Applies to a) acute, chronic, and home-based hemodialysis; b) water for preparing dialyzing fluid and concentrate for hemodialysis; c) all water intended for contact with the dialyzing fluid pathway; d) the baseline quality of the feed water and any other input water; e) water treatment and monitoring equipment; f) water distribution systems; and g) product water used for flushing blood pathways before sterilization (but not afterwards).