ISO23500-22024＆ISO23500-32024(部分）

IS023500-2:2024[emensuring that incorporation of the device does not compromise the ability of the overall system to deliverdialysis water capable of meeting the requirements of 4.1.2 and 4.1.4.The water treatment and distribution system should include appropriate pressure gauges,flow meters,sample ports and other ancillary equipment necessary to allow surveillance of the performance of individualsystem devices and the system as a whole.Valves can be included in the water treatment system to allow individual devices to be bypassed whenthere is device failure or to facilitate replacement of a device.Bypass valves should have a physical lockoutinstalled and be labelled with a warning notifying the user of the result of its removal.If it is possible to bypass a device of the water treatment system,then the manufacturer or installer of thatcomponent shall inform the user of the risks associated with bypassing that device and the need for clearlydefining the responsibility for operating the bypass.Where such valves are installed,however,a meansshould be included to minimize the likelihood that the device will be inadvertently bypassed during normaloperation of the system.Bypass valves should not be used to bypass deionization tanks,carbons and other critical components e.g.reverse osmosis (RO)systems.They should not be used on ultrafilters used in conjunction with deionizationtanks for patient treatment.Operating controls shall be positioned so as to minimize inadvertent resetting.Electrical circuits shall be separate from hydraulic circuits and adequately protected from fluid leaks.4.2.1.2 Materials compatibilityMaterials thatare in contact with dialysis water (including materials used in piping,storage and distributionsystems)shall not interact chemically or physically with that water so as to adversely affect its purityor quality.Water-contacting surfaces shall be fabricated from non-reactive materials (e.g.plastics)orappropriate stainless steel.The use of materials known to cause toxicity in haemodialysis,such as copper,brass,galvanized metal or aluminium,are specifically prohibited at any point beyond the water treatmentdevice used to remove contaminating metal ions,most commonly a reverse osmosis system or a deionizer.The materials of any water treatment devices (including piping,storage,and distribution systems)shall becompatible with the means used to disinfect those devices.Chemicals infused into the water in the pre-treatment section,such as chlorine,acid,flocculants and complexing agents,shall be adequately removedfrom dialysis water before they reach any point of use.Monitors or specific test procedures to verify removalofadditives shall be provided.4.2.1.3 Regenerated or reconstituted devicesAll devices that are regenerated or reconstituted at a site remote from the dialysis facility,such asdeionizers,shall be disinfected at the time of regeneration or reconstitution so that contaminated water isnot reintroduced into the system after rege