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BS EN ISO 8637-2:2024 – TC

BS EN ISO 8637-2:2024 – TC

$217.84

Tracked Changes. 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 83
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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
48 undefined
50 European foreword
Endorsement notice
53 Foreword
54 Introduction
55 1 Scope
2 Normative references
56 3 Terms and definitions
60 4 Requirements
4.1 General
4.2 Biological safety and haemocompatibility
4.3 Sterility
61 4.4 Non-pyrogenicity
4.5 Mechanical characteristics
4.5.1 Structural integrity
4.5.2 Connectors to haemodialyser, haemodiafilter or haemofilter
64 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
65 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
66 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
67 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
68 5.2 Biological safety and haemocompatibility
5.3 Sterility
5.4 Non-pyrogenicity
5.5 Mechanical characteristics
5.5.1 Structural integrity
69 5.5.2 Connectors to haemodialyser, haemodiafilter or haemofilter
74 5.5.3 Connectors to vascular access device
5.5.4 Connectors to ancillary components
5.5.5 Colour coding
75 5.5.6 Access ports
5.5.7 Blood pathway volume
5.5.8 Air capture chamber fill level
5.5.9 Transducer protectors
76 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
77 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
78 6.3 Labelling on the outer shipping container
6.4 Information to be given in the accompanying documentation
80 7 Packaging
81 Bibliography

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BS EN ISO 8637-2:2024 - TC
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