CSA Standards

Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters - First Edition
 N CAN/CSA-ISO 8638:12

Annotation

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.

Автоматический перевод:

Сердечно-сосудистые имплантаты и происходящие вне организма системы - Происходящая вне организма схема крови для haemodialysers, haemodiafilters и haemofilters - Первый Выпуск