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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
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
Describes requirements for dry and liquid concentrates to be diluted for use as dialysing fluids in haemodialysis or related therapies. Also applies to chemical and microbiological quality and purity, handling and labelling of concentrates, the requirements for containers and the tests to monitor chemical and microbiological contents and quality of such concentrates.
| DocumentType |
Standard
|
| PublisherName |
Ente Nazionale Italiano di Unificazione (UNI)
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| SN EN 13867 : 2002 + A1 2009 | Identical |
| NEN EN 13867 : 2002 + A1 2009 | Identical |
| I.S. EN 13867:2002 | Identical |
| UNE-EN 13867:2003 | Identical |
| DIN EN 13867:2009-09 | Identical |
| NF EN 13867 : 2003 + A1 2009 | Identical |
| BS EN 13867 : 2002 | Identical |
| NBN EN 13867 : 2002 + A1 2009 | Identical |
| NS EN 13867 : 2002 + A1 2009 | Identical |
| EN 13867:2002+A1:2009 | Identical |
| DIN EN 13867:2003-01 | Identical |
| EN 556:1994 + A1:1998 | STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR TERMINALLY-STERILIZED MEDICAL DEVICES TO BE LABELLED "STERILE" |
| EN 1174-3 : 1996 | STERILIZATION OF MEDICAL DEVICES - ESTIMATION OF THE POPULATION OF MICRO-ORGANISMS ON PRODUCT - GUIDE TO THE METHODS FOR VALIDATION OF MICROBIOLOGICAL TECHNIQUES |
| EN 1174-1 : 1996 | STERILIZATION OF MEDICAL DEVICES - ESTIMATION OF THE POPULATION OF MICRO-ORGANISMS ON PRODUCT - REQUIREMENTS |
| EN 1174-2 : 1996 | STERILIZATION OF MEDICAL DEVICES - ESTIMATION OF THE POPULATION OF MICRO-ORGANISMS ON PRODUCT - GUIDANCE |
| EN 980:2008 | Symbols for use in the labelling of medical devices |
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