DIN EN ISO 11135:2012 卫生保健品灭菌.环氧乙烷.医疗设备灭菌过程的制定、确认和常规控制的要求(ISO/DIS 11135-2012).德文版本prEN ISO 11135-2012
Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/DIS 11135:2012); German version prEN ISO 11135:2012