EO Sterilization 老化試驗簡介

  • 醫療器材無菌屏障系統加速老化試驗
    Accelerated Aging of Sterile Barrier Systems for Medical Device
    (參考規範ASTM F1980 Accelerated Aging of Sterile Barrier Systems for Medical Device)-
    (a) 爆破測試 Burst Test for Packaging
    (參考規範ASTM F1140 Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages)
    (b) 緩破測試Creep Test for Packaging
    (參考規範ASTM F1140 Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages)
    (c) 染料穿透試驗Dye Penetration test
    (參考規範ASTM F1929 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration)
    (d) 封口強度試驗 Seal Peel Test(參考規範ASTM F88 Seal Strength of Flexible Barrier Materials)
    (e) 無菌試驗 Sterile Test (參考規範USP 30<71> Sterile Test)
  • 環氧乙烷滅菌殘留檢測
    (參考規範 ISO10993-7 Biological evaluation of medical devices —Part 7:Ethylene oxide sterilization residuals)-依器械分類做滅菌殘留檢測 (EO, ECH, EG)