AAMI RD52 : 2004
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
DIALYSATE FOR HEMODIALYSIS
07-09-2021
01-01-2010
Glossary of equivalent standards
Committee representation
Foreword
Introduction: Need for this AAMI recommended practice
Changes to ANSI/AAMI RD52:2004, as a result of Amendments
1 - 4
1 Scope
1.1 General
1.2 Inclusions
1.3 Exclusions
2 Normative references
3 Definitions
4 Fluid quality
4.1 Water
4.1.1 Maximum level of chemical contaminants in water
4.1.2 Bacteriology of water
4.2 Concentrate
4.2.1 Maximum level of chemical contaminants in
concentrate
4.2.2 Bacteriology of concentrate
4.3 Dialysate
4.3.1 Maximum level of chemical contaminants in
dialysate
4.3.2 Bacteriology of dialysate
5 Equipment
5.1 General
5.2 Water purification systems
5.2.1 General
5.2.2 Sediment filters
5.2.3 Cartridge filters
5.2.4 Softeners
5.2.5 Carbon adsorption
5.2.6 Chemical injection systems
5.2.7 Reverse osmosis
5.2.8 Deionization
5.2.9 Ultrafiltration
5.3 Water storage and distribution
5.3.1 General
5.3.2 Water storage
5.3.3 Water distribution systems
5.3.4 Bacterial control devices
5.4 Concentrate preparation
5.4.1 General
5.4.2 Materials compatibility
5.4.3 Bulk storage tanks (acid concentrate)
5.4.4 Mixing systems
5.4.5 Additives
5.5 Concentrate distribution
5.5.1 Materials compatibility
5.5.2 System configurations
5.5.3 Acid concentrate distribution systems
5.5.4 Bicarbonate concentrate distribution systems
5.5.5 Concentrate outlets
5.6 Dialysate proportioning
6 Monitoring
6.1 General
6.2 Water purification
6.2.1 General
6.2.2 Sediment filters
6.2.3 Cartridge filters
6.2.4 Softeners
6.2.5 Carbon adsorption
6.2.6 Chemical injection systems
6.2.7 Reverse osmosis
6.2.8 Deionization
6.2.9 Ultrafiltration
6.3 Water storage and distribution
6.3.1 General
6.3.2 Water storage
6.3.3 Water distribution systems
6.3.4 Bacterial control devices
6.4 Concentrate preparation
6.4.1 Mixing systems
6.4.2 Additives
6.5 Concentrate distribution
6.6 Dialysate proportioning
7 Strategies for bacterial control
7.1 General
7.2 Microbial monitoring methods
7.2.1 General
7.2.2 Sample collection
7.2.3 Heterotrophic plate count
7.2.4 Bacterial endotoxin test
8 Environment
9 Personnel
Annexes
A - Rationale for the development and provisions of this
recommended practice
B - Bibliography
C - Special considerations for home hemodialysis
D - Self-assessment of compliance with recommendations
for dialysate preparation
E - Special considerations for acute hemodialysis
Gives guidance to dialysis practitioners on the preparation of dialysate for hemodialysis and related therapies, from the point at which municipal water enters their dialysis facility to the point at which the final dialysate enters the dialyzer.
Committee |
TG 05
|
DevelopmentNote |
AMD 1, AMD 2, AMD 3 and AMD 4 are not available separately, incorporated in 2004 edition. (05/2009)
|
DocumentType |
Standard
|
PublisherName |
Association for the Advancement of Medical Instrumentation
|
Status |
Superseded
|
SupersededBy |
I.S. EN ISO 11663:2015 | QUALITY OF DIALYSIS FLUID FOR HAEMODIALYSIS AND RELATED THERAPIES (ISO 11663:2014) |
AAMI TIR 43 : 2011 | ULTRAPURE DIALYSATE FOR HEMODIALYSIS AND RELATED THERAPIES |
CSA 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 |
BS EN ISO 11663:2015 | Quality of dialysis fluid for haemodialysis and related therapies |
AAMI 11663 : 2014 | QUALITY OF DIALYSIS FLUID FOR HEMODIALYSIS AND RELATED THERAPIES |
AAMI TIR58 : 2014 | WATER TESTING METHODOLOGIES |
ISO 11663:2014 | Quality of dialysis fluid for haemodialysis and related therapies |
AAMI RD47 : 2008 | REPROCESSING OF HEMODIALYZERS |
UNE-EN ISO 11663:2016 | Quality of dialysis fluid for haemodialysis and related therapies (ISO 11663:2014) |
EN ISO 11663:2015 | Quality of dialysis fluid for haemodialysis and related therapies (ISO 11663:2014) |
AAMI TIR72 : 2017 | DIALYSIS FLUID CHEMICAL COMPOSITION |
AAMI ISO 11663 : 2009 | QUALITY OF DIALYSIS FLUID FOR HAEMODIALYSIS AND RELATED THERAPIES |
DIN EN ISO 11663:2016-02 | QUALITY OF DIALYSIS FLUID FOR HAEMODIALYSIS AND RELATED THERAPIES (ISO 11663:2014) |
AAMI RD5 : 2003 | HEMODIALYSIS SYSTEMS |
AAMI RD62 : 2006 | WATER TREATMENT EQUIPMENT FOR HEMODIALYSIS APPLICATIONS |
AAMI RD61 : 2006 | CONCENTRATES FOR HEMODIALYSIS |
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