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SRPS EN 13867:2011

Concentrates for haemodialysis and related therapies

Aug 29, 2011
95.99 Withdrawal of Standard   Jan 31, 2017

General information

95.99     Jan 31, 2017

ISS

Z076

European Norm

11.040.20     11.120.99  

English  

From plan 2011

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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 directives

Directives related to this standard.

93/42/EEC

Medical devices

Harmonized
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WITHDRAWN
SRPS EN 13867:2011
95.99 Withdrawal of Standard
Jan 31, 2017

REVISED BY

WITHDRAWN
SRPS EN ISO 13958:2017

Related project

Adopted from EN 13867:2002+A1:2009