本文件规定了使用低温蒸汽和甲醛混合物作为杀菌剂并在环境压力下运行的医疗器械低温蒸汽和甲醛（LTSF）灭菌过程的开发、验证和常规控制要求。注:尽管本文件的范围仅限于医疗器械，但它规定了可适用于其他产品和设备的要求并提供了指导。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 development, validation and routine control of a low temperature steam and formaldehyde (LTSF) sterilization process for medical devices using a mixture of low temperature steam and formaldehyde as sterilizing agent and which operates below ambient pressure.NOTE Although the scope of this document is limited to medical devices, it specifies requirements and provides guidance that can be applicable to other products and equipment.All current amendments available at time of purchase are included with the purchase of this document.