BS EN ISO 8637-2:2024 - TC

This standard BS EN ISO 8637-2:2024 - TC Tracked Changes. Extracorporeal systems for blood purification is classified in these ICS categories:

• 11.040.20 Transfusion, infusion and injection equipment
• 11.040.40 Implants for surgery, prosthetics and orthotics

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.