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BS EN ISO 22413:2021 – TC:2022 Edition

BS EN ISO 22413:2021 – TC:2022 Edition

$186.33

Tracked Changes. Transfer sets for pharmaceutical preparations. Requirements and test methods

Published By Publication Date Number of Pages
BSI 2022 60
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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
38 National foreword
40 European foreword
42 Foreword
43 Introduction
45 1 Scope
2 Normative references
3 Terms and definitions
46 4 Design and designation
4.1 Design for transfer sets without housing
49 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
50 6.3 Leakage
6.4 Free flow
6.5 Piercing device
6.6 Penetration force
6.7 Fragmentation
51 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
52 10 Labelling
10.1 General
10.2 Unit container
10.3 Shelf or multi-unit container
53 11 Disposal
54 Annex A (normative) Physical tests
58 Bibliography

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BS EN ISO 22413:2021 - TC
$186.33