
本實驗室依據 ISO11135 規範，來驗證環氧乙烷滅菌確效製程，以確保其安全性及有效性。item04
Bioburden Test 標準方法
本實驗室以ISO 11737-1:2006 Sterilization of medical devices — Microbiological methods —- Part 1：Determination of a population of microorganisms on products、ISO 11737-2:2009 Sterilization of medical devices — Microbiological methods —
- Part 2：Tests of sterility performed in the definition, validation and maintenance of a sterilization process及USP-30 <71> Sterility Test，為醫療器材產品驗證方法準則。
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Bioburden Test 多少時間可以測得？
以ISO 11737-1:2006 Sterilization of medical devices — Microbiological methods —- Part 1：Determination of a population of microorganisms on products、ISO 11737-2:2009 Sterilization of medical devices — Microbiological methods —
- Part 2：Tests of sterility performed in the definition, validation and maintenance of a sterilization process及USP-30 <71> Sterility Test 規範，培養天數需為7天。