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BS ISO 8637-3:2024

BS ISO 8637-3:2024

$142.49

Extracorporeal systems for blood purification – Plasmafilters

Published By Publication Date Number of Pages
BSI 2024 28
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PDF Catalog

PDF Pages PDF Title
2 undefined
6 Foreword
7 Introduction
9 1 Scope
2 Normative references
10 3 Terms and definitions
11 4 Requirements
4.1 Biological safety and haemocompatibility
4.2 Sterility
4.3 Non-pyrogenicity
4.4 Mechanical characteristics
4.4.1 Structural integrity
4.4.2 Blood compartment integrity
12 4.4.3 Connectors
13 4.5 Performance characteristics
4.5.1 Plasma filtration rate
14 4.5.2 Sieving coefficient
4.5.3 Blood compartment volume
4.5.4 Blood compartment pressure drop
4.5.5 Haemolytic characteristics
4.6 Expiry date
5 Test methods
5.1 General
15 5.2 Biological safety and haemocompatibility
5.3 Sterility
5.4 Non-pyrogenicity
5.5 Mechanical characteristics
5.5.1 Structural integrity
5.5.2 Blood compartment integrity
16 5.5.3 Connectors
19 5.6 Performance characteristics
5.6.1 Test solution
5.6.2 Plasma filtration rate — Test procedure
5.6.3 Sieving coefficient
21 5.6.4 Blood compartment volume
5.6.5 Blood compartment pressure drop
5.6.6 Haemolytic characteristics
22 5.7 Expiry date
6 Labelling
6.1 Labelling on the device
23 6.2 Labelling on unit containers
6.3 Labelling on the outer containers
24 6.4 Information to be given in the accompanying documentation
25 7 Packaging
26 Bibliography

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BS ISO 8637-3:2024
$142.49