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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Quality of dialysis fluid for haemodialysis and related therapies (ISO 11663:2014)
04-11-2015
25-03-2022
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Superseded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 |
| Standards | Relationship |
| ISO 11663:2014 | Identical |
| NF EN ISO 11663 : 2015 | Identical |
| BS EN ISO 11663:2015 | Identical |
| NS EN ISO 11663 : 2015 | Identical |
| I.S. EN ISO 11663:2015 | Identical |
| NEN EN ISO 11663 : 2015 | Identical |
| DIN EN ISO 11663:2016-02 | Identical |
| PN EN ISO 11663 : 2016 | Identical |
| UNE-EN ISO 11663:2016 | Identical |
| DIN EN ISO 13958:2016-03 | 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 |