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BS EN ISO 8536-12:2021

BS EN ISO 8536-12:2021

$102.76

Infusion equipment for medical use – Check valves for single use

Published By Publication Date Number of Pages
BSI 2021 18
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This document specifies requirements for check valves intended for single use and used with infusion equipment both with gravity-feed infusion and with pressure infusion apparatus.

The functional requirements in this document also apply to inline check valves.

PDF Catalog

PDF Pages PDF Title
2 National foreword
4 European foreword
6 Foreword
7 1 Scope
2 Normative references
3 Terms and definitions
8 4 Designation
5 Materials
6 Physical requirements
6.1 Particulate contamination
6.2 Leakage
6.3 ISO 80369 (all parts) compatibility
6.4 Counterflow pressure resistance
9 6.5 Flow rate
6.6 Blocking performance
6.7 Opening pressure
6.8 Protective caps
7 Chemical requirements
8 Biological requirements
8.1 General
8.2 Sterility
8.3 Pyrogenicity
9 Labelling
9.1 General
10 9.2 Label on unit container
9.3 Label on shelf or multi-unit container
10 Packaging
11 Disposal
11 Annex A (normative) Physical tests
17 Bibliography

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BS EN ISO 8536-12:2021
$102.76