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BS EN ISO 23500-5:2019

$102.76

Preparation and quality management of fluids for haemodialysis and related therapies – Quality of dialysis fluid for haemodialysis and related therapies

Published By Publication Date Number of Pages
BSI 2019 24
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This document specifies minimum quality requirements for dialysis fluids used in haemodialysis and related therapies.

This document includes dialysis fluids used for haemodialysis and haemodiafiltration, including substitution fluid for haemodiafiltration and haemofiltration.

This document excludes the water and concentrates used to prepare dialysis fluid or the equipment used in its preparation. Those areas are covered by other International Standards.

Sorbent-based dialysis fluid regeneration systems that regenerate and recirculate small volumes of dialysis fluid, systems for continuous renal replacement therapy that use pre-packaged solutions, and systems and solutions for peritoneal dialysis are excluded from this document.

PDF Catalog

PDF Pages PDF Title
2 National foreword
4 European foreword
6 Foreword
7 Introduction
9 1 Scope
2 Normative references
3 Terms and definitions
10 4 Requirements
4.1 Microbiological contaminants in dialysis fluid
4.1.1 General
4.1.2 Microbiological requirements for standard dialysis fluid
4.1.3 Microbiological requirements for ultrapure dialysis fluid
4.1.4 Microbiological requirements for online prepared substitution fluid
11 4.2 Chemical contaminants in dialysis fluid
5 Tests for conformity with microbiological requirements
5.1 Sampling
5.2 Culture methods
13 Annex A (informative) Rationale for the development and provisions of this document
16 Annex B (informative) Reference tables
19 Bibliography
BS EN ISO 23500-5:2019
$102.76