Medical Device Sterilization Requirements

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.

Medical device sterilization requirements.

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. 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. 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.

However since 1950 there has been an increase in medical devices and instruments made of materials e g plastics that require low temperature sterilization. Most medical and surgical devices used in healthcare facilities are made of materials that are heat stable and therefore undergo heat primarily steam sterilization.