如何选择正确的低温灭菌方式.ppt

External Release Copyright ? 2012, 3M. All rights reserved ? 3M 2011. All Rights Reserved. 环氧乙烷与过氧化氢等离子成本比较 External Release Copyright ? 2012, 3M. All rights reserved 压力蒸汽灭菌器与低温蒸汽甲醛灭菌器的复合体 低温蒸汽甲醛 气态甲醛(CH2O) (2 - 5 %) + 低温蒸汽 (50 – 80 oC) External Release Copyright ? 2012, 3M. All rights reserved 甲醛/压力蒸汽一体化 通风时间缩短 优势： 低温蒸汽甲醛 External Release Copyright ? 2012, 3M. All rights reserved Limitations:缺陷： 有限的穿透能力：高于过氧化氢等离子，低于ETO 灭菌温度：75-80度 严重的毒性 过程控制的问题：被蒸汽冷凝水吸附，降低浓度 干燥时，被水吸附的福尔马林聚合－多聚甲醛残留 无法提供灭菌监测 在北美不使用。在欧洲非常有限，且呈下降趋势 低温蒸汽甲醛 福尔马林熏箱不能用于灭菌 低温灭菌法律法规回顾 美国2006年供应室验收标准EO必须配置。 低温生物监测只有EO、辐照经过FDA认证。 植如物只有高温、EO、辐照经过FDA认证。 2005年发布环氧乙烷灭菌器标准 2009年卫生部规范EO 作为低温首选。 External Release Copyright ? 2012, 3M. All rights reserved 压力蒸汽仍然是首选的灭菌方法 所有的低温灭菌技术都有优势和劣势 选择一个正确的低温灭菌方法和过程以符合你平时的工作 应兼顾现在和将来的需求选择低温灭菌技术 使用的灭菌设备必须具备卫生部消毒许可批件 结 论 * * * Both of these documents provide guidance for a total approach to the respective sterilization process Currently no such document for h202 plasma processes * * Both of these documents provide guidance for a total approach to the respective sterilization process Currently no such document for h202 plasma processes * * 13 12 * * * * This document is used primarily by medical device manufacturers Primary recommended practice document for ethylene oxide sterilization There is no equivalent document for hydrogen peroxide gas plasma sterilization * * * * * * * * 19 * Both of these documents provide guidance for a total approach to the repective sterilization process Currently no such document for h202 plasma processes * The steam sterilization process is tested daily to every load with a biological indicator. Every load that contains an implantable medical device has a biological indicator and the departments try to quarantine the implantable medical device until the biological indicator is negative. * * * * 0.01 to 1.2 ppm may irritate the eyes 0.05 ppm can normally be smelled 0.05 ppm is regarded in some countries as