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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