ISO - FDIS 8637-2
Extracorporeal systems for blood purification — Part 2: Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
pending
| Organization: | ISO |
| Publication Date: | 19 September 2023 |
| Status: | pending |
| Page Count: | 34 |
| ICS Code (Implants for surgery, prosthetics and orthotics): | 11.040.40 |
scope:
This document specifies requirements for disposable extracorporeal blood and fluid circuits and accessories used in combination with haemodialysis equipment intended for extracorporeal blood treatment therapies such as, but not limited to, haemodialysis, haemodiafiltration, haemofiltration.
This document does not apply to:
- haemodialysers, haemodiafilters or haemofilters;
- plasmafilters;
- haemoperfusion devices;
- vascular access devices.
NOTE 1 Requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators are specified in ISO 8637-1.
NOTE 2 Requirements for plasmafilters are specified in ISO 8637-3.
Document History
FDIS 8637-2
September 19, 2023
Extracorporeal systems for blood purification — Part 2: Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
This document specifies requirements for disposable extracorporeal blood and fluid circuits and accessories used in combination with haemodialysis equipment intended for extracorporeal blood...
July 1, 2018
Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this document.
This document specifies requirements for the blood circuit for...