【正文】 — 1—Technical Standard For disinfection (2021年版 ) 中華人民共和國衛(wèi)生部 二○○二年十一月 — 2— — 3— 第一部分 Part 1 總 則 General Principle — 4— 第二部分 Part 2 消毒產(chǎn)品檢驗技術(shù)規(guī)范 Technical Standard for testing disinfection Products — 5— 第三部分 Part 3 醫(yī)療衛(wèi)生機構(gòu)消毒技術(shù)規(guī)范 Technical standard for Disinfection of Medical and Health Structures — 6— 第四部分 Part 4 疫源地消毒技術(shù)規(guī)范 Technical Standard for Disinfection of epidemic focus — 7— 消毒技術(shù)規(guī)范目錄 第一部分 總 則 引 言 ........................................................................................................................... 1 適用范圍 ..................................................................................................................... 1 術(shù)語 ............................................................................................................................ 1 消毒產(chǎn)品功效檢驗的基本原則和要求 ........................................................................... 3 消毒產(chǎn)品檢驗基本要求 ............................................................................................. 3 消毒產(chǎn)品理化檢驗基本要求 ...................................................................................... 7 消毒產(chǎn)品毒理學(xué)實驗基本原則 ................................................................................... 8 醫(yī)療衛(wèi)生機構(gòu)消毒、 滅菌基本要求 ............................................................................ 9 疫源地消毒基本要求 ............................................................................................... 12 第二部分 消毒產(chǎn)品檢驗技術(shù)規(guī)范 消毒產(chǎn)品消毒效果檢驗技術(shù)規(guī)范 ................................................................................ 15 消毒劑殺微生物試驗 ............................................................................................... 15 消毒劑模擬現(xiàn)場和現(xiàn)場消毒鑒定試驗 ...................................................................... 43 空氣消毒效果鑒定試驗 ........................................................................................... 53 水的消毒效果鑒定試驗 ........................................................................................... 56 滅菌與消毒器械消毒功效鑒定試驗 .......................................................................... 62 滅菌與消毒指示器材鑒定試驗 ................................................................................. 75 滅菌醫(yī)療用品包裝材料鑒定試驗 ............................................................................. 80 抗（抑）菌試驗 ...................................................................................................... 83 一次性使用醫(yī)療用品產(chǎn)品細菌和真菌污染的檢測 ..................................................... 94 隱形眼鏡護理液鑒定試驗 ...................................................................................... 99 一次性使用衛(wèi)生用品鑒定試驗 ............................................................................. 102 消毒產(chǎn)品理化檢驗技術(shù)規(guī)范 ..................................................................................... 109 消毒產(chǎn)品原料或單方制劑的測定法 ........................................................................ 109 復(fù)方消毒產(chǎn)品有效成分含量測定的指導(dǎo)原則 .......................................................... 123 消毒產(chǎn)品穩(wěn)定性測定 ............................................................................................. 124 — 8— 消毒劑對金屬腐蝕性的測定 .................................................................................. 124 消毒產(chǎn)品毒理學(xué)實驗技術(shù)規(guī)范 ................................................................................. 126 急性經(jīng)口毒性試驗 ................................................................................................ 126 急性吸入毒性 試驗 ................................................................................................ 128 皮膚刺激試驗 ....................................................................................................... 129 急性眼刺激試驗 .................................................................................................... 131 陰道黏膜刺激試驗 ................................................................................................ 132 皮膚變態(tài)反應(yīng)試驗 ................................................................................................ 134 亞急性毒性試驗 .................................................................................................... 135 致突變試驗 ........................................................................................................... 136 亞慢性毒性試驗 .................................................................................................... 146 致畸胎試驗 ......................................................................................................... 147 慢性毒性試驗 ...................................................................................................... 148 致癌試驗 ............................................................................................................. 149 毒理學(xué)試驗結(jié)果的最終判定 ................................................................................. 150 第三部分 醫(yī)療衛(wèi)生機構(gòu)消毒技術(shù)規(guī)范 消毒與滅菌方法 ...................................................................................................... 152 手術(shù)器械和用品的滅菌 ............................................................................................ 168 輸注器材的滅菌 ...................................................................................................... 169 一般診療用品的消毒 ............