BS EN ISO 8637-2:2018 PDF

1   Scope

WARNING Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this document.

This document specifies requirements for the blood circuit for devices used in extracorporeal blood filtration therapies such as, but not limited to, haemodialysis, haemodiafiltration, haemofiltration and transducer protectors (integral and non-integral) intended for use in such circuits. This document does not apply to:

— haemodialysers, haemodiafilters or haemofilters;

— plasmafilters;

— haemoperfusion devices;

— vascular access devices;

— blood pumps;

— pressure monitors for the extracorporeal blood circuit ;

— air detection devices;

— systems to prepare, maintain or monitor dialysis fluid;

— systems or eq...