Medical Device Sterilization Requirements

The processes of sterilization and decontamination are complex requiring specific infrastructure equipment and process in this course which is divided into two parts you will learn about the overall procedure for managing decontamination and sterilization of medical devices.

Medical device sterilization requirements.

The impact of sterilization modalities jeremy elwell senior principal engineer for oliver healthcare packaging explored the design and development of sterile barrier systems while brian mcevoy b sc. Sterile medical device clause 3 20 of iso 13485 2016 states that sterility requirements of each medical device can be subject to applicable regulatory requirements. Most medical and surgical devices used in healthcare facilities are made of materials that are heat stable and therefore undergo heat primarily steam sterilization. If review of the device history records including process control and monitoring records acceptance activity records etc reveals that the sterilization process is outside the firm s tolerance.

For many medical devices sterilization with ethylene oxide may be the only method that effectively sterilizes and does not damage the device during the sterilization process. In july packaging and sterilization experts explored the complex relationship between sterile medical device packaging and sterilization methods in the webinar sterile barrier packaging.