1 Scope
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.