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BSI 22/30456450 DC 2022

BSI 22/30456450 DC 2022

$13.70

BS EN ISO 8637-2. Extracorporeal systems for blood purification – Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators

Published By Publication Date Number of Pages
BSI 2022 34
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PDF Catalog

PDF Pages PDF Title
7 Foreword
8 Introduction
9 1 Scope
2 Normative references
10 3 Terms and definitions
15 4 Requirements
4.1 Biological safety
4.2 Sterility
4.3 Non-pyrogenicity
4.4 Mechanical characteristics
4.4.1 Structural integrity
4.4.2 Connectors to haemodialyser, haemodiafilter or haemofilter
17 4.4.3 Connectors to vascular access device
4.4.4 Connectors to ancillary components
4.4.5 Colour coding
19 4.4.6 Access ports
4.4.7 Extracorporeal circuit blood volume
4.4.8 Air capture chamber fill level
4.4.9 Transducer protectors
4.5 Functional characteristics
4.5.1 Blood pump performance
20 4.5.2 Dialysis fluid pump performance
4.5.3 Net fluid removal
4.5.4 Substitution fluid flow rate
4.5.5 Dialysis fluid composition
4.5.6 Dialysis fluid temperature
4.5.7 Substitution fluid temperature
21 4.5.8 Fluid path occlusion
4.5.9 Prevention of air infusion
4.5.10 Pressure monitoring
4.5.11 Haemocompatibility
4.5.12 Blood leak detection
5 Expiry date
22 6 Test methods
6.1 General
6.2 Biological safety and haemocompatibility
6.3 Sterility
6.4 Non-pyrogenicity
23 6.5 Mechanical characteristics
6.5.1 Structural integrity
6.5.2 Connectors to haemodialyser, haemodiafilter or haemofilter
27 6.5.3 Connector to vascular access device
6.5.4 Connectors to ancillary components
6.5.5 Colour coding
6.5.6 Access ports
28 6.5.7 Blood pathway volume
6.5.8 Air capture chamber fill level
6.5.9 Transducer Protectors
29 6.6 Functional Characteristics
6.6.1 Blood pump performance
6.6.2 Dialysis fluid pump performance
6.6.3 Net fluid removal
6.6.4 Substitution fluid flow rate
6.6.5 Dialysis fluid composition
6.6.6 Dialysis fluid temperature
6.6.7 Substitution fluid temperature
6.6.8 Fluid path occlusion
6.6.9 Prevention of air infusion
6.6.10 Pressure monitoring
30 6.6.11 Blood leak detection
7 Expiry date
8 Labelling
8.1 Labelling on the disposable
8.2 Labelling on unit protective packaging
31 8.3 Labelling on the outer shipping container
8.4 Information to be given in the accompanying documentation
33 9 Packaging
34 Bibliography

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BSI 22/30456450 DC 2022
$13.70