BS EN ISO 8638:2014

Cardiovascular implants and extracorporeal systems. Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters. | Status: Superseded, Withdrawn

1 Scope This International Standard specifies requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (hereafter referred to as “the device”) and (integral and non-integral) transducer protectors which are intended for use in haemodialysis, haemodiafiltration and haemofiltration. This International Standard does not apply to:

• — haemodialysers, haemodiafilters or haemofilters;
• — plasmafilters;
• — haemoperfusion devices;
• — vascular access devices;
• — blood pumps;
• — pressure monitors for the extracorporeal blood circuit;
• — air detection devices;
• — systems to prepare, maintain or monitor dialysis fluid;
• — systems or equipment intended to perform haemodialysis, haemodiafiltration, haemofiltration or haemoconcentration.

NOTE Requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators are specified in ISO 8637.