ISO/PWI 22246

Packaging for non-sterile medical devices — Requirements for packaging systems ISO/PWI 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.
It does not apply to packaging for terminally sterilized medical devices which are covered by ISO 11607-1 and ISO 11607-2.
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.
It does not apply to the maintenance of a certain microbiological state which would require integrity and microbial barrier properties.