Newly approved EN ISO 23500 series ‘Preparation and quality management of fluids for haemodialysis and related therapies' deals with water treatment and the production of dialysis fluid. The standard series is currently composed of four parts, respectively dedicated to general requirements (EN ISO 23500-1), water treatment equipment for haemodialysis application (EN ISO 23500-2), water (EN ISO 23500-3) and concentrates for haemodialysis (EN ISO 23500-4).
Indeed, it has long been known that chemical and microbiological contamination of dialysis fluid places haemodialysis patients at risk of acute and chronic problems. One of the main challenges was including fluid quality requirements in a document directed at manufacturers of water treatment equipment or haemodialysis machines. This is where the EN ISO 23500 series comes in: its objective is to provide users with guidance for handling water and concentrates and for the production and quality oversight of dialysis fluid used for haemodialysis. The need for such guidance is based on the critical role played by the quality of the dialysis fluid in providing safe and effective haemodialysis, and the recognition that day-to-day dialysis fluid quality is under the control of the healthcare professionals who deliver therapy.
The series targets healthcare professionals who are involved in the management or routine care of haemodialysis patients and responsible for the quality of dialysis fluid. It takes into account that the equipment used in the various stages of dialysis fluid preparation is generally sold by specialised vendors, and dialysis practitioners are normally responsible for maintaining the equipment following its installation. Therefore, EN ISO 23500 provides guidance on quality oversight and maintenance of the equipment to ensure that dialysis fluid quality is acceptable at all times. The user is advised to follow the manufacturer's instructions regarding the operation and maintenance of equipment. In those instances in which the equipment is not acquired from a specialised vendor, it is the user’s responsibility to validate its performance and to ensure that appropriate operating and maintenance manuals are available.
The newly approved standards reflect the conscientious efforts of healthcare professionals, patients, and medical device manufacturers to improve the handling of water and concentrates and the production and surveillance of dialysis fluid for haemodialysis, in order to protect haemodialysis patients from adverse effects arising from known chemical and microbial contaminants.
The EN ISO 23500 series was adopted at the European level by CEN/TC 205 ‘Non-active medical devices’, whose Secretariat is held by DIN, Germany’s National Standardization Body.
For more information,please contact Jennifer Ogbonna