BS EN ISO 11663:2015
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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Quality of dialysis fluid for haemodialysis and related therapies
Hardcopy , PDF
27-03-2019
English
30-11-2015
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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Superseded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 |
| 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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