BS EN 868-1:1997

1 Scope
2 Normative references
3 Definitions
4 Requirements
5 Test methods
6 Documentation
7 Information
Annex A (informative) Guidance on clause 4
Annex B (informative) Microbial barrier evaluation scheme
Annex C (informative) Air impermeability - Test methods
Annex D (informative) Microbial barrier properties -
        Test methods for materials
Annex E (informative) Microbial barrier properties -
        Test methods for permeable closures (filter assembly,
        tortuous path)
Annex F (informative) Impermeability and continuity of seals
        formed by fusion or adhesion - Test methods
Annex G (informative) Impermeability of seals not formed by
        fusion or adhesion - Test methods - Test procedure
        for rigid containers
Annex H (informative) Bibliography
Annex ZA (informative) Clauses of this European Standard
        addressing essential requirements or other provision
        of EU Directives

Defines requirements and methods of test for packaging materials and systems for medical devices for terminal sterilization and for maintenance of sterility of the device.