ISO/AWI 22246

Packaging for non-sterile medical devices — Requirements for packaging systems

Scope

This international standard 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 packaging for terminally sterilized medical devices 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.
It does not apply to the maintenance of a certain microbiological state which would require integrity and microbial barrier properties.

[Note: Some changes have been made to the Scope in response to the comments received in the first NWI ballot for ISO/NP 22246.]