I.S. EN ISO 11607-1:2020&LC:2020
Current
The latest, up-to-date edition.
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019)
Hardcopy , PDF
English
03-12-2020
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Materials, preformed sterile barrier systems and sterile barrier systems
6 Design and development for packaging systems
7 Usability evaluation for aseptic presentation
8 Packaging system performance and stability
9 Packaging system validation and changes
10 Inspection immediately prior to aseptic presentation
11 Information to be provided
Annex A (informative) Guidance on medical packaging
Annex B (informative) Standardized test methods, guides and procedures that can be used to demonstrate conformity with the requirements of this document
Annex C (normative) Test method for resistance of impermeable materials to the passage of air
Annex D (informative) Environmental aspects
Annex E (informative) Draft guidance on ways to differentiate a sterile barrier system from protective packaging
Bibliography
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