prBAS EN ISO 8637-2:2025
Extracorporeal systems for blood purification - Part 2: Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
General information
Status:Project
Number of pages:34
Adoption method:Proglašavanje
Language:engleski
Edition:2.
Realization date:22.10.2024
Forseen date for next stage code:12.03.2025
Technical committee:BAS/TC 25, Healthcare
ICS:
11.040.40, Implants for surgery, prosthetics and orthotics
11.040.20, Transfusion, infusion and injection equipment
11.040.20, Transfusion, infusion and injection equipment
Abstract
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.
Lifecycle
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Original document and degree of correspondence
EN ISO 8637-2:2024, identical
ISO 8637-2:2024, identical
Relation to BAS standards
Work material
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