This is the first edition of CAN/CSA-ISO 8637, Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators, which is an adoption, without modification, of the identically titled ISO (International Organization for Standardization) Standard 8637 (third edition, 2010-07-01).
It replaces the previous edition published in 2008 as CAN/CSA-Z8637, Cardiovascular implants and artificial organs - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (adopted ISO 8637:2004).
This International Standard specifies requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators, hereinafter collectively referred to as the device, for use in humans.
This International Standard is not applicable to:
- extracorporeal blood circuits;
- 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 used to perform haemodialysis, haemodiafiltration, haemofiltration or haemoconcentration;
- reprocessing procedures and equipment.
NOTE Requirements for the extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters are specified in ISO 8638.
Amendment 1:2015 to CAN/CSA-ISO 8637:12, Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators - Amendment 1: Revision to figure 2 - Main fitting dimensions of dialysis fluid inlet and outlet ports (Adopted amendment 1:2013 to ISO 8637:2010)