What is ISO 23500-1- Fluids for haemodialysis about?
ISO 23500-1 is the first part of the multi-series standard on preparation and quality management of fluids for haemodialysis and related therapies which outlines general requirements for hemodialysis.
ISO 23500-1 is the base standard for several other standards dealing with water treatment equipment, water, dialysis water, concentrates, and dialysis fluid (ISO 23500 series) and provides dialysis practitioners with guidance on the preparation of dialysis fluid for haemodialysis and related therapies and substitution fluid for use in online therapies, such as haemodiafiltration and haemofiltration. As such, this document functions as a recommended practice.
Who is ISO 23500-1- Fluids for haemodialysis for?
ISO 23500-1 is useful for-
- Manufacturers of fluids for haemodialysis
- Medical laboratories
- Hospitals
Why should you use ISO 23500-1-Fluids for haemodialysis?
ISO 23500-1 provides you 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 of dialysis fluid quality 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 dialysis therapy.
ISO 23500-1 reflects the conscientious efforts of healthcare professionals, patients, and medical device manufacturers to develop recommendations for handling water and concentrates and for the production and surveillance of dialysis fluid for haemodialysis and protecting haemodialysis patients from adverse effects arising from known chemical and microbial contaminants that might be found in the improperly prepared dialysis fluid
What’s changed since the last update?
BS EN ISO 23500-1:2019 supersedes ISO 23500-1:2014, which has been withdrawn. BS EN ISO 23500-1:2019 Has some technical changes with respect to ISO 23500-1:2014, these include:
- The document forms part of a revised and renumbered series dealing with the preparation and quality management of fluids for haemodialysis and related therapies. The series comprises ISO 23500-1 (previously ISO 23500), ISO 235002, (previously ISO 26722), ISO 235003, (previously ISO 13959), ISO 235004, (previously ISO 13958), and ISO 235005, (previously ISO 11663).