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BS EN ISO 23500 : 2015

M00016951

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BS EN ISO 23500 : 2015

GUIDANCE FOR THE PREPARATION AND QUALITY MANAGEMENT OF FLUIDS FOR HAEMODIALYSIS AND RELATED THERAPIES

British Standards Institution

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Table of Contents

Foreword<br>Introduction<br>1 Scope<br>2 Normative references<br>3 Terms and definitions<br>4 Summary of quality requirements of ISO 13958,<br>&nbsp;&nbsp;&nbsp;ISO 13959 and ISO 11663<br>5 Critical aspects of system design<br>6 Validation of system performance<br>7 Quality management<br>8 Strategies for microbiological control<br>9 Environment<br>10 Personnel<br>Annex A (informative) - Rationale for the<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;development and provisions of this<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;International Standard<br>Annex B (informative) - Equipment<br>Annex C (informative) - Monitoring guidelines<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;for water treatment equipment,<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;distribution systems, and dialysis fluid<br>Annex D (informative) - Strategies for microbiological<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;control<br>Annex E (informative) - Validation<br>Annex F (informative) - Special considerations for<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;home haemodialysis<br>Annex G (informative) - Special considerations for<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;acute haemodialysis<br>Bibliography

Abstract

Gives 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.

General Product Information

Document Type Standard
Status Current
Publisher British Standards Institution
Committee CH/150/2
Supersedes
  • BS ISO 23500 : 2014
  • 13/30270474 DC : 0
  • 10/30201925 DC : 0