I.S. EN ISO 11607-1:2017

National Foreword
European foreword
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Materials and preformed sterile barrier systems
6 Design and development requirements for packaging
  systems
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
Annex ZA (informative) - Relationship between this European
         Standard and the essential requirements of
         Directive 93/42/EEC [OJ L 169] aimed to be
         covered
Annex ZB (informative) - Relationship between this European
         Standard and the essential requirements of
         Directive 90/385/EEC [OJ L 189] aimed to be
         covered
Annex ZC (informative) - Relationship between this European
         Standard and the essential requirements of
         Directive 98/79/EC [OJ L 331] aimed to be
         covered

Defines 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.