I.S. EN 13867:2002
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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
Hardcopy , PDF
20-12-2015
English
01-01-2002
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.
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 concentrate 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) - Relationship between this European
Standard and the Essential Requirements
of EU Directive 93/42/EEC 'Medical
Devices'
Annex ZB (informative) - A-deviations
Bibliography
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