SN EN 13867 : 2002 + A1 2009
Current
The latest, up-to-date edition.
CONCENTRATES FOR HAEMODIALYSIS AND RELATED THERAPIES
12-01-2013
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
4.1 Concentration limits
4.2 Water quality
4.3 pH range
4.4 Chemical quality
4.5 Manufacturing process (filtration)
4.6 Containers
4.7 Microbiological quality
5 Labelling and documentation requirements
5.1 General
5.2 Information to be given on the concrete container
5.3 Information to be given on the shipping container,
if any
5.4 Information to be given in the accompanying documents
5.5 Colour coding
6 Test methods
6.1 Water quality
6.2 pH
6.3 Manufacturing process (filtration)
6.4 Containers
6.5 Microbiological quality
6.6 Sterility
Annex A (informative) Examples of analytical methods
Annex ZA (informative) Clauses of this European Standard
addressing Essential Requirements or other
provisions of EU Directives
Annex ZB (informative) A-deviations
Bibliography
Describes requirements for dry and liquid concentrates to be diluted for use as dialysing fluids in haemodialysis or related therapies. Addresses chemical and microbiological quality and purity, handling and labeling of concentrates.
| DevelopmentNote |
2002 Edition Re-issued in November 2009 & incorporates AMD 1 2009. (12/2009)
|
| DocumentType |
Standard
|
| PublisherName |
Swiss Standards
|
| Status |
Current
|
| Standards | Relationship |
| EN 13867:2002+A1:2009 | Identical |
| UNE-EN 13867:2003 | Identical |
| BS EN 13867 : 2002 | Identical |
| DIN EN 13867:2003-01 | Identical |
| UNI EN 13867 : 2009 | Identical |
| DIN EN 13867:2009-09 | Identical |
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