AAMI 11607 1 2019
$93.55
ANSI/AAMI/ISO 11607-1:2019 – Packaging for terminally sterilized medical devices- Part 1: Requirements for materials, sterile barrier systems and packaging systems
| Published By | Publication Date | Number of Pages |
| AAMI | 2019 | 57 |
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
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | ANSI/AAMI/ISO 11607-1:2019; Packaging for terminally sterilized medical devices—Part 1: Requirements for materials, sterile barrier systems and packaging systems |
| 2 | Objectives and uses of AAMI standards and recommended practices |
| 3 | Title page |
| 4 | AAMI Standard Copyright information |
| 5 | Contents |
| 6 | Committee representation |
| 9 | Background of ANSI/AAMI adoption of ISO 11607-1:2019 |
| 10 | Foreword |
| 11 | Introduction |
| 13 | 1 Scope 2 Normative references 3 Terms and definitions |
| 18 | 4 General requirements 4.1 Quality systems 4.2 Risk management |
| 19 | 4.3 Sampling 4.4 Test methods 4.5 Documentation |
| 20 | 5 Materials, preformed sterile barrier systems and sterile barrier systems 5.1 General requirements |
| 23 | 5.2 Microbial barrier properties 5.3 Compatibility with the sterilization process |
| 24 | 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 |
| 25 | 6.2 Design |
| 26 | 7 Usability evaluation for aseptic presentation |
| 27 | 8 Packaging system performance and stability 8.1 General 8.2 Packaging system performance testing |
| 28 | 8.3 Stability testing 9 Packaging system validation and changes |
| 29 | 10 Inspection immediately prior to aseptic presentation 11 Information to be provided |
| 30 | Annex A (informative) Guidance on medical packaging A.1 Factors influencing the choice of the materials and design of the packaging system 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 |
| 33 | Annex B (informative) Standardized test methods, guides and procedures that can be used to demonstrate conformity with the requirements of this document B.1 General B.2 Packaging materials and preformed sterile barrier systems Table B.1—Test methods and their status |
| 43 | Annex C (normative) Test method for resistance of impermeable materials to the passage of air |
| 44 | Annex D (informative) Environmental aspects |
| 45 | Annex E (informative) Draft guidance on ways to differentiate a sterile barrier system from protective packaging |
| 47 | Table E.1—Symbols used in the initial Sterile Barrier Association Survey |
| 48 | Table E.2—Example of revised symbol proposals resulting from the Sterile Barrier Association Survey |
| 50 | Bibliography |
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