EN 13867:2002+A1:2009

Name: EN 13867:2002+A1:2009
Brand: CEN

Superseded

View Superseded by

Concentrates for haemodialysis and related therapies

Superseded date

12-01-2015

Published date

06-17-2009

Publisher

Comite Europeen de Normalisation

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Labelling and documentation requirements
6 Test methods
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

This European Standard specifies requirements for dry and liquid concentrates to be diluted for use as dialysing fluids in haemodialysis or related therapies. It addresses 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.This European standard does not address the final mixing and use of these concentrates or the treated water used in connection with haemodialysis and related therapies. This European standard does not apply to dialysing fluid regeneration systems.

Committee	CEN/TC 205
DevelopmentNote	2002 Edition Re-Issued in June 2009 & incorporates AMD 1 2009. (08/2009)
DocumentType	Standard
PublisherName	Comite Europeen de Normalisation
Status	Superseded
SupersededBy	EN ISO 13958:2015

Standards	Relationship
NBN EN 13867 : 2002 + A1 2009	Identical
PN EN 13867 : 2003 + A1 2009	Identical
NS EN 13867 : 2002 + A1 2009	Identical
BS EN 13867 : 2002	Identical
UNI EN 13867 : 2009	Identical
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
UNE-EN 13867:2003+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
IEC 60601-2-16 : 4.0	MEDICAL ELECTRICAL EQUIPMENT - PART 2-16: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HAEMODIALYSIS, HAEMODIAFILTRATION AND HAEMOFILTRATION EQUIPMENT
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