How do you satisfy worst-case requirements in ISO 11607?

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ISO 11607:2006, "Packaging for Terminally Sterilized Medical Devices," requires medical device manufacturers to consider the worst case when designing and validating packaging. ISO 11607 addresses "worst case" in three areas, and in each case, it means something slightly different. In order to correctly interpret and apply these clauses dealing with worst case, it is important to understand all the terms that are used.