DS/EN 868-8:2009
Packaging for terminally sterilized medical devices - Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods

Standard No.

DS/EN 868-8:2009

Release Date

2009

Published By

Danish Standards Foundation

Latest

DS/EN 868-8:2009

Replace

DS/EN 868-8-1999

Scope

This part of EN 868 provides test methods and values for re-usable containers used as sterile barrier systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use. These containers are intended to be used in steam sterilizers conforming to EN 285.NOTE 1 The need for a packaging material inside the container is determined by the manufactures and users.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 nor modify the general requirements specified in EN ISO 11607-1.As such, the particular requirements in

DS/EN 868-8:2009 history

• 2009 DS/EN 868-8:2009 Packaging for terminally sterilized medical devices - Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods