ISO 11607-1:2019
Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems
This document specifies 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.
It is applicable to industry, to health care facilities, and to wherever medical devices are placed in sterile barrier systems and sterilized.
It does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations.
It does not describe a quality assurance system for control of all stages of manufacture.
It does not apply to packaging materials and/or systems used to contain a contaminated medical device during transportation of the item to the site of reprocessing or disposal.
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
4.1 Quality systems
4.2 Risk management
4.3 Sampling
4.4 Test methods
4.5 Documentation
5 Materials, preformed sterile barrier systems and sterile barrier systems
5.1 General requirements
5.2 Microbial barrier properties
5.3 Compatibility with the sterilization process
5.4 Labelling system
5.5 Storage and transport of materials and preformed sterile barrier systems
6 Design and development for packaging systems
6.1 General
6.2 Design
7 Usability evaluation for aseptic presentation
8 Packaging system performance and stability
8.1 General
8.2 Packaging system performance testing
8.3 Stability testing
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Annex E (informative) Draft guidance on ways to differentiate a sterile barrier system from protective packaging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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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
4.1 Quality systems
4.2 Risk management
4.3 Sampling
4.4 Test methods
4.5 Documentation
5 Materials, preformed sterile barrier systems and sterile barrier systems
5.1 General requirements
5.2 Microbial barrier properties
5.3 Compatibility with the sterilization process
5.4 Labelling system
5.5 Storage and transport of materials and preformed sterile barrier systems
6 Design and development for packaging systems
6.1 General
6.2 Design
7 Usability evaluation for aseptic presentation
8 Packaging system performance and stability
8.1 General
8.2 Packaging system performance testing
8.3 Stability testing
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