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BS EN ISO 11663:2015

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by

Quality of dialysis fluid for haemodialysis and related therapies

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

30-11-2015

Superseded date

27-03-2019

Superseded by

BS EN ISO 23500-5:2019

£232.00
Excluding VAT

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Tests for compliance with microbiological
  requirements
Annex A (informative) - Rationale for the
        development and provisions of this
        International Standard
Annex B (informative) - Reference tables from
        ISO 13959
Bibliography
Annex ZA (informative) - Relationship between this European
         Standard and the Essential Requirements of EU
         Directive 93/42/EEC on medical devices

Gives minimum quality requirements for dialysis fluids used in haemodialysis and related therapies.

Committee
CH/150/2
DevelopmentNote
Renumbers and supersedes BS ISO 11663. 2015 version incorporates corrigendum to BS ISO 11663. Supersedes 13/30270465 DC. (12/2015)
DocumentType
Standard
Pages
30
PublisherName
British Standards Institution
Status
Superseded
SupersededBy
Supersedes

ISO 11663:2014 specifies minimum quality requirements for dialysis fluids used in haemodialysis and related therapies. ISO 11663:2014 includes dialysis fluids used for haemodialysis and haemodiafiltration, including substitution fluid for haemodiafiltration and haemofiltration.

Standards Relationship
ISO 11663:2014 Identical
EN ISO 11663:2015 Identical
I.S. EN ISO 11663:2015 Equivalent

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
ISO 13959:2014 Water for haemodialysis and related therapies
AAMI RD52 : 2004 DIALYSATE FOR HEMODIALYSIS

£232.00
Excluding VAT