EN 13867:2002+A1:2009

Concentrates for haemodialysis and related therapies

Publication date:   Sep 16, 2010

General information

99.60 Withdrawal effective   Dec 2, 2015

CEN

CEN/TC 205 Non-active medical devices

European Norm

11.040.20   Transfusion, infusion and injection equipment | 11.120.99   Other standards related to pharmaceutics

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Scope

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.

Related legislation

Legislation related to this standard

93/42/EEC

Medical devices

Harmonized/Supporting
2007/47/EC

Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market

Life cycle

NOW

WITHDRAWN
EN 13867:2002+A1:2009
99.60 Withdrawal effective
Dec 2, 2015

REVISED BY

WITHDRAWN
EN ISO 13958:2015