ISO 22413:2021
Transfer sets for pharmaceutical preparations — Requirements and test methods
This document specifies requirements and test methods for sterilized single-use transfer sets that are used for pharmaceutical preparations.
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Design and designation
4.1 Design for transfer sets without housing
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
6.3 Leakage
6.4 Free flow
6.5 Piercing device
6.6 Penetration force
6.7 Fragmentation
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
10 Labelling
10.1 General
10.2 Unit container
10.3 Shelf or multi-unit container
11 Disposal
Annex A (normative) Physical tests
Bibliography
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Design and designation
4.1 Design for transfer sets without housing
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
6.3 Leakage
6.4 Free flow
6.5 Piercing device
6.6 Penetration force
6.7 Fragmentation
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
10 Labelling
10.1 General
10.2 Unit container
10.3 Shelf or multi-unit container
11 Disposal
Annex A (normative) Physical tests
Bibliography