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BS EN ISO 11607-1:2020+A1:2023

BS EN ISO 11607-1:2020+A1:2023

$215.11

Packaging for terminally sterilized medical devices – Requirements for materials, sterile barrier systems and packaging systems

Published By Publication Date Number of Pages
BSI 2023 84
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PDF Catalog

PDF Pages PDF Title
2 undefined
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10 Annex ZA (informative)Relationship between this European Standard and the essential requirements of Directive 93/42/EEC [OJ L 169] (as amended) aimed to be covered
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15 Annex ZB (informative)Relationship between this European Standard and the essential requirements of Directive 90/385/EEC [OJ L 189] (as amended) aimed to be covered
17 Annex ZC (informative)Relationship between this European Standard and the essential requirements of Directive 98/79/EC [OJ L 331] (as amended) aimed to be covered
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22 Foreword
23 Introduction
25 1 Scope
2 Normative references
3 Terms and definitions
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32 4.5 Documentation
5 Materials, preformed sterile barrier systems and sterile barrier systems
5.1 General requirements
35 5.2 Microbial barrier properties
36 5.3 Compatibility with the sterilization process
5.4 Labelling system
5.5 Storage and transport of materials and preformed sterile barrier systems
37 6 Design and development for packaging systems
6.1 General
6.2 Design
38 7 Usability evaluation for aseptic presentation
39 8 Packaging system performance and stability
8.1 General
8.2 Packaging system performance testing
40 8.3 Stability testing
9 Packaging system validation and changes
41 10 Inspection immediately prior to aseptic presentation
11 Information to be provided
42 Annex A (informative) Guidance on medical packaging
45 Annex B (informative) Standardized test methods, guides and procedures that can be used to demonstrate conformity with the requirements of this document
56 Annex C (normative) Test method for resistance of impermeable materials to the passage of air
57 Annex D (informative) Environmental aspects
58 Annex E (informative) Draft guidance on ways to differentiate a sterile barrier system from protective packaging
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77 Bibliography

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BS EN ISO 11607-1:2020+A1:2023
$215.11