SN EN 13867 : 2002 + A1 2009
Current
The latest, up-to-date edition.
CONCENTRATES FOR HAEMODIALYSIS AND RELATED THERAPIES
01-12-2013
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
Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.