CSA ISO 8638
Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
|Publication Date:||1 January 2012|
|ICS Code (Implants for surgery, prosthetics and orthotics):||11.040.40|
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;
⎯ 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.