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Withdrawn
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
View Superseded by
Concentrates for haemodialysis and related therapies
Available format(s)
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
Withdrawn date
02-04-2019
Superseded by
Language(s)
French, English
Published date
17-03-2014
Important note : Users cannot be edited or removed once added to your Multi user PDF.
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Withdrawn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 |
| Standards | Relationship |
| GOST R ISO 13958 : 2015 | Identical |
| NF EN ISO 13958 : 2016 | Identical |
| NBN EN ISO 13958 : 2015 | Identical |
| NEN ISO 13958 : 2014 | 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 |
| SN EN ISO 13958 : 2016 | Identical |
| UNI EN ISO 13958 : 2016 | Identical |
| UNE-EN ISO 13958:2016 | Identical |
| BS EN ISO 13958:2015 | Identical |
| EN ISO 13958:2015 | Identical |
| CSA ISO 13958 : 2011 | Identical |
| DIN EN ISO 13958:2016-03 | Identical |
| 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) |
| AAMI 13959 : 2014 | WATER FOR HEMODIALYSIS AND RELATED THERAPIES |
| CSA ISO 11663 : 2015 | QUALITY OF DIALYSIS FLUID FOR HAEMODIALYSIS AND RELATED THERAPIES |
| 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 |
| 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 |
| 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 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 |
| 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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