本文件规定了液体化学杀菌剂的特性要求，以及液体化学杀菌剂对一次性医疗器械（包括全部或部分动物源性材料）杀菌的开发、验证、过程控制和监测要求。 本文件涵盖了由细菌和真菌污染引起的风险控制 液体化学灭菌工艺的应用。可使用其他方法评估与其他微生物相关的风险（见注1）。购买本文件时可获得的所有当前修订均包含在购买本文件中。

This document specifies requirements for the characterization of a liquid chemical sterilizing agent and for the development, validation, process control and monitoring of sterilization by liquid chemical sterilizing agents of single-use medical devices comprising, in whole or in part, materials of animal origin. This document covers the control of risks arising from contamination with bacteria and fungi by application of a liquid chemical sterilization process. Risks associated with other microorganisms can be assessed using other methods (see NOTE 1).All current amendments available at time of purchase are included with the purchase of this document.