DIN Standards Committee Health Technologies
DIN EN ISO 8638
Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8638:2010); German version EN ISO 8638:2014
Kardiovaskuläre Implantate und extrakorporale Systeme - Extrakorporaler Blutkreislauf bei Hämodialysatoren, Hämodiafiltern und Hämofiltern (ISO 8638:2010); Deutsche Fassung EN ISO 8638:2014
Overview
This standard specifies requirements for the extracorporeal blood circuit of haemodialysers, haemodiafilters and haemofilters. The requirements specified in this International Standard will help to ensure safety and satisfactory function of the extracorporeal blood circuit. This document does not specify materials of construction for the devices, but therefore requires only that the materials used have been tested and that the methods and results are made available upon request. The dimensions of the connectors intended for connecting the extracorporeal blood circuit to a haemodialyser, haemodiafilter or haemofilter have been specified more precisely to ensure compatibility with these devices, as specified in ISO 8637. The design and dimensions have been selected in order to minimize the risk of leakage of blood and ingress of air. This International Standard reflects the consensus of physicians, manufacturers and other interested parties for devices that are approved for clinical use. This document has been prepared by Standards Committee NA 063-01-03 AA "Extrakorporaler Kreislauf, Apparate und Einmalartikel" ("Extracorporeal circuits, equipment and disposables") at DIN.
Document: references other documents
Document: referenced in other documents
Responsible national committee
NA 176-04-06 AA - Extracorporeal circuits, equipment and disposables
Responsible european committee
CEN/TC 205 - Non-active medical devices
Responsible international committee
ISO/TC 150/SC 2/WG 5 - Renal replacement, detoxification and apheresis
