The New ISO 11607-01 Standard Impacts Package Validation
Karen Sams
ISO 11607, the foremost guidance document for validating packaging for terminally sterilized medical devices, has been revised. The new ISO 11607-01 standard contains new compliance requirements for medical device manufacturers and package engineers.
Clause 6 is the most affected part of the standard. This is the clause that addressses the package’s ability to deliver a medical device to the patient without jeopardizing sterility or incurring defect. An entire section has been added to Clause 6 to address the requirements for sterile fluid pathways.
The revisions to ISO 11607 also affect the following:
- Test Methods
- Sampling Plans
