Overview

This standard specifies requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators, hereinafter collectively referred to as "the device", for use in the human body. The requirements specified in this International Standard will help to ensure safety and satisfactory function of the devices. 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 blood ports and the dialysis fluid or filtrate ports have been specified more precisely to ensure compatibility of the devices with the extracorporeal blood circuit specified in ISO 8638. The design and dimensions have been selected in order to minimize the risk of leakage of blood and the 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