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ISO 13958:2014

Withdrawn
Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

View Superseded by
withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

Concentrates for haemodialysis and related therapies
Available format(s)

Hardcopy , PDF 1 User , PDF 3 Users , PDF 5 Users , PDF 9 Users

Withdrawn date

02-04-2019

Language(s)

French, English

Published date

17-03-2014

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.

DevelopmentNote
Supersedes ISO/FDIS 13958. (03/2014)
DocumentType
Standard
Pages
29
PublisherName
International Organization for Standardization
Status
Withdrawn
SupersededBy
Supersedes

DIN EN ISO 11663 E : 2016 QUALITY OF DIALYSIS FLUID FOR HAEMODIALYSIS AND RELATED THERAPIES (ISO 11663:2014)
UNE-EN ISO 13959:2016 Water for haemodialysis and related therapies (ISO 13959:2014)
AAMI ISO 11663 : 2009 QUALITY OF DIALYSIS FLUID FOR HAEMODIALYSIS AND RELATED THERAPIES
ISO 16142-1:2016 Medical devices — Recognized essential principles of safety and performance of medical devices — Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
10/30201925 DC : 0 BS ISO 23500 - GUIDANCE FOR THE PREPARATION AND QUALITY MANAGEMENT OF FLUIDS FOR HAEMODIALYSIS AND RELATED THERAPIES
CSA Z23500 : 2016 GUIDANCE FOR THE PREPARATION AND QUALITY MANAGEMENT OF FLUIDS FOR HAEMODIALYSIS AND RELATED THERAPIES
I.S. EN ISO 11663:2015 QUALITY OF DIALYSIS FLUID FOR HAEMODIALYSIS AND RELATED THERAPIES (ISO 11663:2014)
EN 60601-2-16:2015 Medical electrical equipment - Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
ISO/TR 20520:2018 Traditional Chinese medicine Infection control for acupuncture treatment
DIN EN ISO 11663:2016-02 QUALITY OF DIALYSIS FLUID FOR HAEMODIALYSIS AND RELATED THERAPIES (ISO 11663:2014)
BS EN ISO 11663:2015 Quality of dialysis fluid for haemodialysis and related therapies
BS ISO 11663 : 2014 QUALITY OF DIALYSIS FLUID FOR HAEMODIALYSIS AND RELATED THERAPIES
DIN EN ISO 13959:2016-03 WATER FOR HAEMODIALYSIS AND RELATED THERAPIES (ISO 13959:2014)
BS ISO 13959 : 2014 WATER FOR HAEMODIALYSIS AND RELATED THERAPIES
BS EN ISO 23500:2015 Guidance for the preparation and quality management of fluids for haemodialysis and related therapies
AAMI IEC 60601-2-16 : 2012 MEDICAL ELECTRICAL EQUIPMENT - PART 2-16: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HEMODIALYSIS, HEMODIAFILTRATION AND HEMOFILTRATION EQUIPMENT
I.S. EN 60601-2-16:2015 MEDICAL ELECTRICAL EQUIPMENT - PART 2-16: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HAEMODIALYSIS, HAEMODIAFILTRATION AND HAEMOFILTRATION EQUIPMENT
13/30270471 DC : 0 BS ISO 13959 - WATER FOR HAEMODIALYSIS AND RELATED THERAPIES
BS EN ISO 13959:2015 Water for haemodialysis and related therapies
13/30270474 DC : 0 BS ISO 23500 - GUIDANCE FOR THE PREPARATION AND QUALITY MANAGEMENT OF FLUIDS FOR HAEMODIALYSIS AND RELATED THERAPIES
DIN EN ISO 23500:2015-12 GUIDANCE FOR THE PREPARATION AND QUALITY MANAGEMENT OF FLUIDS FOR HAEMODIALYSIS AND RELATED THERAPIES (ISO 23500:2014)
BS ISO 16142-1:2016 Medical devices. Recognized essential principles of safety and performance of medical devices General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
AAMI ISO 23500 : 2011 GUIDANCE FOR THE PREPARATION AND QUALITY MANAGEMENT OF FLUIDS FOR HEMODIALYSIS AND RELATED THERAPIES
I.S. EN ISO 23500:2015 GUIDANCE FOR THE PREPARATION AND QUALITY MANAGEMENT OF FLUIDS FOR HAEMODIALYSIS AND RELATED THERAPIES (ISO 23500:2014)
AAMI 11663 : 2014 QUALITY OF DIALYSIS FLUID FOR HEMODIALYSIS AND RELATED THERAPIES
BS EN 60601-2-16:2015 Medical electrical equipment Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
AAMI 23500 : 2014 GUIDANCE FOR THE PREPARATION AND QUALITY MANAGEMENT OF FLUIDS FOR HEMODIALYSIS AND RELATED THERAPIES
08/30179572 DC : DRAFT MAR 2008 BS ISO 11663 - QUALITY OF DIALYSIS FLUID FOR HAEMODIALYSIS AND RELATED THERAPIES
UNE-EN ISO 11663:2016 Quality of dialysis fluid for haemodialysis and related therapies (ISO 11663:2014)
DIN EN ISO 23500 E : 2015 GUIDANCE FOR THE PREPARATION AND QUALITY MANAGEMENT OF FLUIDS FOR HAEMODIALYSIS AND RELATED THERAPIES (ISO 23500:2014)
AAMI 13959 : 2014 WATER FOR HEMODIALYSIS AND RELATED THERAPIES
CSA ISO 11663 : 2015 QUALITY OF DIALYSIS FLUID FOR HAEMODIALYSIS AND RELATED THERAPIES
CSA C22.2 No. 60601.2.16 : 2014(R2019) MEDICAL ELECTRICAL EQUIPMENT - PART 2-16: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HAEMODIALYSIS, HAEMODIAFILTRATION AND HAEMOFILTRATION EQUIPMENT
ISO 13959:2014 Water for haemodialysis and related therapies
ISO 23500:2014 Guidance for the preparation and quality management of fluids for haemodialysis and related therapies
EN ISO 23500:2015 Guidance for the preparation and quality management of fluids for haemodialysis and related therapies (ISO 23500:2014)
EN ISO 13959:2015 Water for haemodialysis and related therapies (ISO 13959:2014)
EN ISO 11663:2015 Quality of dialysis fluid for haemodialysis and related therapies (ISO 11663:2014)
13/30270465 DC : 0 BS ISO 11663 - QUALITY OF DIALYSIS FLUID FOR HAEMODIALYSIS AND RELATED THERAPIES
DIN EN ISO 13959 E : 2016 WATER FOR HAEMODIALYSIS AND RELATED THERAPIES (ISO 13959:2014)
I.S. EN ISO 13959:2015 WATER FOR HAEMODIALYSIS AND RELATED THERAPIES (ISO 13959:2014)
AAMI ISO 13959 : 2009 WATER FOR HEMODIALYSIS AND RELATED THERAPIES
BS ISO 23500 : 2014 GUIDANCE FOR THE PREPARATION AND QUALITY MANAGEMENT OF FLUIDS FOR HAEMODIALYSIS AND RELATED THERAPIES
UNE-EN ISO 23500:2016 Guidance for the preparation and quality management of fluids for haemodialysis and related therapies (ISO 23500:2014)
AAMI RD61 : 2006 CONCENTRATES FOR HEMODIALYSIS
ISO 11663:2014 Quality of dialysis fluid for haemodialysis and related therapies

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

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