EN ISO 13958:2015

Name: EN ISO 13958:2015
Brand: CEN

Superseded

View Superseded by

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

Superseded date

26-03-2022

Published date

02-12-2015

Publisher

Comite Europeen de Normalisation

European foreword
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Tests
6 Labelling
Annex A (informative) - Rationale for the
        development and provisions of this
        International Standard
Bibliography
Annex ZA (informative) - Relationship between
         this European Standard and the Essential
         Requirements of EU Directive 93/42/EEC on
         medical devices

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.

Committee	CEN/TC 205
DevelopmentNote	Supersedes EN 13867. (12/2015)
DocumentType	Standard
PublisherName	Comite Europeen de Normalisation
Status	Superseded
SupersededBy	EN ISO 23500-4:2019
Supersedes	EN 13867:2002+A1:2009

Standards	Relationship
DIN EN ISO 13958 E : 2016	Identical
UNI EN ISO 13958 : 2016	Identical
DIN EN ISO 13958:2016-03	Identical
NBN EN ISO 13958 : 2015	Identical
SN EN ISO 13958 : 2016	Identical
NEN EN ISO 13958 : 2015	Identical
NS EN ISO 13958 : 2015	Identical
I.S. EN ISO 13958:2015	Identical
PN EN ISO 13958 : 2016	Identical
ISO 13958:2014	Identical
BS EN ISO 13958:2015	Identical
NF EN ISO 13958 : 2016	Identical
UNE-EN ISO 13958:2016	Identical

ISO 11663:2014	Quality of dialysis fluid for haemodialysis and related therapies
IEC 60601-1:2005+AMD1:2012 CSV	Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-2-16 : 4.0	MEDICAL ELECTRICAL EQUIPMENT - PART 2-16: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HAEMODIALYSIS, HAEMODIAFILTRATION AND HAEMOFILTRATION EQUIPMENT
ISO 23500:2014	Guidance for the preparation and quality management of fluids for haemodialysis and related therapies
ISO 13959:2014	Water for haemodialysis and related therapies
ISO 14971:2007	Medical devices Application of risk management to medical devices
ISO 15223-1:2016	Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
IEC 61010-1:2010+AMD1:2016 CSV	Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
ISO 15223:2000	Medical devices Symbols to be used with medical device labels, labelling and information to be supplied