04/30101211 DC : DRAFT APR 2004
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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ISO 11607-1 - PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS
31-05-2006
23-11-2012
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
4.1 General
4.2 Quality systems
4.3 Test methods
4.4 Documentation
5 Material 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
Annex A (informative) Guidance on medical packaging
A.1 Factors influencing the choice of the materials and design
of the packaging system
A.2 Sterilization processes and considerations
A.3 Sterile barrier systems
Annex B (informative) Standardized test methods and procedures
that may be used to demonstrate compliance with requirements
of ISO 11607-1
B.1 General
B.2 Packaging materials and preformed sterile barrier systems
B.3 Sterile barrier systems
Annex C (normative) Test method for resistance of impermeable
materials to passage of air
Bibliography
Annex ZA (informative) Relationship between this International
Standard and the Essential Requirements of EU Directive
93/42/EEC on medical devices
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