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haemodialysis_quality_standards - Rotary International District 3310

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CHAPTER 4: DIALYSIS CONSUMABLES<br />

4.1 Dialysis Concentrate<br />

4.1.1 Commercially prepared dialysate<br />

Commercially prepared or ready-made dialysate shall be accompanied<br />

<br />

<br />

4.1.2 On-site dialysate preparation<br />

<br />

Due to lack of technical support and expertise, on-site dialysate<br />

preparation is currently not recommended.<br />

<br />

However, centres that currently prepare on-site dialysate shall<br />

comply with the 1SO 23500:2011 Standards and establish a<br />

Standard Operating Procedure (SOP) on dialysate preparation<br />

and dispensing.<br />

4.1.3 The dialysate packaging shall have the following information clearly<br />

labelled:<br />

<br />

<br />

<br />

<br />

Address of manufacturer<br />

Contents<br />

Concentration of electrolytes<br />

Dialysate concentration ratio<br />

<br />

Date of manufacture and expiry<br />

4.2 Dialysers<br />

4.2.1 Dialysers used for <strong>haemodialysis</strong> treatment shall be approved by<br />

regulatory authorities in USA, Europe, Japan or local equivalent.<br />

4.2.2 Dialysers made from biocompatible membrane shall be used.<br />

Haemodialysis Quality and Standards 23

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