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This Malaysian Standard is addressed to the manufacturer and/or supplier of water treatment systems and/or devices used for the express purpose of providing water for haemodialysis or related therapies.
This standard covers devices used to treat water intended for use in the delivery of haemodialysis and related therapies. Included in the scope of this standard is water used for:
a) the preparation of concentrates from powder or other highly concentrated media at a dialysis facility;
b) the preparation of dialysis fluid that may be used for the preparation of substitution fluid;
c) the reprocessing of dialysers for multiple uses.
Included within the scope of this standard are all devices, piping and fittings between the point at which potable water is delivered to the water treatment system and the point of use of the dialysis water. Examples of devices included within the scope of this standard are water purification devices, online water quality monitors (such as conductivity monitors), and piping systems for the distribution of dialysis water.
Excluded from the scope of this standard are dialysis fluid supply systems that proportion water and concentrates to produce dialysis fluid, sorbent dialysis fluid regeneration systems that regenerate and recirculate small volumes of the dialysis fluid, dialysis concentrates, haemodiafiltration systems, haemofiltration systems, systems that process dialysers for multiple uses, and peritoneal dialysis systems. Some of these devices, such as dialysis fluid delivery systems and concentrates, are addressed in other standards. Also excluded from the scope of this standard are requirements for the ongoing monitoring of the purity of water used for dialysis fluid, concentrate preparation or dialyser reprocessing.
Primary Item Type:
Malaysian Standard
Identifiers:
Standard Number MS ISO 26722:2010
ISC ISC R - Medical Devices and Facilities for Healthcare
ICS 11.040.40
Language:
English
Subject Keywords:
Water treatment; Haemodialysis; Related therapies; Requirements
MS ISO 26722:2010 WATER TREATMENT EQUIPMENT FOR HAEMODIALYSIS APPLICATIONS AND RELATED THERAPIES (ISO 26722:2009, IDT)