This is the first edition of CAN/CSA-ISO 8638, Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters, which is an adoption, without modification, of the identically titled ISO (International Organization for Standardization) Standard 8638 (third edition, 2010-07-01). It replaces the previous edition published in 2008 as CAN/CSA-Z8638, Cardiovascular implants and artificial organs - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (adopted ISO 8638:2004).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;
- 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.
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CAN/CSA-Z8638-08 - Cardiovascular Implants and Artificial Organs - Extracorporeal Blood Circuit for Haemodialysers, Haemodiafilters and Haemofilters (Adopted ISO 8638:2004, second edition, 2004-10-01, with Canadian deviations)