ISO/AWI 22246
Packaging for non-sterile medical devices — Requirements for packaging systems
Reference number
ISO/AWI 22246
Версия 1
Working draft
ISO/AWI 22246
Проект данного международного стандарта был подготовлен рабочей группой.


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.]

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