CEN - EN 868-2
Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods
|Publication Date:||1 February 2017|
|ICS Code (Sterilized packaging):||11.080.30|
This European Standard specifies test methods and values for materials for sterile barrier systems and/or packaging systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use.
Other than the general requirements as specified in EN ISO 11607-1 and EN ISO 11607-2 this part of EN 868 specifies materials, test methods and values that are specific to the products covered by this European Standard.
While materials specified in 220.127.116.11 to 18.104.22.168 of this part of EN 868 are intended for single use, the materials specified in 22.214.171.124 are intended for reuse.