04/30101211 DC : DRAFT APR 2004

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
  4.1 General
  4.2 Quality systems
  4.3 Test methods
  4.4 Documentation
5 Material and preformed sterile barrier systems
  5.1 General requirements
  5.2 Microbial barrier properties
  5.3 Compatibility with the sterilization process
  5.4 Compatibility with the labelling system
  5.5 Storage and transport
6 Design and development requirements for packaging systems
  6.1 General
  6.2 Design
  6.3 Packaging system performance testing
  6.4 Stability testing
Annex A (informative) Guidance on medical packaging
      A.1 Factors influencing the choice of the materials and design
          of the packaging system
      A.2 Sterilization processes and considerations
      A.3 Sterile barrier systems
Annex B (informative) Standardized test methods and procedures
        that may be used to demonstrate compliance with requirements
        of ISO 11607-1
      B.1 General
      B.2 Packaging materials and preformed sterile barrier systems
      B.3 Sterile barrier systems
Annex C (normative) Test method for resistance of impermeable
        materials to passage of air
Bibliography
Annex ZA (informative) Relationship between this International
         Standard and the Essential Requirements of EU Directive
         93/42/EEC on medical devices