EN ISO 13958:2015

Concentrates for haemodialysis and related therapies (ISO 13958:2014) EN ISO 13958:2015

Publication date:   Jan 18, 2016

General information

99.60 Withdrawal effective   Mar 20, 2019

CEN

CEN/TC 205 Non-active medical devices

European Norm

11.040.40   Implants for surgery, prosthetics and orthotics

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Scope

ISO 13958:2014 specifies minimum requirements for concentrates used for haemodialysis and related therapies. For the purpose of ISO 13958:2014, "concentrates" are a mixture of chemicals and water, or chemicals in the form of dry powder or other highly concentrated media, that are delivered to the end user to make dialysis fluid used to perform haemodialysis and related therapies. ISO 13958:2014 is addressed to the manufacturer of such concentrates.
ISO 13958:2014 includes concentrates in both liquid and powder forms. Also included are additives, also called spikes, which are chemicals that may be added to the concentrate to increase the concentration of one or more of the existing ions in the concentrate and thus in the final dialysis fluid. ISO 13958:2014 also gives requirements for equipment used to mix acid and bicarbonate powders into concentrate at the user's facility.

Related legislation

Legislation related to this standard

93/42/EEC

Medical devices

Life cycle

PREVIOUSLY

WITHDRAWN
EN 13867:2002+A1:2009

NOW

WITHDRAWN
EN ISO 13958:2015
99.60 Withdrawal effective
Mar 20, 2019

REVISED BY

WITHDRAWN
EN ISO 23500-4:2019

Relations

Adopted from ISO 13958:2014 IDENTICAL