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EVS-EN 13867:2002+A1:2009

Concentrates for haemodialysis and related therapies CONSOLIDATED TEXT

General information

Withdrawn from 05.01.2016
Base Documents
EN 13867:2002+A1:2009
ICS Groups
11.040.20 Transfusion, infusion and injection equipment 11.120.99 Other standards related to pharmaceutics
Directives or regulations
93/42/EEC Medical devices (MDD)

Although the standard’s status is withdrawn, it still has the presumption of conformity in the meaning of regulation 93/42/EEC and conformance with the regulation ’s requirements can be guaranteed by using the withdrawn version of the standard. The presumption of conformity is valid until a corresponding amendment is published in the Official Journal of the European Union.
 
To view the latest lists of harmonised standards published in the Official Journal of the European Union, visit: http://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/

Standard history

Status
Date
Type
Name
05.01.2016
Main
EVS-EN ISO 13958:2015
03.12.2009
Main + amendment
EVS-EN 13867:2002+A1:2009
Main
EVS-EN 13867:2002
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.

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Standard monitoring
English (PDF 233 KB)

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Standards designation

EVS Estonian standard
EN European standard (published by an CEN or CENELEC)
EN ISO International standard adopted as an European standard
ISO International Organization for Standardization’s standard
IEC International Electrotechnical Commission’s standard
HD CENELEC’s harmonisation document
   
EVS-EN European standard implemented in Estonia
EVS-EN ISO International standard adopted in Europe and implemented in Estonia
EVS-EN ISO/IEC International standard/International electrotechnical standard adopted in Europe and implemented in Estonia
EVS-IEC International electrotechnical standard implemented in Estonia
EVS-ISO International standard implemented in Estonia
   
A, AMD amedment
+A a full standard plus the amendment
/A only amendment
COR, AC corrigendum
+COR a full standard plus the corrigendum
NA national annex
+NA a full standard plus the national annex
/NA only national annex
TS technical specification
TR technical report
CWA agreement, developed by a CEN or CENELEC
prEVS-EN (etc) draft standard
   
et the standard is in Estonian only
en the standard is in English only
et-en the standard is in Parallel text Estonian-English