Sterilized medical device packaging must assure that the contents inside are guaranteed to remain sterile until opened – from the moment it is sealed, throughout transportation, and into the consumers hands. The ISO 11607 standard provides a full guide on packaging validation – from how a package can meet this requirement, to how manufacturers can document the process.

ISO 11607-1 and ISO 11697-2

The ISO 11607 standard is conveniently split into the two following parts, covering the demands on packaging for terminally sterilized medical devices.

ISO 11607 1: Part one establishes the requirements and methods for testing the sterile barrier systems and packaging systems. To make sure that they remain terminally sterilized from factory to end user.

ISO 11607 2: Part two sets out the process requirements on a manufacturer when creating a sterile barrier system for their medical devices. What they should do to minimize any risk of contamination in the factory and through the supply chain. And how they should do it.

If you would like to learn more about ISO 11607, check out our full article explaining ISO 11607 and the medical packaging process in full details here.

You can also find out more about the products and services we offer to the Medical Device industry by checking the link here.