EN 13867:2002+A1:2009
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Concentrates for haemodialysis and related therapies
01-12-2015
17-06-2009
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Labelling and documentation requirements
6 Test methods
Annex A (informative) - Examples of analytical methods
Annex ZA (informative) - Relationship between this European
Standard and the Essential Requirements of EU
Directive 93/42/EEC 'Medical Devices'
Annex ZB (informative) - A-deviations
Bibliography
This European Standard specifies requirements for dry and liquid concentrates to be diluted for use as dialysing fluids in haemodialysis or related therapies. It addresses chemical and microbiological quality and purity, handling and labelling of concentrates, the requirements for containers and the tests to monitor chemical and microbiological contents and quality of such concentrates.This European standard does not address the final mixing and use of these concentrates or the treated water used in connection with haemodialysis and related therapies. This European standard does not apply to dialysing fluid regeneration systems.
| Committee |
CEN/TC 205
|
| DevelopmentNote |
2002 Edition Re-Issued in June 2009 & incorporates AMD 1 2009. (08/2009)
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| NBN EN 13867 : 2002 + A1 2009 | Identical |
| PN EN 13867 : 2003 + A1 2009 | Identical |
| NS EN 13867 : 2002 + A1 2009 | Identical |
| BS EN 13867 : 2002 | Identical |
| UNI EN 13867 : 2009 | Identical |
| SN EN 13867 : 2002 + A1 2009 | Identical |
| NEN EN 13867 : 2002 + A1 2009 | Identical |
| I.S. EN 13867:2002 | Identical |
| UNE-EN 13867:2003 | Identical |
| DIN EN 13867:2009-09 | Identical |
| NF EN 13867 : 2003 + A1 2009 | Identical |
| UNE-EN 13867:2003+A1:2009 | Identical |
| BS EN 13867:2002+A1:2009 | Identical |
| DIN EN 13867:2003-01 | Identical |
| EN 556:1994 + A1:1998 | STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR TERMINALLY-STERILIZED MEDICAL DEVICES TO BE LABELLED "STERILE" |
| EN 1174-3 : 1996 | STERILIZATION OF MEDICAL DEVICES - ESTIMATION OF THE POPULATION OF MICRO-ORGANISMS ON PRODUCT - GUIDE TO THE METHODS FOR VALIDATION OF MICROBIOLOGICAL TECHNIQUES |
| EN 1174-1 : 1996 | STERILIZATION OF MEDICAL DEVICES - ESTIMATION OF THE POPULATION OF MICRO-ORGANISMS ON PRODUCT - REQUIREMENTS |
| EN 1174-2 : 1996 | STERILIZATION OF MEDICAL DEVICES - ESTIMATION OF THE POPULATION OF MICRO-ORGANISMS ON PRODUCT - GUIDANCE |
| EN 980:2008 | Symbols for use in the labelling of medical devices |
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