ISO 8637-3:2024

Extracorporeal systems for blood purification — Part 3: Plasmafilters

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.

Edition	2024
Standard Part No	3
Published Date	2024
Published By	International Standardization Organisation
Page Count	18