【正文】 — 1—Technical Standard For disinfection (2021年版 ) 中華人民共和國(guó)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(yàn)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(jī)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(yǔ) ............................................................................................................................ 1 消毒產(chǎn)品功效檢驗(yàn)的基本原則和要求 ........................................................................... 3 消毒產(chǎn)品檢驗(yàn)基本要求 ............................................................................................. 3 消毒產(chǎn)品理化檢驗(yàn)基本要求 ...................................................................................... 7 消毒產(chǎn)品毒理學(xué)實(shí)驗(yàn)基本原則 ................................................................................... 8 醫(yī)療衛(wèi)生機(jī)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(yàn)技術(shù)規(guī)范 消毒產(chǎn)品消毒效果檢驗(yàn)技術(shù)規(guī)范 ................................................................................ 15 消毒劑殺微生物試驗(yàn) ............................................................................................... 15 消毒劑模擬現(xiàn)場(chǎng)和現(xiàn)場(chǎng)消毒鑒定試驗(yàn) ...................................................................... 43 空氣消毒效果鑒定試驗(yàn) ........................................................................................... 53 水的消毒效果鑒定試驗(yàn) ........................................................................................... 56 滅菌與消毒器械消毒功效鑒定試驗(yàn) .......................................................................... 62 滅菌與消毒指示器材鑒定試驗(yàn) ................................................................................. 75 滅菌醫(yī)療用品包裝材料鑒定試驗(yàn) ............................................................................. 80 抗（抑）菌試驗(yàn) ...................................................................................................... 83 一次性使用醫(yī)療用品產(chǎn)品細(xì)菌和真菌污染的檢測(cè) ..................................................... 94 隱形眼鏡護(hù)理液鑒定試驗(yàn) ...................................................................................... 99 一次性使用衛(wèi)生用品鑒定試驗(yàn) ............................................................................. 102 消毒產(chǎn)品理化檢驗(yàn)技術(shù)規(guī)范 ..................................................................................... 109 消毒產(chǎn)品原料或單方制劑的測(cè)定法 ........................................................................ 109 復(fù)方消毒產(chǎn)品有效成分含量測(cè)定的指導(dǎo)原則 .......................................................... 123 消毒產(chǎn)品穩(wěn)定性測(cè)定 ............................................................................................. 124 — 8— 消毒劑對(duì)金屬腐蝕性的測(cè)定 .................................................................................. 124 消毒產(chǎn)品毒理學(xué)實(shí)驗(yàn)技術(shù)規(guī)范 ................................................................................. 126 急性經(jīng)口毒性試驗(yàn) ................................................................................................ 126 急性吸入毒性 試驗(yàn) ................................................................................................ 128 皮膚刺激試驗(yàn) ....................................................................................................... 129 急性眼刺激試驗(yàn) .................................................................................................... 131 陰道黏膜刺激試驗(yàn) ................................................................................................ 132 皮膚變態(tài)反應(yīng)試驗(yàn) ................................................................................................ 134 亞急性毒性試驗(yàn) .................................................................................................... 135 致突變?cè)囼?yàn) ........................................................................................................... 136 亞慢性毒性試驗(yàn) .................................................................................................... 146 致畸胎試驗(yàn) ......................................................................................................... 147 慢性毒性試驗(yàn) ...................................................................................................... 148 致癌試驗(yàn) ............................................................................................................. 149 毒理學(xué)試驗(yàn)結(jié)果的最終判定 ................................................................................. 150 第三部分 醫(yī)療衛(wèi)生機(jī)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 ............