Standard Swedish standard · SS-EN 868-2:2017

Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods

Status: Valid

Scope
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 4.2.2.1 to 4.2.2.3 of this part of EN 868 are intended for single use, the materials specified in 4.2.2.4 are intended for reuse.

Subjects

Sterilized packaging (11.080.30) Packaging materials and accessories (55.040)


Product information

Language: English

Written by: SIS - Hälso- och sjukvård

International title:

Article no: STD-8025050

Edition: 3

Approved: 2/13/2017

No of pages: 32

Replaces: SS-EN 868-2:2009