ISO/NP 22246

Packaging for non-sterile medical devices — Requirements for packaging systems ISO/NP 22246

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.