EO Sterilization 生菌試驗(Bioburden)簡介

  • 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。
  • 為何要做 Bioburden Test?
    依據各式醫材之Bioburden,來決定滅菌參數。
  • 什麼時候要做 Bioburden Test?
    本實驗室依據ISO11135規範,來驗證環氧己烷滅菌確效製程,以確保其安全性及有效性。
生菌試驗(Bioburden Test)實驗室
  • 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。
  • 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。