Overview

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, and haemofiltration. This document does not apply to: - haemodialysers, haemodiafilters or haemofilters; - plasmafilters; - haemoperfusion devices; - vascular access devices. The requirements specified in this document for the extracorporeal blood and fluid circuits will help to ensure safety and satisfactory function. It was not found practicable to specify materials of construction. The dimensions of the connectors intended for connecting the extracorporeal blood and fluid circuits to a haemodialyser, haemodiafilter or haemofilter have been reviewed to ensure compatibility with these devices, as specified in ISO 8637-1. The design and dimensions selected are intended to minimize the risk of leakage of blood and ingress of air. Connectors with either fixed or loose locking shells are permitted. The responsible national standardization committee is Working Committee NA 063-01-03 AA "Extrakorporaler Kreislauf, Apparate und Einmalartikel" ("Extracorporeal circuits, equipment and disposables") at DIN Standards Committee Medicine (NAMed).

Document: references 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