Draft Details

Extracorporeal systems for blood purification —Part 2: Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (New Edition)
Designation:CSA ISO 8637-2
Source:CSA
Review start date:Aug 26, 2026
Review end date:Oct 25, 2026
Contact email:robin.chevalier(at)csagroup.org
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Draft Scope/Description:

1 Scope

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.

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