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eLibrary > ANSI/AAMI/ISO 11607-1:2019 - Packaging for terminally sterilized medical devices- Part 1: Requirements for materials, sterile barrier systems and packaging systems >

ANSI/AAMI/ISO 11607-1:2019 - Packaging for terminally sterilized medical devices- Part 1: Requirements for materials, sterile barrier systems and packaging systems, 2019

ANSI/AAMI/ISO 11607-1:2019; Packaging for terminally sterilized medical devices—Part 1: Requirements for materials, sterile barrier systems and packaging systems
Objectives and uses of AAMI standards and recommended practices
Title page
AAMI Standard
Copyright information
Contents
Committee representation
Background of ANSI/AAMI adoption of ISO 11607-1:2019
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements [Go to Page]
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 [Go to Page]
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 [Go to Page]
6.1 General
6.2 Design
7 Usability evaluation for aseptic presentation
8 Packaging system performance and stability [Go to Page]
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 [Go to Page]
A.1 Factors influencing the choice of the materials and design of the packaging system [Go to Page]
Figure A.1—Inter-relationships influencing the choice of appropriate materials for terminally sterilizedmedical packaging systems
A.2 Sterilization processes and considerations
A.3 Sterile barrier systems
Annex B (informative) Standardized test methods, guides and procedures that can be used to demonstrate conformity with the requirements of this document [Go to Page]
B.1 General
B.2 Packaging materials and preformed sterile barrier systems [Go to Page]
Table B.1—Test methods and their status
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Annex E (informative) Draft guidance on ways to differentiate a sterile barrier system from protective packaging [Go to Page]
Table E.1—Symbols used in the initial Sterile Barrier Association Survey
Table E.2—Example of revised symbol proposals resulting from the Sterile Barrier Association Survey
Bibliography [Go to Page]

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