AAMI ISO 11607-1 : 2006
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS, AND PACKAGING SYSTEMS
Hardcopy , PDF
04-06-2019
01-01-2010
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
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