标准号:ANSI/AAMI ST58-2013
中文标准名称:医疗保健设施中戊二醛基产品的安全使用和处理
英文标准名称:Chemical sterilization and high-level disinfection in health care facilities
标准类型:C04
发布日期:2013/8/21 12:00:00
实施日期:1999/12/31 12:00:00
中国标准分类号:C04
适用范围:This recommended practice provides guidelines for the selection and use of liquid chemical sterilants (LCSs)/high-level disinfectants (HLDs) and gaseous chemical sterilizers that have been cleared for marketing by the U.S. Food and Drug Administration for use in hospitals and other health care facilities. Included within the scope of this recommended practice are functional and physical design criteria for chemical sterilization and high-level disinfection processing areas; staff qualifications, education, and other personnel considerations; criteria for selecting LCSs/HLDs and gaseous chemical sterilizers; safety and efficacy considerations in the use of LCSs/HLDs and gaseous chemical sterilizers; preparation of devices for processing by chemical sterilization or high-level disinfection; quality control methods; and quality process improvement. Definitions of terms and informative annexes are also provided.