近年来,随着灭菌理论的不断深入,压力蒸汽灭菌监测技术也有了很大的发展。由于灭菌过程的特殊性,其不能够通过直接、非破坏性的方法直接进行质量检验,需要从间接的角度来建立质量控制体系。而通过认证建立起来的,模拟“最坏情况”的过程挑战装置(Process In recent years, with the continuous deepening of sterilization theory, pressure steam sterilization monitoring technology has also been greatly developed. Due to the particularity of the sterilization process, it can not directly carry out quality inspection through direct and non-destructive methods, and it is necessary to establish a quality control system indirectly. The certified “worst-case” process challenge device (Process)