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.
Registration number (WIID)
87066
Scope
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.
