Phone: (011) 7541-421, 3409-301, 3409-335, 6547-293, 3409-310
E-mail: Standards sales: prodaja@iss.rs Education: iss-edukacija@iss.rs Information about standards: infocentar@iss.rs
Stevana Brakusa 2, 11030 Beograd
Main menu

SRPS EN ISO 13958:2017

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

Jan 31, 2017
95.99 Withdrawal of Standard   Jul 31, 2019

General information

95.99     Jul 31, 2019

ISS

Z076

European Norm

11.040.40     11.040.20  

English  

Buying

Withdrawn

Language in which you want to receive the document.

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 directives

Directives related to this standard.

93/42/EEC

Medical devices

Life cycle

PREVIOUSLY

WITHDRAWN
SRPS EN 13867:2011

PUBLISHED
SRPS EN 13868:2011

NOW

WITHDRAWN
SRPS EN ISO 13958:2017
95.99 Withdrawal of Standard
Jul 31, 2019

REVISED BY

PUBLISHED
SRPS EN ISO 23500-4:2019

Related project

Adopted from EN ISO 13958:2015

Adopted from ISO 13958:2014 IDENTICAL