BS EN ISO 13959:2015
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Water for haemodialysis and related therapies
Hardcopy , PDF
27-03-2019
English
31-01-2016
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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.
| 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Superseded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 |
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.
| 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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