1

Scope

Z364.1.1 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, valid ation 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.

Canadian Deviations and Editorial Changes are included in this Standard. /

Z364.1.2 This International Standard specifies requirements for the extracorporeal blood circuit for single use which is to be used in conjunction with haemodialysers, haemofilters and haemoconcentrators.

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 applies to the blood tubing and integral accessory tubing, including fluid and infusion tubings and tubing for attaching the extracorporeal blood circuit to pressure monitors.

This International Standard does not apply to haemodialysers, haemofilters, haemoconcentrators, vascular access devices, blood pumps, pressure monitors of the extracorporeal blood cicuit, air detection devices, haemodialysis systems to prepare, maintain and monitor the dialysing fluid, and hardware used to perform haemofiltration or haemoconcentration.

Notes: (1) For requirements applicable to the haemodialyser, haemofilter, and haemoconcentrator, users should consult CSA Standard Z364.1.1. (2) For requirements addressing the fluid supply and monitoring systems, users are invited to consult CSA Standard Z364.2.1. (3) Electrical safety requirements are contained within either CSA Standard C22.2 No. 125 or CAN/CSA-C22.2 No. 601.1, and CAN/CSA-C22. 2 No. 601.2.16. (4) Requirements for water treatment and water quality are contained within CSA Standard Z364.2.2.

Canadian Deviations and Editorial Changes are included in this Standard.