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EN 13867:2002+A1:2009 Standard

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  Keywords:

#concentrates #european #standard #microbiological #chemical

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Wednesday 14th of April 2021

  Description:

Concentrates for haemodialysis and related therapies

  Purpose

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.

  Publication

Wednesday 25th of March 2020

  Amendment

This standard is an amendment for "EN 13867:2002"

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