WS-T 10009-2023 消毒产品检测方法

ICS 11.080 CCS C 59 WS 中华人民共和国卫生行业标准 WS/T 10009—2023 消毒产品检测方法 Test methods of disinfection products 2023-12-15发布 2024 -05-01实施国家疾病预防控制局发布 WS/T 10009 —2023 I 目次前言 ................................ ................................ .......... III 1 范围 ................................ ................................ ................ 1 2 规范性引用文件 ................................ ................................ ...... 1 3 术语和定义 ................................ ................................ .......... 2 4 基本要求 ................................ ................................ ............ 4 4.1 实验室要求 ................................ ................................ ...... 4 4.2 人员要求 ................................ ................................ ........ 5 4.3 消毒效果检测要求 ................................ ................................ 5 4.4 理化检测要求 ................................ ................................ .... 7 4.5 毒理学评价要求 ................................ ................................ .. 8 4.6 检测记录要求 ................................ ................................ ... 11 4.7 检测报告要求 ................................ ................................ ... 12 4.8 消毒效果评价要求 ................................ ............................... 12 5 消毒效果检测与评价方法 ................................ ............................. 12 5.1 消毒剂消毒与灭菌效果验证试验 ................................ ................... 12 5.2 消毒剂模拟现场和现场消毒与灭菌效果鉴定试验 ................................ ..... 44 5.3 空气消毒效果鉴定试验 ................................ ........................... 63 5.4 水消毒效果评价试验 ................................ ............................. 69 5.5 消毒器械（含灭菌器械）鉴定试验 ................................ ................. 73 5.6 消毒与灭菌指示物鉴定试验 ................................ ...................... 102 5.7 灭菌医疗用品包装材料鉴定试验 ................................ .................. 121 5.8 抗（抑）菌产品鉴定试验 ................................ ....................... 127 6 理化检测技术 ................................ ................................ ...... 127 6.1 消毒产品原料或单方制剂的测定方法 ................................ .............. 127 6.2 复方消毒剂有效成分含量测定的指导原则 ................................ .......... 186 6.3 pH值的测定 ................................ ................................ .... 186 6.4 氧化还原电位（ ORP）的测定 ................................ ..................... 187 6.5 铅的测定 ................................ ................................ ...... 187 6.6 砷的测定 ................................ ................................ ...... 188 6.7 汞的测定 ................................ ................................ ...... 190 6.8 消毒剂稳定性测定 ................................ .............................. 190 6.9 消毒剂对金属腐蚀性的测定 ................................ ...................... 193 7 毒理学试验方法 ................................ ................................ .... 197 7.1 急性经口毒性试验 ................................ .............................. 197 7.2 急性吸入毒性试验 ................................ .............................. 205 7.3 皮肤刺激试验 ................................ ................................ .. 206 7.4 急性眼刺激试验 ................................ ................................ 208 7.5 阴道黏膜刺激试验 ................................ .............................. 210 7.6 皮肤变态反应试验 ................................ .............................. 212 7.7 亚急性经口毒性试验 ................................ ............................ 214 WS/T 10009 —2023 II 7.8 致突变试验 ................................ ................................ .... 215 7.9 亚慢性毒性试验 ................................ ................................ 227 7.10 致畸试验 ................................ ................................ ..... 228 7.11 慢性毒性试验 ................................ ................................ . 230 7.12 致癌试验 ................................ ........................