I.S. EN ISO 11663:2015
Withdrawn
View Superseded by
QUALITY OF DIALYSIS FLUID FOR HAEMODIALYSIS AND RELATED THERAPIES (ISO 11663:2014)
Hardcopy , PDF
English
11-22-2015
09-30-2019
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.
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Withdrawn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 |
| BS 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 |
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