Medical Device Sterilization 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.

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