Overview

This draft European Standard provides test methods and values for sealable adhesive coated paper manufactured from paper complying with EN 868-6, used as sterile barrier systems and/or packaging systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use. The materials specified in this part are intended to be used for ethylene oxide or irradiation sterilization. The need for a protective packaging may be determined by the manufacturer and the user. This part of EN 868 only introduces performance requirements and test methods that are specific to the products covered by this part of EN 868 but does not add or modify the general requirements specified in EN ISO 11607-1. This standard has been prepared by CEN/TC 102 "Sterilizers for medical purposes" (secretariat: DIN, Germany). Working Committee NA 063-04-04 AA "Sterilgutversorgung" ("Sterile supply") of DIN Standards Committee Medicine (NAMed) at the German Institute for Standardization e. V. is responsible for this standard.

Document: references other documents

Document: referenced in other documents

Responsible national committee

NA 176-03-07 AA - Sterile supply  

Responsible european committee

CEN/TC 102/WG 4 - Packaging