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ANSI/AAMI/ISO 11607-1:2019 - Packaging for terminally sterilized medical devices- Part 1: Requirements for materials, sterile barrier systems and packaging systems >
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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]
- 5 Materials, preformed sterile barrier systems and sterile barrier systems [Go to Page]
- 6 Design and development for packaging systems [Go to Page]
- 7 Usability evaluation for aseptic presentation
- 8 Packaging system performance and stability [Go to Page]
- 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]
- 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]
- 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- Annex E (informative) Draft guidance on ways to differentiate a sterile barrier system from protective packaging [Go to Page]
- Bibliography [Go to Page]
