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BS EN ISO 8637-2:2024

BS EN ISO 8637-2:2024

$167.15

Extracorporeal systems for blood purification – Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators

Published By Publication Date Number of Pages
BSI 2024 36
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This document specifies requirements for disposable extracorporeal blood and fluid circuits and accessories used in combination with haemodialysis equipment intended for extracorporeal blood treatment therapies such as, but not limited to, haemodialysis, haemodiafiltration, haemofiltration. This document does not apply to: —     haemodialysers, haemodiafilters or haemofilters; —     plasmafilters; —     haemoperfusion devices; —     vascular access devices. NOTE 1        Requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators are specified in ISO 8637-1. NOTE 2        Requirements for plasmafilters are specified in ISO 8637-3.

PDF Catalog

PDF Pages PDF Title
2 undefined
4 European foreword
Endorsement notice
7 Foreword
8 Introduction
9 1 Scope
2 Normative references
10 3 Terms and definitions
14 4 Requirements
4.1 General
4.2 Biological safety and haemocompatibility
4.3 Sterility
15 4.4 Non-pyrogenicity
4.5 Mechanical characteristics
4.5.1 Structural integrity
4.5.2 Connectors to haemodialyser, haemodiafilter or haemofilter
18 4.5.3 Connectors to vascular access device
4.5.4 Connectors to ancillary components
4.5.5 Colour coding
4.5.6 Access ports
19 4.5.7 Blood pathway volume
4.5.8 Air capture chamber fill level
4.5.9 Transducer protectors
4.6 Functional characteristics
4.6.1 General
4.6.2 Blood pump system performance
20 4.6.3 Dialysis fluid pump performance
4.6.4 Net fluid removal
4.6.5 Substitution fluid flow rate
4.6.6 Dialysis fluid composition
4.6.7 Dialysis fluid temperature
4.6.8 Substitution fluid temperature
4.6.9 Fluid path occlusion
21 4.6.10 Prevention of air infusion
4.6.11 Pressure monitoring
4.6.12 Blood leak detection
4.7 Expiry date
5 Test methods
5.1 General
22 5.2 Biological safety and haemocompatibility
5.3 Sterility
5.4 Non-pyrogenicity
5.5 Mechanical characteristics
5.5.1 Structural integrity
23 5.5.2 Connectors to haemodialyser, haemodiafilter or haemofilter
28 5.5.3 Connectors to vascular access device
5.5.4 Connectors to ancillary components
5.5.5 Colour coding
29 5.5.6 Access ports
5.5.7 Blood pathway volume
5.5.8 Air capture chamber fill level
5.5.9 Transducer protectors
30 5.6 Functional characteristics
5.6.1 General
5.6.2 Blood pump system performance
5.6.3 Dialysis fluid pump performance
5.6.4 Net fluid removal
5.6.5 Substitution fluid flow rate
5.6.6 Dialysis fluid composition
5.6.7 Dialysis fluid temperature
5.6.8 Substitution fluid temperature
31 5.6.9 Fluid path occlusion
5.6.10 Prevention of air infusion
5.6.11 Pressure monitoring
5.6.12 Blood leak detection
5.7 Expiry date
6 Labelling
6.1 Labelling on the device
6.2 Labelling on unit protective packaging
32 6.3 Labelling on the outer shipping container
6.4 Information to be given in the accompanying documentation
34 7 Packaging
35 Bibliography

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BS EN ISO 8637-2:2024
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