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BS EN ISO 8637-2:2018

BS EN ISO 8637-2:2018

$142.49

Extracorporeal systems for blood purification – Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters

Published By Publication Date Number of Pages
BSI 2018 24
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WARNING Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this document.

This document specifies requirements for the blood circuit for devices used in extracorporeal blood filtration therapies such as, but not limited to, haemodialysis, haemodiafiltration, haemofiltration and transducer protectors (integral and non-integral) intended for use in such circuits.

This document does not apply to:

  • haemodialysers, haemodiafilters or haemofilters;

  • plasmafilters;

  • haemoperfusion devices;

  • vascular access devices;

  • blood pumps;

  • pressure monitors for the extracorporeal blood circuit;

  • air detection devices;

  • systems to prepare, maintain or monitor dialysis fluid;

  • systems or equipment intended to perform haemodialysis, haemodiafiltration, haemofiltration or haemoconcentration.

NOTE 1 Requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators are specified in ISO 8637‑1, and requirements for plasmafilters are specified in ISO 8637‑3.

NOTE 2 Extracorporeal blood tubing sets can also be used for other extracorporeal therapies such as haemoperfusion, plasmafiltration and plasma adsorption.

PDF Catalog

PDF Pages PDF Title
2 National foreword
4 European foreword
6 Foreword
7 Introduction
9 1 Scope
2 Normative references
10 3 Terms and definitions
4 Requirements
4.1 Biological safety
11 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
4.4.3 Connectors to vascular access device
4.4.4 Connectors to ancillary components
4.4.5 Colour coding
13 4.4.6 Access ports
4.4.7 Blood pathway volume
4.4.8 Air capture chamber fill level
4.4.9 Transducer protectors
4.4.10 Blood pathway flow dynamics
4.4.11 Pump segment performance
14 4.5 Expiry date
4.6 Tubing compliance
5 Test methods
5.1 General
5.2 Biological safety
5.3 Sterility
5.4 Non-pyrogenicity
15 5.5 Mechanical characteristics
5.5.1 Structural integrity
5.5.2 Connectors to haemodialyser, haemodiafilter or haemofilter
5.5.3 Connector to vascular access device
5.5.4 Connectors to ancillary components
5.5.5 Colour coding
16 5.5.6 Access ports
17 5.5.7 Blood pathway volume
5.5.8 Air capture chamber fill level
5.5.9 Transducer protectors
5.5.10 Blood pathway flow dynamics
5.5.11 Pump segment performance
18 5.6 Expiry date
5.7 Tubing compliance
19 6 Labelling
6.1 Labelling on the device
6.2 Labelling on unit containers
6.3 Labelling on the outer containers
20 6.4 Information to be given in the accompanying documentation
22 Bibliography

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BS EN ISO 8637-2:2018
$142.49