scope:

General

This Standard specifies requirements for the safe use, disinfection, testing, and maintenance of monitoring systems for hemodialysis. It is intended for use by dialysis providers, including health care workers and professionals who perform technical and operational functions associated with hemodialysis. This Standard applies to

a) quality management;

b) monitoring of fluid quality systems;

c) maintenance requirements;

d) biocompatibility of material components;

e) disinfection of the hydraulic fluid path and blood tubing transducer protectors;

f) dialysing fluid and blood circuit systems; and

g) equipment testing electrical safety.

Exclusions

This Standard does not include requirements for

a) systems that regenerate the dialysing fluid;

b) dialysers;

c) blood tubings;

d) blood access devices;

e) hemoperfusion devices;

f) hemofiltration systems that do not produce on-line fluid; and

g) the frequency of monitoring of the purity of water used for dialysing fluid.

Notes:

1) For requirements for hemodialysers, hemodiafilters, hemofilters, hemoconcentrators, and the associated extracorporeal circuits, users should consult CAN/CSA-ISO 8637 and CAN/CSA-ISO 8638.

2) For requirements for monitoring water quality, users should consult CAN/CSA-ISO 11663, CAN/CSA-ISO 13959, and CAN/CSA-ISO 26722.