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BS EN ISO 13959:2015

BS EN ISO 13959:2015

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Water for haemodialysis and related therapies

Available format(s)

Hardcopy , PDF

Superseded date

03-27-2019

Language(s)

English

Published date

01-31-2016

Publisher

British Standards Institution

European foreword
Foreword
Introduction
1 Scope
2 Terms and definitions
3 Dialysis water requirements
4 Tests for compliance with microbiological
  and chemical requirements
Annex A (informative) - Rationale for the
        development and provisions of this
        International Standard
Bibliography
Annex ZA (informative) - Relationship between
         this European Standard and the Essential
         Requirements of EU Directive
         93/42/EEC on medical devices

Defines minimum requirements for water to be used in haemodialysis and related therapies.

This International Standard specifies minimum requirements for water to be used in haemodialysis and related therapies.

This International Standard includes water to be used in the preparation of concentrates, dialysis fluids for haemodialysis, haemodiafiltration and haemofiltration, and for the reprocessing of haemodialysers.

The operation of water treatment equipment and the final mixing of treated water with concentrates to produce dialysis fluid are excluded from this International Standard. Those operations are the sole responsibility of dialysis professionals. This International Standard does not apply to dialysis fluid regenerating systems.

Committee
CH/150/2
DevelopmentNote
Renumbers and supersedes BS ISO 13959. 2015 version incorporates corrigendum to BS ISO 13959. Supersedes 13/30270471 DC. (02/2016)
DocumentType
Standard
Pages
28
PublisherName
British Standards Institution
Status
Superseded
SupersededBy
Supersedes

Standards Relationship
ISO 13959:2014 Identical
EN ISO 13959:2015 Identical

AAMI RD5 : 2003 HEMODIALYSIS SYSTEMS
ISO 13958:2014 Concentrates for haemodialysis and related therapies
ISO 23500:2014 Guidance for the preparation and quality management of fluids for haemodialysis and related therapies

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Hardcopy - English
PDF - English
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