標準號：ANSI/AAMI ST58-2013
中文標準名稱：醫療保健設施中戊二醛基產品的安全使用和處理
英文標準名稱：Chemical sterilization and high-level disinfection in health care facilities
標準類型：C04
發布日期：2013/8/21 12:00:00
實施日期：1999/12/31 12:00:00
中國標準分類號：C04
適用范圍：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.