Approval and publication of a revised ISO 11607 standard was expected this month, incorporating the provisions of the EN 868-1 standard. (Part I of II)
The International Standards Organization (ISO) 11607 standard is the foremost guidance document for validating packaging for terminally sterilized medical devices. Packaging must comply with ISO 11607 to ensure that the enclosed medical device is kept sterile throughout manufacturing, shipping, and storage environments.
Medical device manufacturers and packaging professionals should take note of the upcoming revisions to the ISO 11607 standard, as the revisions could mean the difference between pass or fail when it comes to package validation. Many terms have been added or eliminated from the current standard, including the following:
• The definition of "medical device." ISO 11607-01 includes some medical devices that were not previously covered by the old standard.
• "Primary package" is replaced by "sterile barrier system," defined as the "minimum package that prevents ingress of microorganisms and allows aseptic presentation of the product at the point of end use."
• "Final package" is replaced by "package system," defined as "[the] combination of the sterile barrier system and protective package." This combined package could include the second sterile barrier, or outer package, in a dual pouch or tray; a paperboard carton or shelf box; and the shipping container. These all may combine to form the "package system."
• The elimination of "package integrity," which was defined as "unimpaired physical condition of a final package." Now it is implied that package integrity is lost if the sterile barrier system is breached or does not "prevent the ingress of microorganisms to the product."
Test methods
Test data will only be accepted from ISO 11607 validated test methods, which include a Precision and Bias statement, based on round robin testing of the test method itself. A test method developed by an individual company could be used to test a specific attribute of the material or package.
However, that method must be validated by determining its precision and bias against a "standard." The validation must be documented and retained as evidence.
For more information on how ISO 11607 revisions may affect you, listen to the DDL on-demand webinar.
--By Patrick J. Nolan
Patrick J. Nolan is COO of DDL Inc., a package, product, and material testing lab. He is part of the Task Group within the AAMI Sterilization Packaging Working Group that developed the revised Technical Information Report for the ISO 11607 revisions.
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