BS EN ISO 8638:2014

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.

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