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.

Medical device sterilization requirements.

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. In july packaging and sterilization experts explored the complex relationship between sterile medical device packaging and sterilization methods in the webinar sterile barrier packaging. Most medical and surgical devices used in healthcare facilities are made of materials that are heat stable and therefore undergo heat primarily steam sterilization. Medical devices made.

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. For example a regulatory authority in the region in which you supply medical devices demands ethylene oxide sterilization for a specific medical device so you have to ensure.