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This document specifies requirements and test methods for the design and performance of packaging systems used for transporting medical devices provided non-sterile to the point of use.
Product designed and developed to be shipped non-sterile from the manufacturer is covered by the requirements in this document.
It does not apply to product sterilized within sterile barrier systems which are covered by ISO 11607-1/-2.
It does not apply to packaging materials and/or systems used to contain a contaminated medical device during transportation of the item to the site of reprocessing or disposal.
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This document specifies requirements and test methods for the design and performance of packaging systems used for transporting medical devices provided non-sterile to the point of use.
Product designed and developed to be shipped non-sterile from the manufacturer is covered by the requirements in this document.
It does not apply to product sterilized within sterile barrier systems which are covered by ISO 11607-1/-2.
It does not apply to packaging materials and/or systems used to contain a contaminated medical device during transportation of the item to the site of reprocessing or disposal.
