20.00 New project registered in TC/SC work programme Jun 10, 2024
ISO
ISO/TC 122/SC 3 Performance requirements and tests for means of packaging, packages and unit loads (as required by ISO/TC 122)
International Standard
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.]
IN_DEVELOPMENT
ISO/AWI 22246
20.00
New project registered in TC/SC work programme
Jun 10, 2024