Take a Team Approach to ISO 11607
-Daphne Allen
The revised ISO 11607 standard—formally known as EN/ISO 11607:2006, Parts 1 and 2—offers medical device manufacturers (MDMs) further guidance on sterile packaging. But that is all it is—guidance. MDMs will have to make several decisions on their own.
“There are a lot of areas for interpretation in ISO 11607,” says Randy Troutman, technical director of Oliver Medical (Grand Rapids, MI). “The standard tells you what you have to do to comply, not how to do it.”
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