消毒技术规范
Technical Standard For disinfection
(2002年版)
中华人民共和国卫生部 二○○二年十一月
消毒技术规范
Technical Standard For disinfection
(2002年版)
中华人民共和国卫生部 二○○二年十一月 第一部分
Part 1
总 则
General Principle
第二部分
Part 2
消毒产品检验技术规范
Technical Standard for testing disinfection Products
第三部分
Part 3
医疗卫生机构消毒技术规范
Technical standard for Disinfection of Medical
and Health Structures
第四部分
Part 4
疫源地消毒技术规范
Technical Standard for Disinfection of
epidemic focus
消毒技术规范目录
第一部分 总 则
1.1 引言 ........................................................................................................................................... 1 1.2 适用范围 .................................................................................................................................. 1 1.3 术语 ........................................................................................................................................... 1 1.4 消毒产品功效检验的基本原则和要求 ........................................................................... 3 1.4.1 消毒产品检验基本要求 ................................................................................................... 3 1.4.2 消毒产品理化检验基本要求 .......................................................................................... 7 1.4.3 消毒产品毒理学实验基本原则 ...................................................................................... 8 1.4.4 医疗卫生机构消毒、灭菌基本要求 ............................................................................. 9 1.4.5 疫源地消毒基本要求 ...................................................................................................... 12
第二部分 消毒产品检验技术规范
2.1 消毒产品消毒效果检验技术规范 .................................................................................. 15 2.1.1 消毒剂杀微生物试验 ...................................................................................................... 15 2.1.2 消毒剂模拟现场和现场消毒鉴定试验 ...................................................................... 43 2.1.3 空气消毒效果鉴定试验 ................................................................................................. 53
2.1.4 水的消毒效果鉴定试验 ................................................................................................. 56 2.1.5 灭菌与消毒器械消毒功效鉴定试验 ........................................................................... 62 2.1.6 灭菌与消毒指示器材鉴定试验 .................................................................................... 75 2.1.7 灭菌医疗用品包装材料鉴定试验 ............................................................................... 80 2.1.8 抗（抑）菌试验 ............................................................................................................... 83 2.1.9 一次性使用医疗用品产品细菌和真菌污染的检测 ............................................... 94 2.1.10 隐形眼镜护理液鉴定试验 ........................................................................................... 99 2.1.11 一次性使用卫生用品鉴定试验 ............................................................................... 102 2.2 消毒产品理化检验技术规范......................................................................................... 109 2.2.1 消毒产品原料或单方制剂的测定法 ........................................................................ 109 2.2.2 复方消毒产品有效成分含量测定的指导原则 ...................................................... 123 2.2.3 消毒产品稳定性测定 ................................................................................................... 124 2.2.4 消毒剂对金属腐蚀性的测定 ..................................................................................... 124 2.3 消毒产品毒理学实验技术规范 .................................................................................... 126 2.3.1 急性经口毒性试验 ........................................................................................................ 126 2.3.2 急性吸入毒性试验 ........................................................................................................ 128 2.3.3 皮肤刺激试验 ................................................................................................................. 129 2.3.4 急性眼刺激试验 ............................................................................................................ 131 2.3.5 阴道黏膜刺激试验 ........................................................................................................ 132
2.3.6 皮肤变态反应试验 ........................................................................................................ 134 2.3.7 亚急性毒性试验 ............................................................................................................ 135 2.3.8 致突变试验 ..................................................................................................................... 136 2.3.9 亚慢性毒性试验 ............................................................................................................ 146 2.3.10 致畸胎试验 ................................................................................................................... 147 2.3.11 慢性毒性试验 ............................................................................................................... 148 2.3.12 致癌试验 ........................................................................................................................ 149 2.3.13 毒理学试验结果的最终判定 ................................................................................... 150
第三部分
医疗卫生机构消毒技术规范
3.1 消毒与灭菌方法 ............................................................................................................... 152 3.2 手术器械和用品的灭菌 .................................................................................................. 168 3.3 输注器材的灭菌 ............................................................................................................... 169 3.4 一般诊疗用品的消毒 ...................................................................................................... 170 3.5 内镜的消毒灭菌 ............................................................................................................... 171 3.6 医务人员手的消毒 ........................................................................................................... 173 3.7 皮肤与黏膜的消毒 ........................................................................................................... 174 3.8 医院室内空气的消毒 ...................................................................................................... 175 3.9 餐具和卫生洁具的消毒 .................................................................................................. 176