I.S. EN ISO 11663:2015
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
View Superseded by
QUALITY OF DIALYSIS FLUID FOR HAEMODIALYSIS AND RELATED THERAPIES (ISO 11663:2014)
Hardcopy , PDF
30-09-2019
English
22-11-2015
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
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National Foreword
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.
| DocumentType |
Standard
|
| Pages |
36
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Withdrawn
|
| SupersededBy |
| 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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