EO Sterilization

老化試驗簡介

醫療器材無菌屏障系統加速老化試驗依參考規範做爆破測試、緩破測試、染料穿透試驗、封口強度試驗、無菌試驗,並依器械分類做環氧乙烷滅菌殘留檢測。參考規範ASTM、USP、ISO。
Accelerated Aging of Sterile Barrier Systems for Medical Device

醫療器材無菌屏障系統加速老化試驗

(參考規範 ASTM F1980 Accelerated Aging of Sterile Barrier Systems for Medical Device)

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)

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)

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)

封口強度試驗 Seal Peel Test

(參考規範ASTM F88 Seal Strength of Flexible Barrier Materials)

無菌試驗 Sterile Test

(參考規範USP 30 <71> Sterile Test)
Ethylene Oxide Sterilization Residue Detection

環氧乙烷滅菌殘留檢測

依器械分類做滅菌殘留檢測 (EO, ECH, EG)

(參考規範 ISO10993-7 Biological evaluation of medical devices —Part 7:Ethylene oxide sterilization residuals)