CNAS-CL60 实验动物饲养和使用机构质量和能力认可准则
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CNAS-CL60
实验动物饲养和使用机构质量和能力认可准则
Accreditation criteria for the quality and competence of laboratory animal institutions for care and using
2017 年6月1日 实施
2017 年6月1日发布 目 次 前言............................................................................................................................4 引言............................................................................................................................5 1 范围 ........................................................................................................................6 2 规范性引用文件 ......................................................................................................6 3 术语与定义 ..............................................................................................................6 4 管理体系 .................................................................................................................7 4.1 组织和管理.....................................................................................................7 4.2 人员要求 ......................................................................................................10 4.3 管理体系文件...............................................................................................10 4.4 管理手册 ......................................................................................................10 4.5 程序文件 ...................................................................................................... 11 4.6 说明及操作规程 ........................................................................................... 11 4.7 安全手册 ...................................................................................................... 11 4.8 记录 ............................................................................................................. 11 4.9 标识系统 ......................................................................................................12 4.10 文件控制 ....................................................................................................12 4.11 工作计划 ....................................................................................................13 4.12 检查 ...........................................................................................................13 4.13 不符合项的识别和控制...............................................................................14 4.14 纠正措施 ....................................................................................................14 4.15 预防措施 ....................................................................................................15 4.16 持续改进 ....................................................................................................15 4.17 内部审核 ....................................................................................................15 4.18 管理评审 ....................................................................................................15 4.19 应急管理和事故报告 ..................................................................................16 5 实验动物设施........................................................................................................17 5.1 规划与设计 ....................................................................................................17 5.2 建造要求........................................................................................................20 5.2.1 总则........................................................................................................20 5.2.2 走廊........................................................................................................20 5.2.3 围护结构.................................................................................................20 5.2.4 通风和空调 .............................................................................................21 5.2.5 给水和排水 .............................................................................................22 5.2.6 污物处理和消毒灭菌...............................................................................22 5.2.7 电力和照明 .............................................................................................23 5.2.8 通讯........................................................................................................23 5.2.9 自控、监视和报警 ...................................................................................23 5.2.10 存储区 ..................................................................................................24 5.2.11 洗刷和消毒 ...........................................................................................24 5.2.12 手术室 ..................................................................................................24 5.2.13 水生动物饲养室....................................................................................25 5.2.14 其它特殊用途的设施.............................................................................26 5.2.15 室内饲养笼具........................................................................................26 5.2.16 室外饲养房舍.........................................................................................26 6 动物饲养................................................................................................................26 6.1 总则................................................................................................................26 6.2 环境控制与监测 .............................................................................................27 6.3 动物行为管理..................................................................................................27 6.4 动物身份识别..................................................................................................28 6.5 动物遗传学特性监测和基因操作 .....................................................................28 6.6 动物营养与卫生 .............................................................................................29 6.7 饲养环境的卫生 .............................................................................................30 6.8 废物管理........................................................................................................30 6.9 假日期间动物的管理......................................................................................31 7 动物医护 ...............................................................................................................31 7.1 采购动物.........................................................................................................31 7.2 包装与运输动物..............................................................................................31 7.3 动物疾病预防与控制.......................................................................................32 7.3.1 总则........................................................................................................32 7.3.2 检疫与隔离 .............................................................................................33 7.3.3 疾病监视和监测......................................................................................33 7.3.4 疾病控制.................................................................................................34 7.3.5 动物的生物安全......................................................................................34 7.4 动物疾病治疗与护理......................................................................................34 7.4.1 总则........................................................................................................34 7.4.2 手术及护理 .............................................................................................35 7.4.2.1 手术计划..............................................................................................35 7.4.2.2 术前准备..............................................................................................35 7.4.2.3 麻醉与镇痛 ..........................................................................................36 7.4.2.4 手术.....................................................................................................36 7.4.2.5 术中监护..............................................................................................36 7.4.2.6 术后观察和护理...................................................................................37 7.4.3 疼痛与痛苦 .................................................................................................37 7.4.4 急救............................................................................................................37 7.4.5 安死术.........................................................................................................37 7.4.6 人道终止时机..............................................................................................38 7.4.7 病历............................................................................................................38 8 职业健康安全........................................................................................................38 8.1 总则................................................................................................................38 8.2 风险评估.........................................................................................................40 8.3 危险源管理与控制...........................................................................................40 8.4 员工行为规范.................................................................................................41 8.5 人员能力要求与培训......................................................................................41 8.6 设施的设计保证及运行管理 ...........................................................................41 8.7 设备检查与性能保证......................................................................................42 8.8 个体防护装备.................................................................................................42 8.9 职业健康保健服务..........................................................................................43 8.10 职业健康安全信息沟通.................................................................................43 8.11 职业健康安全绩效监测.................................................................................43 附录 A（规范性附录）IACUC 的职责与管理要求 .....................................................44 附录 B（资料性附录）动物使用的减少、优化和替代原则 ........................................47
CNAS-CL60
实验动物饲养和使用机构质量和能力认可准则
Accreditation criteria for the quality and competence of laboratory animal institutions for care and using
2017 年6月1日 实施
2017 年6月1日发布 目 次 前言............................................................................................................................4 引言............................................................................................................................5 1 范围 ........................................................................................................................6 2 规范性引用文件 ......................................................................................................6 3 术语与定义 ..............................................................................................................6 4 管理体系 .................................................................................................................7 4.1 组织和管理.....................................................................................................7 4.2 人员要求 ......................................................................................................10 4.3 管理体系文件...............................................................................................10 4.4 管理手册 ......................................................................................................10 4.5 程序文件 ...................................................................................................... 11 4.6 说明及操作规程 ........................................................................................... 11 4.7 安全手册 ...................................................................................................... 11 4.8 记录 ............................................................................................................. 11 4.9 标识系统 ......................................................................................................12 4.10 文件控制 ....................................................................................................12 4.11 工作计划 ....................................................................................................13 4.12 检查 ...........................................................................................................13 4.13 不符合项的识别和控制...............................................................................14 4.14 纠正措施 ....................................................................................................14 4.15 预防措施 ....................................................................................................15 4.16 持续改进 ....................................................................................................15 4.17 内部审核 ....................................................................................................15 4.18 管理评审 ....................................................................................................15 4.19 应急管理和事故报告 ..................................................................................16 5 实验动物设施........................................................................................................17 5.1 规划与设计 ....................................................................................................17 5.2 建造要求........................................................................................................20 5.2.1 总则........................................................................................................20 5.2.2 走廊........................................................................................................20 5.2.3 围护结构.................................................................................................20 5.2.4 通风和空调 .............................................................................................21 5.2.5 给水和排水 .............................................................................................22 5.2.6 污物处理和消毒灭菌...............................................................................22 5.2.7 电力和照明 .............................................................................................23 5.2.8 通讯........................................................................................................23 5.2.9 自控、监视和报警 ...................................................................................23 5.2.10 存储区 ..................................................................................................24 5.2.11 洗刷和消毒 ...........................................................................................24 5.2.12 手术室 ..................................................................................................24 5.2.13 水生动物饲养室....................................................................................25 5.2.14 其它特殊用途的设施.............................................................................26 5.2.15 室内饲养笼具........................................................................................26 5.2.16 室外饲养房舍.........................................................................................26 6 动物饲养................................................................................................................26 6.1 总则................................................................................................................26 6.2 环境控制与监测 .............................................................................................27 6.3 动物行为管理..................................................................................................27 6.4 动物身份识别..................................................................................................28 6.5 动物遗传学特性监测和基因操作 .....................................................................28 6.6 动物营养与卫生 .............................................................................................29 6.7 饲养环境的卫生 .............................................................................................30 6.8 废物管理........................................................................................................30 6.9 假日期间动物的管理......................................................................................31 7 动物医护 ...............................................................................................................31 7.1 采购动物.........................................................................................................31 7.2 包装与运输动物..............................................................................................31 7.3 动物疾病预防与控制.......................................................................................32 7.3.1 总则........................................................................................................32 7.3.2 检疫与隔离 .............................................................................................33 7.3.3 疾病监视和监测......................................................................................33 7.3.4 疾病控制.................................................................................................34 7.3.5 动物的生物安全......................................................................................34 7.4 动物疾病治疗与护理......................................................................................34 7.4.1 总则........................................................................................................34 7.4.2 手术及护理 .............................................................................................35 7.4.2.1 手术计划..............................................................................................35 7.4.2.2 术前准备..............................................................................................35 7.4.2.3 麻醉与镇痛 ..........................................................................................36 7.4.2.4 手术.....................................................................................................36 7.4.2.5 术中监护..............................................................................................36 7.4.2.6 术后观察和护理...................................................................................37 7.4.3 疼痛与痛苦 .................................................................................................37 7.4.4 急救............................................................................................................37 7.4.5 安死术.........................................................................................................37 7.4.6 人道终止时机..............................................................................................38 7.4.7 病历............................................................................................................38 8 职业健康安全........................................................................................................38 8.1 总则................................................................................................................38 8.2 风险评估.........................................................................................................40 8.3 危险源管理与控制...........................................................................................40 8.4 员工行为规范.................................................................................................41 8.5 人员能力要求与培训......................................................................................41 8.6 设施的设计保证及运行管理 ...........................................................................41 8.7 设备检查与性能保证......................................................................................42 8.8 个体防护装备.................................................................................................42 8.9 职业健康保健服务..........................................................................................43 8.10 职业健康安全信息沟通.................................................................................43 8.11 职业健康安全绩效监测.................................................................................43 附录 A（规范性附录）IACUC 的职责与管理要求 .....................................................44 附录 B（资料性附录）动物使用的减少、优化和替代原则 ........................................47
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