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现行 AAMI ST58:2013/(R)2018
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Chemical sterilization and high-level disinfection in health care facilities 医疗设施中的化学灭菌和高级消毒
发布日期: 2013-08-21
本推荐规程提供了液体化学消毒剂(LCS)/高级消毒剂(HLD)和气体化学消毒剂的选择和使用指南,这些消毒剂已被美国食品和药物管理局批准用于医院和其他医疗保健设施的营销。本推荐规程的范围包括化学灭菌和高级消毒处理区域的功能和物理设计标准;员工资格、教育和其他人事考虑;选择LCS/HLD和气体化学灭菌器的标准; 使用LCS/HLD和气体化学灭菌器时的安全性和有效性考虑;准备通过化学灭菌或高级消毒进行处理的设备;质量控制方法;以及质量流程改进。还提供了术语定义和资料性附录。
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.
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