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BS EN ISO 11607-1:2020+A11:2022

BS EN ISO 11607-1:2020+A11:2022

$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 2022 66
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PDF Catalog

PDF Pages PDF Title
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8 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
11 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
13 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
16 Foreword
17 Introduction
19 1 Scope
2 Normative references
3 Terms and definitions
24 4 General requirements
4.1 Quality systems
4.2 Risk management
4.3 Sampling
4.4 Test methods
25 4.5 Documentation
5 Materials, preformed sterile barrier systems and sterile barrier systems
5.1 General requirements
28 5.2 Microbial barrier properties
29 5.3 Compatibility with the sterilization process
5.4 Labelling system
5.5 Storage and transport of materials and preformed sterile barrier systems
30 6 Design and development for packaging systems
6.1 General
6.2 Design
31 7 Usability evaluation for aseptic presentation
32 8 Packaging system performance and stability
8.1 General
8.2 Packaging system performance testing
33 8.3 Stability testing
9 Packaging system validation and changes
34 10 Inspection immediately prior to aseptic presentation
11 Information to be provided
35 Annex A (informative) Guidance on medical packaging
38 Annex B (informative) Standardized test methods, guides and procedures that can be used to demonstrate conformity with the requirements of this document
49 Annex C (normative) Test method for resistance of impermeable materials to the passage of air
50 Annex D (informative) Environmental aspects
51 Annex E (informative) Draft guidance on ways to differentiate a sterile barrier system from protective packaging
56 Bibliography

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BS EN ISO 11607-1:2020+A11:2022
$198.66