AAMI ISO 11607-1 : 2006 : R2010

Glossary of equivalent standards
Committee representation
Background of AAMI Adoption of ISO 11607-1:2006
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
  4.1 General
  4.2 Quality systems
  4.3 Sampling
  4.4 Test methods
  4.5 Documentation
5 Materials 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
7 Information to be provided
Annex A (informative) Guidance on medical packaging
Annex B (informative) Standardized test methods and
        procedures that may be used to demonstrate
        compliance with the requirements of this part
        of ISO 11607
Annex C (normative) Test method for resistance of
        impermeable materials to the passage of air
Bibliography

Describes the requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of terminally sterilized medical devices until the point of use.