BS EN ISO 11607-1:2020
$198.66
Packaging for terminally sterilized medical devices – Requirements for materials, sterile barrier systems and packaging systems
| Published By | Publication Date | Number of Pages |
| BSI | 2020 | 56 |
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 2 | undefined |
| 5 | European foreword Endorsement notice |
| 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 4.3 Sampling 4.4 Test methods |
| 19 | 4.5 Documentation 5 Materials, preformed sterile barrier systems and sterile barrier systems 5.1 General requirements |
| 22 | 5.2 Microbial barrier properties |
| 23 | 5.3 Compatibility with the sterilization process 5.4 Labelling system 5.5 Storage and transport of materials and preformed sterile barrier systems |
| 24 | 6 Design and development for packaging systems 6.1 General 6.2 Design |
| 25 | 7 Usability evaluation for aseptic presentation |
| 26 | 8 Packaging system performance and stability 8.1 General 8.2 Packaging system performance testing |
| 27 | 8.3 Stability testing 9 Packaging system validation and changes |
| 28 | 10 Inspection immediately prior to aseptic presentation 11 Information to be provided |
| 29 | Annex A (informative) Guidance on medical packaging |
| 32 | Annex B (informative) Standardized test methods, guides and procedures that can be used to demonstrate conformity with the requirements of this document |
| 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| 45 | Annex E (informative) Draft guidance on ways to differentiate a sterile barrier system from protective packaging |
| 50 | Bibliography |
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