An Introduction to ISO 11607 - Packaging for Terminally Sterilized Medical Devices

Sterile devices are free of viable microorganisms and the sterile barrier system is the key to maintaining this sterility until the medical device is ready to be used on a patient. Regulations for medical devices include particular requirements for devices supplied or intended to be used in a sterile state, including maintaining this state for a defined period of time. These regulatory requirements relate to general safety and performance aspects of the products, and the requirements for independent, third-party conformity assessment of the processes for achieving and maintaining sterility. Evidence of an appropriate and stable sterile barrier system is important and expected when demonstrating conformity with the regulations. 

These requirements are supported by a series of standards for maintaining sterility over time with appropriate sterile barrier systems.

This course provides an introduction to these regulatory requirements, as they relate to typical sterile barrier systems used for single-use and reusable medical devices, and how manufacturers may demonstrate compliance.