UNI EN 13867 : 2009
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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
21-01-2016
01-01-2009
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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