60.60 Standard published Apr 17, 2024
CEN
CEN/TC 205 Non-active medical devices
European Norm
11.040.20 Transfusion, infusion and injection equipment
Draft
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.
WITHDRAWN
EN ISO 8637-2:2018
PUBLISHED
EN ISO 8637-2:2024
60.60
Standard published
Apr 17, 2024
