90.92 Standard to be revised Oct 13, 2025
ISO
ISO/TC 150/SC 2 Cardiovascular implants and extracorporeal systems
International Standard
11.040.40 Implants for surgery, prosthetics and orthotics
Published
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.
WITHDRAWN
ISO 8637-3:2018
PUBLISHED
ISO 8637-3:2024
90.92
Standard to be revised
Oct 13, 2025
IN_DEVELOPMENT
ISO/FDIS 8637-3
