Alcance
This document specifies requirements and test methods for plasmafilters, which are devices intended to separate plasma from blood in therapeutic plasmapheresis therapy. This document specifies the requirements for sterile, single-use plasmafilters, intended for use on humans, hereinafter collectively referred to as “the device”, for use in humans. This document does not apply to;— extracorporeal blood circuits;— haemodialysers, haemodiafilters, haemofilters and haemoconcentrators;— haemoperfusion devices;— vascular access devices;— blood pumps;— systems or equipment intended to perform plasma separation.NOTE 1 Requirements for the extracorporeal blood circuit are specified in ISO 8637-2.NOTE 2 Requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators are specified in ISO 8637-1.