DANSK DSF/PREN ISO 11135 PDF

This document specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices in both the industrial and health care facility settings, and it acknowledges the similarities and differences between the two applications. NOTE 1 – Among the similarities are the common need for quality systems, staff training, and proper safety measures. The major differences relate to the unique physical and organizational conditions in health care facilities, and to the initial condition of reusable medical devices being presented for sterilization. NOTE 2 – Health care facilities differ from medical device manufacturers in the physical design of processing areas, in the equipment used, and in the availability of personnel with adequate levels of training and experience. The primary function of the health care facility is to provide patient care; medical device reprocessing is just one of a myriad of activities that are performed to support that function. NOTE 3 – In terms of the initial condition of medical devices, medical device manufacturers generally sterilize large numbers of similar single-use medical devices. Health care facilities, on the other hand, handle and process both new medical devices and reusable medical devices of different types and with varying levels of bioburden. They are therefore faced with the additional challenges of cleaning, evaluating, preparing and packaging a medical device prior to sterilization. In this document, alternative approaches and guidance specific to health care facilities are identified as such. NOTE 4 – EO gas and its mixtures are effective sterilants for medical devices that are sensitive other modalities such as moist heat and ionizing radiation