NEN EN 868-5 : 2009

Foreword
Introduction
1 Scope
2 Normative references
3 Definitions
4 Requirements
Annex A (normative) Method for the determination of
                      resistance to the sterilisation
                      process
Annex B (normative) Method for the determination of
                      pinholes in plastic laminate
Annex C (normative) Method for the determination of
                      peel characteristics of paper/
                      plastic laminate products
Annex D (normative) Method for the determination of
                      the strength of the heat seal
                      joint for pouches and reel
                      material
Annex E (normative) Method for the determination of
                      fibre orientation
Annex F (informative) Dimensions and tolerances
Annex G (informative) Bibliography

Defines 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.