CAN/CSA-Z364.1.1-94 (R2006)

This National Standard of Canada is based on International Standard ISO 8637:1989. 1 Scope This International Standard specifies requirements for haemodialysers, including those of coil, hollow fibre and parallel plate design, haemofilters and haemoconcentrators for single use for humans. Materials of construction and test methods for biocompatibility, validation of sterility, non-pyrogenicity and some performance characteristics are not specified; the rationale for these omissions is given in the Introduction. This International Standard does not apply to devices assembled and sterilized by the user, the extracorporeal blood circuit, plasma filters, haemoperfusion devices, vascular access devices, blood pumps, pressure monitors of the extracorporeal circuit, air detection devices or systems to prepare, maintain or monitor dialysing fluid. Notes: (1) For requirements applicable to the extracorporeal circuit, users should consult CSA Standards Z364.1.2 and Z364.2.1. (2) For requirements applicable to electrical safety, users should consult CSA Standards C22.2 No.125 or CAN/CSA-C22.2 No.601.1, and CAN/CSA-C22.2 No.601.2.16. (3) Requirements for water treatment and water quality are contained within CSA Standard Z364.2.2.