Skip to main content
Back

ISO 8637-3:2024

Extracorporeal systems for blood purification — Part 3: Plasmafilters

General information

Valid from 31.05.2024
Directives or regulations
None

Standard history

Status
Date
Type
Name
31.05.2024
Main
17.07.2018
Main
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.

Required fields are indicated with *

*
*
*
PDF
127.59 € incl tax
Paper
127.59 € incl tax
Standard monitoring

Customers who bought this item also bought

Main

EVS-EN ISO 8637-2:2024

Extracorporeal systems for blood purification - Part 2: Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637-2:2024)
Newest version Valid from 02.05.2024
Main

EVS-EN ISO 80369-20:2024

Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods (ISO 80369‑20:2024)
Newest version Valid from 16.12.2024