BS EN ISO 22413:2021
$142.49
Transfer sets for pharmaceutical preparations. Requirements and test methods
Published By | Publication Date | Number of Pages |
BSI | 2021 | 24 |
This document specifies requirements and test methods for sterilized single-use transfer sets that are used for pharmaceutical preparations.
PDF Catalog
PDF Pages | PDF Title |
---|---|
2 | National foreword |
4 | European foreword |
6 | Foreword |
7 | Introduction |
9 | 1 Scope 2 Normative references 3 Terms and definitions |
10 | 4 Design and designation 4.1 Design for transfer sets without housing |
13 | 4.2 Design for a transfer set with housing 4.3 Designation 5 Materials 6 Physical requirements 6.1 Particulate contamination 6.2 Tensile strength |
14 | 6.3 Leakage 6.4 Free flow 6.5 Piercing device 6.6 Penetration force 6.7 Fragmentation |
15 | 6.8 Air inlet and air outlet 6.9 Protective caps 6.10 Transfer sets with housing 6.11 Small-bore connectors 6.12 Fluid filter 7 Chemical requirements 8 Biological requirements 9 Packaging |
16 | 10 Labelling 10.1 General 10.2 Unit container 10.3 Shelf or multi-unit container |
17 | 11 Disposal |
18 | Annex A (normative) Physical tests |
22 | Bibliography |