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BSI 23/30470634 DC 2023

BSI 23/30470634 DC 2023

$13.70

BS ISO 8637-3. Extracorporeal systems for blood purification – Part 3. Plasmafilters

Published By Publication Date Number of Pages
BSI 2023 26
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PDF Catalog

PDF Pages PDF Title
6 Foreword
7 Introduction
9 1 Scope
2 Normative references
10 3 Terms and definitions (mandatory)
11 4 Requirements
4.1 Biological safety
4.2 Sterility
4.3 Non-pyrogenicity
4.4 Mechanical characteristics
4.4.1 Structural integrity
12 4.4.2 Blood compartment integrity
4.4.3 Plasmafilter blood compartment connectors
13 4.4.4 Filtrate compartment connector
4.5 Performance characteristics
4.5.1 Plasma filtration rate
4.5.2 Sieving coefficient
4.5.3 Blood compartment volume
14 4.5.4 Blood compartment pressure drop
4.5.5 Haemolytic characteristics
4.6 Expiry date
5 Test methods
5.1 General
5.2 Biological safety and haemocompatibility
15 5.3 Sterility
5.4 Non-pyrogenicity
5.5 Mechanical characteristics
5.5.1 Structural Integrity
5.5.2 Blood compartment integrity
5.5.3 Blood compartment connectors
18 5.5.4 Plasma filtrate compartment connectors
5.6 Performance characteristics
5.6.1 Test solution
19 5.6.2 Plasma filtration rate
5.6.3 Sieving coefficient
5.6.4 Equation for calculating sieving coefficient
21 5.6.5 Blood compartment volume
5.6.6 Blood compartment pressure drop
22 5.6.7 Haemolytic characteristics
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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BSI 23/30470634 DC 2023
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