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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Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Quality of dialysis fluid for haemodialysis and related therapies (ISO 11663:2014)

Superseded date

03-25-2022

Published date

11-04-2015

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

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.

Committee
CEN/TC 205
DocumentType
Standard
PublisherName
Comite Europeen de Normalisation
Status
Superseded
SupersededBy

DIN EN ISO 13958:2016-03 CONCENTRATES FOR HAEMODIALYSIS AND RELATED THERAPIES (ISO 13958:2014)
DIN EN ISO 13958 E : 2016 CONCENTRATES FOR HAEMODIALYSIS AND RELATED THERAPIES (ISO 13958:2014)

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

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