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BS EN ISO 23500:2015

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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Guidance for the preparation and quality management of fluids for haemodialysis and related therapies

Available format(s)

Hardcopy , PDF

Superseded date

27-03-2019

Superseded by

BS EN ISO 23500-1:2019

Language(s)

English

Published date

31-10-2015

€348.24
Excluding VAT

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

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.

Committee
CH/150/2
DevelopmentNote
Renumbers and supersedes BS ISO 23500. 2015 version incorporates corrigendum to BS ISO 23500. Supersedes 10/30201925 DC & 13/30270474 DC. (10/2015)
DocumentType
Standard
Pages
96
PublisherName
British Standards Institution
Status
Superseded
SupersededBy
Supersedes

ISO 23500:2014 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, ISO 23500:2014 functions as a recommended practice. ISO 23500:2014 addresses the user\'s responsibility for the dialysis fluid once the equipment used in its preparation has been delivered and installed. For the purposes of ISO 23500:2014, the dialysis fluid includes dialysis water used for the preparation of dialysis fluid and substitution fluid, dialysis water used for the preparation of concentrates at the user\'s facility, as well as concentrates and the final dialysis fluid and substitution fluid.

Standards Relationship
EN ISO 23500:2015 Identical
ISO 23500:2014 Identical

ISO 11663:2014 Quality of dialysis fluid for haemodialysis and related therapies
IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
ISO 13958:2014 Concentrates for haemodialysis and related therapies
ISO 26722:2014 Water treatment equipment for haemodialysis applications and related therapies
IEC 60529:1989+AMD1:1999+AMD2:2013 CSV Degrees of protection provided by enclosures (IP Code)
ISO 13959:2014 Water for haemodialysis and related therapies

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