NEN 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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
CONCENTRATES FOR HAEMODIALYSIS AND RELATED THERAPIES
16-12-2015
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
Defines requirements for dry and liquid concentrates to be diluted for use as dialysing fluids in haemodialysis or related therapies.
| DevelopmentNote |
2002 Edition Re-Issued in July 2009 & incorporates AMD 1 2009. (07/2009)
|
| DocumentType |
Standard
|
| PublisherName |
Netherlands Standards
|
| Status |
Superseded
|
| 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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