What is ISO 11607?

ISO 11607 is a guidance document for validating terminally sterilized devices and is designed to hold suppliers, manufacturers, sterilizers and distribution vendors accountable for a safe and repeatable outcome for patients. The process consists of an intensive replication of the distribution and storage environments with establishment and comparison of strength and sterility of the packaging. Packaged products meeting acceptance criteria of a properly designed protocol produce confidence levels required for ethical and legal shipping and shelf life claims, exceed regulatory expectations and are completed on time and on budget.