I.S. EN ISO 11607-1:2017&LC:2017
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
Hardcopy , PDF
29-01-2020
English
13-12-2017
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 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
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