Medical Device Sterilization Requirements

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.

Medical device sterilization requirements.

However since 1950 there has been an increase in medical devices and instruments made of materials e g plastics that require low temperature sterilization. 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 devices made. 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.

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.