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BS EN ISO 22413:2021

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
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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

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BS EN ISO 22413:2021
$142.49