EN 868-8:2009

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Information to be supplied by the manufacturer
6 Test methods
Annex A (informative) - Details of significant technical
                        changes between this European
                        Standard and the previous edition
Annex B (informative) - Guidance on dimensions
Annex C (normative) - Handle strength test
Annex D (normative) - Stacking test
Annex E (normative) - Stacking device capability test
Annex F (normative) - Determination of sterilization
                      performance
Annex G (normative) - Load dryness tests
Annex H (informative) - Guidance on determination of useful
                        life
Bibliography

This part of EN 868 provides test methods and values for re-usable containers used as sterile barrier systemsthat are intended to maintain sterility of terminally sterilized medical devices to the point of use. Thesecontainers 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 theproducts covered by this part of EN 868 but does not add nor modify the general requirements specified inEN ISO 11607-1.As such, the particular requirements in 4.2 to 4.5 can be used to demonstrate compliance with one or morebut not all of the requirements of EN ISO 11607-1.NOTE 2 When it is intended to use the containers in a steam sterilizer not conforming to EN 285 the sterilization performanceof the container in the specific sterilization cycle to be used is validated by the user. Other attributes of thecontainer are also reviewed for compatibility with the sterilizer cycle e.g. operating temperature.NOTE 3 When additional materials are used inside the sterile barrier system in order to ease the organization, dryingor aseptic presentation (e.g. inner wrap, container filter, indicators, packing lists, mats, instrument organizer sets, trayliners or an additional envelope around the medical device) then other requirements, including the determination of theacceptability of these materials during validation activities, may apply.