BS EN 868-5:2009

Foreword
Introduction
1 Scope
2 Normative references
3 Definitions
4 Requirements
5 Information to be supplied by the manufacturer
Annex A (informative) - Details of significant technical
                        changes between this European
                        Standard and the previous edition
Annex B (normative) - Method for the determination of
                      resistance to the intended
                      sterilization process
Annex C (normative) - Method for the determination of
                      pinholes in plastic laminate
Annex D (normative) - Method for the determination of
                      the strength of the seal joint for
                      pouches and reel material
Annex E (normative) - Method for the determination of
                      peel characteristics of paper/plastic
                      laminate products
Annex F (normative) - Method for the determination of
                      fibre orientation
Bibliography

Gives test methods and values for sealable pouches and reels manufactured from porous materials complying with either EN 868 part 2, 3, 6, 7, 9 or 10 and plastic film complying with Clause 4 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.

This part of EN 868 provides test methods and values for sealable pouches and reels manufactured from porous materials complying with either EN 868 part 2, 3, 6, 7, 9 or 10 and plastic film complying with Clause 4 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. NOTE 1 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. As such, the particular requirements in 4.2 to 4.5 can be used to demonstrate compliance with one or more but not all of the requirements of EN ISO 11607-1. The materials specified in this part of EN 868 are intended for single use only. NOTE 2 When additional materials are used inside the sterile barrier system in order to ease the organization, drying or aseptic presentation (e.g. inner wrap, container filter, indicators, packing lists, mats, instrument organizer sets, tray liners or an additional envelope around the medical device) then other requirements, including the determination of the acceptability of these materials during validation activities, may apply.