【正文】 生物指示劑（ BIs） ................................................................................................20 化學(xué)監(jiān)測器 .............................................................................................................21 熱力學(xué)和蒸汽質(zhì)量 ............................................................................................................22 溫度和熱量 .............................................................................................................22 蒸汽 .........................................................................................................................28 純蒸汽質(zhì)量的測試 .................................................................................................28 滅菌程序的開發(fā) ......................................................................................................................30 設(shè)計(jì)方法 ...........................................................................................................................30 滅菌程序設(shè)計(jì)方法中殘存曲線的應(yīng)用 .................................................................31 裝載類型 ...........................................................................................................................34 多孔 /堅(jiān)硬裝載的定義 ............................................................................................34 液體裝載的定義 .....................................................................................................34 滅菌程序 ...........................................................................................................................35 飽和蒸汽滅菌程序 .................................................................................................35 空氣加壓程序 .........................................................................................................38 滅菌程序的開發(fā) ...............................................................................................................40 多孔 /堅(jiān)硬裝載滅菌程序的開發(fā) ............................................................................40 液體裝載滅菌程序的建立 .....................................................................................45 穩(wěn)定性研究 .......................................................................................................................48 滅菌程序的性能確認(rèn) ..............................................................................................................48 物理確認(rèn) ...........................................................................................................................49 熱分布 .....................................................................................................................49 熱穿透 .....................................................................................................................49 生物指示劑確認(rèn) ...............................................................................................................50 生物指示劑挑戰(zhàn)系統(tǒng) .............................................................................................50 生物指示劑的使用和放置 .....................................................................................51 滅菌程序性能確認(rèn)合格標(biāo)準(zhǔn) ...........................................................................................52 等效滅菌器 ........................................................................................................................53 分組法 ...............................................................................................................................54 典型產(chǎn)品法 .............................................................................................................54 典型容器規(guī)格 /裝量法 ............................................................................................54 典型物品法 .............................................................................................................54 典型裝載法 .............................................................................................................54 日常工藝控制 ...............................................................................