CAN/CSA-ISO 8637:12 (R2017)
CSA Preface 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).
Scope 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; - 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 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.
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