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*(1) General
(a) In new construction and renovation in any hospital where hemodialysis or hemoperfusion is routinely performed, the following shall be provided:
(i) Separate treated water distribution system
(ii) Drainage system independent from the tap water
(b) If the dialysis equipment used includes sufficient water treatment provisions, use of domestic cold water without special piping (rather than a separate treated water system) shall be permitted.
(2) Treated water distribution system. Where provided, a separate treated water distribution system shall meet the following requirements:
(a) The treated water system shall be in accordance with ANSI/AAMI/ISO 26722: Water Treatment Equipment for Hemodialysis Applications and Related Therapies.
(b) Treated water distribution outlets shall be provided for these areas:
(i) Each individual hemodialysis treatment bay
(ii) Hemodialysis equipment repair area
(iii) Dialysate preparation area
(c) Treated water systems for hemodialysis and related therapies shall meet the current requirements of ANSI/AAMI/ISO 13959: Water for Hemodialysis and Related Therapies.
(3) Dialysis equipment or water system components shall meet FDA 510 (k) approval and the requirements of class 2 medical device(s).
(4) The liquid waste and disposal system for the hemodialysis treatment area shall be designed to minimize odor and prevent backflow.
(5) All hemodialysis distribution piping shall be readily accessible for inspection and maintenance.
A2.1- (1) Separate treated water distribution system. Use of portable water treatment equipment or integrated hemodialysis machines (with water treatment as part of the machine) does not require a separate treated water distribution system. However, the water purification requirements (i.e., chemical and microbial quality of product water) are the same, whether portable units or a separate treated water system supplying multiple dialysis stations/machines is used.

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