《 ANSI/AAMI ST79:2006 -- Comprehensive guide to steam sterilization and sterility assurance in health care facilities，医疗机构中蒸汽灭菌和无菌保障的行为指南》
2009-09-30
2006年底，美国ANSI/AAMI出版了国家标准《 ANSI/AAMI ST79:2006 -- Comprehensive guide to steam sterilization and sterility assurance in health care facilities，医疗机构中蒸汽灭菌和无菌保障的行为指南》
This recommended practice covers steam sterilization in health care facilities. The recommendations are intended to promote assurance of sterility and to guide health care personnel in the proper use of processing equipment. Included within the scope of the recommended practice are functional and physical design criteria for sterilization processing areas (decontamination, preparation, sterilization, and sterile storage areas); staff qualifications, education, and other personnel considerations; processing procedures; installation, care, and maintenance of steam sterilizers; quality control; and quality process improvement. 本标准覆盖了医疗机构蒸汽灭菌工作中的实践，目标是指导工作人员能正确使用相关设备，同时给出了在各工作区域（去污区，包装准备，灭菌和无菌存放区域），还有人员资格认证，教育培训等方面的要求。对于设备运行，本标准也提出了从安装到维护，验证等方面的内容指南。
结合ISO 17665 Sterilization of health care products — Moist heat — Requirements for development, validation and routine control of a sterilization process for medical devices, 《医疗保健产品灭菌-湿热灭菌- 确认和常规控制要求》，我们消毒和感控专业人员能有更清晰的管理思路。